MedPath

Etanercept Withdrawal And Retreament Study In Subjects With Nr-ax SpA

Phase 4
Completed
Conditions
Spondylitis, Ankylosing
Interventions
Biological: Etanercept
Registration Number
NCT02509026
Lead Sponsor
Pfizer
Brief Summary

The purpose of this study is to study the benefits and risks of etanercept withdrawal in patients who have achieved a significant clinical response.

Detailed Description

This multcenter, open-label, three period study will evaluate withdrawal and retreatment of etanercept in subjects with nr-ax SpA who achieved adequate response following 24 weeks of treatment.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
210
Inclusion Criteria
  • diagnosis of axial SpA duration of symptoms >3 months and <5 years back pain with a less than favorable response to NSAIDs
Exclusion Criteria
  • radiological sacroiliitis previous treatment with TNF inhibitor, biologic, immunosuppressive

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
EtanerceptEtanerceptetanercept 50 mg QW
Primary Outcome Measures
NameTimeMethod
Percentage of Participants Who Experienced Flare Within 40 Weeks Following Withdrawal of 24 Weeks of Etanercept TreatmentWithin 40 weeks after Etanercept withdrawal (from Week 24 to Week 64)

Participants who experienced ASDAS-Erythrocyte Sedimentation Rate (ESR) level of \>=2.1 were defined as being flared. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 10= high disease activity. CRP measured in milligram per liter (mg/L) and ESR measured in millimeter per hour (mm/hr). Percentage of participants who flared within 40 weeks after the withdrawal of Etanercept treatment of 24 weeks in Induction period are reported in this outcome measure.

Secondary Outcome Measures
NameTimeMethod
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 3Week 68, 72, 76

ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0 \<= ASDAS-CRP \<1.3; moderate disease activity: 1.3 \<= ASDAS-CRP \<2.1; high disease activity: 2.1 \<= ASDAS-CRP \<=3.5; very high disease activity: 3.5 \< ASDAS-CRP.

Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<) 1.3: Last Observation Carried Forward (LOCF): Period 3Week 68, 72, 76

ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0 \<= ASDAS-CRP \<1.3; moderate disease activity: 1.3 \<= ASDAS-CRP \<2.1; high disease activity: 2.1 \<= ASDAS-CRP \<=3.5; very high disease activity: 3.5 \< ASDAS-CRP.

Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Observed Cases (OC): Period 1Week 4, 8, 12, 16, 24

ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 40 responders were defined as participants with at least 40% and absolute improvement of at least 2 units on a 0 to 10 cm scale (converted from 0 to 100 mm) or an improvement of 100% for those domains that have a baseline score \<2 in at least 3 of the 4 domains: participant assessment of disease activity, mean of participants assessment of total back pain, function represented by the BASFI score, inflammation represented by the mean of the two morning stiffness-related BASDAI scores. No worsening at all in any of the domains. Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 40.

Time to Flare Following Withdrawal of Etanercept TreatmentWithin 40 weeks after Etanercept withdrawal (from Week 24 to Week 64)

Participants who experienced ASDAS-ESR level of \>=2.1 were defined as being flared. Time to experience flare in participants was defined as time to achieve ASDAS-ESR level of \>=2.1 after the withdrawal of Etanercept treatment of 24 weeks in induction period. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr.

Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 1Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24

ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0 \<= ASDAS-CRP \<1.3; moderate disease activity: 1.3 \<= ASDAS-CRP \<2.1; high disease activity: 2.1 \<= ASDAS-CRP \<=3.5; very high disease activity: 3.5 \< ASDAS-CRP.

Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Last Observation Carried Forward (LOCF): Period 3Week 64, 68, 72, 76

ASAS partial remission was defined as a score of 2 units or less (on a scale of 0-10 cm, where 0 = no disease activity and 10 = high disease activity) in each of the 4 domains of ASAS: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). Reported values were then converted into cm for analysis.

Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<) 1.3: Last Observation Carried Forward (LOCF): Period 1Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24

ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0 \<= ASDAS-CRP \<1.3; moderate disease activity: 1.3 \<= ASDAS-CRP \<2.1; high disease activity: 2.1 \<= ASDAS-CRP \<=3.5; very high disease activity: 3.5 \< ASDAS-CRP.

Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<) 1.3: Last Observation Carried Forward (LOCF): Period 2Week 28, 32, 40, 48, 56, 64

ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0 \<= ASDAS-CRP \<1.3; moderate disease activity: 1.3 \<= ASDAS-CRP \<2.1; high disease activity: 2.1 \<= ASDAS-CRP \<=3.5; very high disease activity: 3.5 \< ASDAS-CRP.

Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 2Week 28, 32, 40, 48, 56, 64

ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 20 responders were defined as participants with at least 20% improvement from baseline in disease activity and an absolute change of at least 1 unit on a 0 to 10 cm scale (0=no disease activity; 10=high disease activity, where higher scores indicated higher disease activity) in 3 or more domains, and no worsening of \>=20% and absolute change 1 unit in the remaining domain. All 4 domains were measured on a 0-100 millimeter (mm) scale (0= no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 20.

Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 2Week 28, 32, 40, 48, 56, 64

ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0 \<= ASDAS-CRP \<1.3; moderate disease activity: 1.3 \<= ASDAS-CRP \<2.1; high disease activity: 2.1 \<= ASDAS-CRP \<=3.5; very high disease activity: 3.5 \< ASDAS-CRP.

Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Last Observation Carried Forward (LOCF): Period 1Week 4, 8, 12, 16, 24

ASAS partial remission was defined as a score of 2 units or less (on a scale of 0-10 cm, where 0 = no disease activity and 10 = high disease activity) in each of the 4 domains of ASAS: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). Reported values were then converted into cm for analysis.

Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 2Week 28, 32, 40, 48, 56, 64

ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 20 responders were defined as participants with at least 20% improvement from baseline in disease activity and an absolute change of at least 1 unit on a 0 to 10 cm scale (0=no disease activity; 10=high disease activity, where higher scores indicated higher disease activity) in 3 or more domains, and no worsening of \>=20% and absolute change 1 unit in the remaining domain. All 4 domains were measured on a 0-100 millimeter (mm) scale (0= no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 20.

Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Last Observation Carried Forward (LOCF): Period 1Week 4, 8, 12, 16, 24

ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 40 responders were defined as participants with at least 40% and absolute improvement of at least 2 units on a 0 to 10 cm scale (converted from 0 to 100 mm) or an improvement of 100% for those domains that have a baseline score \<2 in at least 3 of the 4 domains: participant assessment of disease activity, mean of participants assessment of total back pain, function represented by the BASFI score, inflammation represented by the mean of the two morning stiffness-related BASDAI scores. No worsening at all in any of the domains. Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 40.

Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Last Observation Carried Forward (LOCF): Period 2Week 28, 32, 40, 48, 56, 64

ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 40 responders were defined as participants with at least 40% and absolute improvement of at least 2 units on a 0 to 10 cm scale (converted from 0 to 100 mm) or an improvement of 100% for those domains that have a baseline score \<2 in at least 3 of the 4 domains: participant assessment of disease activity, mean of participants assessment of total back pain, function represented by the BASFI score, inflammation represented by the mean of the two morning stiffness-related BASDAI scores. No worsening at all in any of the domains. Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 40.

Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 1Week 4, 8, 12, 16, 24

ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from \[Bath Ankylosing Spondylitis Functional Index\] BASFI) and inflammation (from \[Bath Ankylosing Spondylitis Disease Activity Index\] BASDAI). ASAS 20 responders were defined as participants with at least 20% improvement from baseline in disease activity and an absolute change of at least 1 unit on a 0 to 10 cm scale (0=no disease activity; 10=high disease activity, where higher scores indicated higher disease activity) in 3 or more domains, and no worsening of \>=20% and absolute change 1 unit in the remaining domain. All 4 domains were measured on a 0-100 millimeter (mm) scale (0= no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 20.

Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 3Week 64, 68, 72, 76

ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 20 responders: participants with at least 20% improvement from baseline in disease activity and an absolute change of at least 1 unit on 0 to 10 cm scale(0=no disease activity; 10=high disease activity, where higher scores indicated higher disease activity)in 3 or more domains, and no worsening of \>=20% and absolute change 1 unit in the remaining domain. All 4 domains measured on 0-100 millimeter (mm) scale (0= no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 20.

Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Observed Cases (OC): Period 2Week 28, 32, 40, 48, 56, 64

ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 40 responders were defined as participants with at least 40% and absolute improvement of at least 2 units on a 0 to 10 cm scale (converted from 0 to 100 mm) or an improvement of 100% for those domains that have a baseline score \<2 in at least 3 of the 4 domains: participant assessment of disease activity, mean of participants assessment of total back pain, function represented by the BASFI score, inflammation represented by the mean of the two morning stiffness-related BASDAI scores. No worsening at all in any of the domains. Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 40.

Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76

ASDAS: score combining assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on VAS ranging 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0\<= ASDAS-CRP \<1.3; moderate disease activity: 1.3\<= ASDAS-CRP \<2.1; high disease activity: 2.1\<= ASDAS-CRP \<=3.5; very high disease activity: 3.5\< ASDAS-CRP. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\*participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln(CRP+1), Ln represents the natural logarithm.

Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 3Week 64, 68, 72, 76

ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 20 responders: participants with at least 20% improvement from baseline in disease activity and an absolute change of at least 1 unit on 0 to 10 cm scale(0=no disease activity; 10=high disease activity, where higher scores indicated higher disease activity)in 3 or more domains, and no worsening of \>=20% and absolute change 1 unit in the remaining domain. All 4 domains measured on 0-100 millimeter (mm) scale (0= no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 20.

Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 1Week 4, 8, 12, 16, 24

ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 20 responders were defined as participants with at least 20% improvement from baseline in disease activity and an absolute change of at least 1 unit on a 0 to 10 cm scale (0=no disease activity; 10=high disease activity, where higher scores indicated higher disease activity) in 3 or more domains, and no worsening of \>=20% and absolute change 1 unit in the remaining domain. All 4 domains were measured on a 0-100 millimeter (mm) scale (0= no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 20.

Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Last Observation Carried Forward (LOCF): Period 3Week 64, 68, 72, 76

ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 40 responders were defined as participants with at least 40% and absolute improvement of at least 2 units on a 0 to 10 cm scale (converted from 0 to 100 mm) or an improvement of 100% for those domains that have a baseline score \<2 in at least 3 of the 4 domains: participant assessment of disease activity, mean of participants assessment of total back pain, function represented by the BASFI score, inflammation represented by the mean of the two morning stiffness-related BASDAI scores. No worsening at all in any of the domains. Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 40.

Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Last Observation Carried Forward (LOCF): Period 2Week 28, 32, 40, 48, 56, 64

ASAS partial remission was defined as a score of 2 units or less (on a scale of 0-10 cm, where 0 = no disease activity and 10 = high disease activity) in each of the 4 domains of ASAS: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). Reported values were then converted into cm for analysis.

Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3: Baseline (last visit before retreatment), Week 64, 68, 72, 76

ASDAS: score combining assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on VAS ranging 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0\<= ASDAS-CRP \<1.3; moderate disease activity: 1.3\<= ASDAS-CRP \<2.1; high disease activity: 2.1\<= ASDAS-CRP \<=3.5; very high disease activity: 3.5\< ASDAS-CRP. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\*participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln(CRP+1), Ln represents the natural logarithm.

Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Observed Cases (OC): Period 3Week 64, 68, 72, 76

ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 40 responders were defined as participants with at least 40% and absolute improvement of at least 2 units on a 0 to 10 cm scale (converted from 0 to 100 mm) or an improvement of 100% for those domains that have a baseline score \<2 in at least 3 of the 4 domains: participant assessment of disease activity, mean of participants assessment of total back pain, function represented by the BASFI score, inflammation represented by the mean of the two morning stiffness-related BASDAI scores. No worsening at all in any of the domains. Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 40.

Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Observed Cases (OC): Period 2Week 28, 32, 40, 48, 56, 64

ASAS partial remission was defined as a score of 2 units or less (on a scale of 0-10 cm, where 0 = no disease activity and 10 = high disease activity) in each of the 4 domains of ASAS: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). Reported values were then converted into cm for analysis.

Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Observed Cases (OC): Period 3Week 64, 68, 72, 76

ASAS partial remission was defined as a score of 2 units or less (on a scale of 0-10 cm, where 0 = no disease activity and 10 = high disease activity) in each of the 4 domains of ASAS: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). Reported values were then converted into cm for analysis.

Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 1Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24

ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 100= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS-ESR was calculated with the following equation: 0.8\*total back pain+0.11\*participant global+0.09\*peripheral pain/swelling+0.07\*duration of morning stiffness+ 0.29\*ESR\^1/2. ASDAS ranged as inactive disease: 0 \<= ASDAS-ESR \<1.3; active disease: 1.3 \<= ASDAS-ESR =\<2.1.

Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Last Observation Carried Forward (LOCF): Period 2Week 28, 32, 40, 48, 56, 64

Major improvement in ASDAS-CRP was defined as decrease from baseline \>= 2.0 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\*participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln(CRP+1), Ln represents the natural logarithm.

Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Observed Cases (OC): Period 1Week 4, 8, 12, 16, 24

ASAS partial remission was defined as a score of 2 units or less (on a scale of 0-10 cm, where 0 = no disease activity and 10 = high disease activity) in each of the 4 domains of ASAS: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). Reported values were then converted into cm for analysis.

Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 1Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24

ASDAS: score combining assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on VAS ranging 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0\<= ASDAS-CRP \<1.3; moderate disease activity: 1.3\<= ASDAS-CRP \<2.1; high disease activity: 2.1\<= ASDAS-CRP \<=3.5; very high disease activity: 3.5\< ASDAS-CRP. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\*participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln(CRP+1), Ln represents the natural logarithm.

Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64

ASDAS: score combining assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on VAS ranging 0-10 cm,where 0= no disease activity and 10= high disease activity.CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0\<= ASDAS-CRP \<1.3; moderate disease activity: 1.3\<= ASDAS-CRP \<2.1; high disease activity: 2.1\<= ASDAS-CRP \<=3.5; very high disease activity: 3.5\< ASDAS-CRP. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\*participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln(CRP+1), Ln represents the natural logarithm.

Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64

ASDAS: score combining assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on VAS ranging 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0\<= ASDAS-CRP \<1.3; moderate disease activity: 1.3\<= ASDAS-CRP \<2.1; high disease activity: 2.1\<= ASDAS-CRP \<=3.5; very high disease activity: 3.5\< ASDAS-CRP. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\*participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln(CRP+1), Ln represents the natural logarithm.

Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 1Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24

ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 100= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS-ESR was calculated with the following equation: 0.8\*total back pain+0.11\*participant global+0.09\*peripheral pain/swelling+0.07\*duration of morning stiffness+ 0.29\*ESR\^1/2. ASDAS ranged as inactive disease: 0 \<= ASDAS-ESR \<1.3; active disease: 1.3 \<= ASDAS-ESR =\<2.1.

Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Last Observation Carried Forward (LOCF): Period 1Week 4, 8, 12, 16, 24

Major improvement in ASDAS-CRP was defined as decrease from baseline \>= 2.0 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\*participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln(CRP+1), Ln represents the natural logarithm.

Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 1Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24

Participants assessed their nocturnal back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to centimeter (cm) for analysis.

Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 1Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24

ASDAS: score combining assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on VAS ranging 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0\<= ASDAS-CRP \<1.3; moderate disease activity: 1.3\<= ASDAS-CRP \<2.1; high disease activity: 2.1\<= ASDAS-CRP \<=3.5; very high disease activity: 3.5\< ASDAS-CRP. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\*participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln(CRP+1), Ln represents the natural logarithm.

Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76

ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 100= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS-ESR was calculated with the following equation: 0.8\*total back pain+0.11\*participant global+0.09\*peripheral pain/swelling+0.07\*duration of morning stiffness+ 0.29\*ESR\^1/2. ASDAS ranged as inactive disease: 0 \<= ASDAS-ESR \<1.3; active disease: 1.3 \<= ASDAS-ESR =\<2.1.

Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Observed Cases (OC): Period 2Week 28, 32, 40, 48, 56, 64

Major improvement in ASDAS-CRP was defined as decrease from baseline \>= 2.0 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\*participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln(CRP+1), Ln represents the natural logarithm.

Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Observed Cases (OC): Period 1Week 4, 8, 12, 16, 24

ASDAS-CRP clinically important improvement was defined as a decrease from baseline of \>=1.1 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\* participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln (CRP+1), Ln represents the natural logarithm.

Change From Baseline in Total Back Pain: Observed Cases (OC): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76

Participants assessed their total back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis.

Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64

ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 100= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS-ESR was calculated with the following equation: 0.8\*total back pain+0.11\*participant global+0.09\*peripheral pain/swelling+0.07\*duration of morning stiffness+ 0.29\*ESR\^1/2. ASDAS ranged as inactive disease: 0 \<= ASDAS-ESR \<1.3; active disease: 1.3 \<= ASDAS-ESR =\<2.1.

Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Last Observation Carried Forward (LOCF): Period 3Week 64, 68, 72, 76

Major improvement in ASDAS-CRP was defined as decrease from baseline \>= 2.0 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\*participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln(CRP+1), Ln represents the natural logarithm.

Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 1Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24

BASFI is composed of 10 questions related to the participant's ability to function. Each question scored by the participant on a 100 mm scale ranging from 0 (easy) to 100 (impossible), where higher scores indicated more difficulty in participant's ability to function. The BASFI total score calculated as mean of the scores for these 10 questions and converted to cm for analysis. BASFI total score was ranged from 0 (easy) to 10 (impossible), where higher scores indicated more difficulty in participant's ability to function due to ankylosing spondylitis.

Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64

BASDAI consisted of 6 questions related to disease activity. Each of the first 5 questions was scored by the participant on a 100 mm scale ranging from 0 (none) to 100 (very severe), where higher scores indicated more severe disease activity. The sixth question, related to duration of morning stiffness measured on a scale for 0 (0 hours) to 100 (2 hours), where higher scores indicated larger duration of morning stiffness. The BASDAI score was obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 \[severity of morning stiffness\] and 6 \[duration of morning stiffness\]) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The BASDAI total score ranged from 0 to 10, where higher scores indicated more severe disease activity. The reported values were converted to cm for analysis.

Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64

ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 100= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS-ESR was calculated with the following equation: 0.8\*total back pain+0.11\*participant global+0.09\*peripheral pain/swelling+0.07\*duration of morning stiffness+ 0.29\*ESR\^1/2. ASDAS ranged as inactive disease: 0 \<= ASDAS-ESR \<1.3; active disease: 1.3 \<= ASDAS-ESR =\<2.1.

Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76

ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 100= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS-ESR was calculated with the following equation: 0.8\*total back pain+0.11\*participant global+0.09\*peripheral pain/swelling+0.07\*duration of morning stiffness+ 0.29\*ESR\^1/2. ASDAS ranged as inactive disease: 0 \<= ASDAS-ESR \<1.3; active disease: 1.3 \<= ASDAS-ESR =\<2.1.

Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Observed Cases (OC): Period 3Week 64, 68, 72, 76

Major improvement in ASDAS-CRP was defined as decrease from baseline \>= 2.0 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\*participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln(CRP+1), Ln represents the natural logarithm.

Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Last Observation Carried Forward (LOCF): Period 2Week 28, 32, 40, 48, 56, 64

ASDAS-CRP clinically important improvement was defined as a decrease from baseline of \>=1.1 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\* participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln (CRP+1), Ln represents the natural logarithm.

Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64

Participants assessed their nocturnal back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis.

Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 1Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24

Participants assessed their nocturnal back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis.

Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64

Participants assessed their total back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis.

Change From Baseline in Total Back Pain: Observed Cases (OC): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64

Participants assessed their total back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis.

Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Observed Cases (OC): Period 1Week 4, 8, 12, 16, 24

Major improvement in ASDAS-CRP was defined as decrease from baseline \>= 2.0 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\*participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln(CRP+1), Ln represents the natural logarithm.

Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Last Observation Carried Forward (LOCF): Period 1Week 4, 8, 12, 16, 24

ASDAS-CRP clinically important improvement was defined as a decrease from baseline of \>=1.1 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\* participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln (CRP+1), Ln represents the natural logarithm.

Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76

Participants assessed their nocturnal back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis.

Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64

Participants assessed their nocturnal back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis.

Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76

Participants assessed their nocturnal back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis.

Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 1Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24

Participants assessed their total back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis.

Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76

Participants assessed their total back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis.

Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Last Observation Carried Forward (LOCF): Period 3Week 64, 68, 72, 76

ASDAS-CRP clinically important improvement was defined as a decrease from baseline of \>=1.1 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\* participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln (CRP+1), Ln represents the natural logarithm.

Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Observed Cases (OC): Period 2Week 28, 32, 40, 48, 56, 64

ASDAS-CRP clinically important improvement was defined as a decrease from baseline of \>=1.1 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\* participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln (CRP+1), Ln represents the natural logarithm.

Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Observed Cases (OC): Period 3Week 64, 68, 72, 76

ASDAS-CRP clinically important improvement was defined as a decrease from baseline of \>=1.1 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\* participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln (CRP+1), Ln represents the natural logarithm.

Change From Baseline in Total Back Pain: Observed Cases (OC): Period 1Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24

Participants assessed their total back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis.

Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 1Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24

BASFI is composed of 10 questions related to the participant's ability to function. Each question scored by the participant on a 100 mm scale ranging from 0 (easy) to 100 (impossible), where higher scores indicated more difficulty in participant's ability to function. The BASFI total score calculated as mean of the scores for these 10 questions and converted to cm for analysis. BASFI total score was ranged from 0 (easy) to 10 (impossible), where higher scores indicated more difficulty in participant's ability to function due to ankylosing spondylitis.

Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64

BASFI is composed of 10 questions related to the participant's ability to function. Each question scored by the participant on a 100 mm scale ranging from 0 (easy) to 100 (impossible), where higher scores indicated more difficulty in participant's ability to function. The BASFI total score calculated as mean of the scores for these 10 questions and converted to cm for analysis. BASFI total score was ranged from 0 (easy) to 10 (impossible), where higher scores indicated more difficulty in participant's ability to function due to ankylosing spondylitis.

Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64

BASFI is composed of 10 questions related to the participant's ability to function. Each question scored by the participant on a 100 mm scale ranging from 0 (easy) to 100 (impossible), where higher scores indicated more difficulty in participant's ability to function. The BASFI total score calculated as mean of the scores for these 10 questions and converted to cm for analysis. BASFI total score was ranged from 0 (easy) to 10 (impossible), where higher scores indicated more difficulty in participant's ability to function due to ankylosing spondylitis.

Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76

BASFI is composed of 10 questions related to the participant's ability to function. Each question scored by the participant on a 100 mm scale ranging from 0 (easy) to 100 (impossible), where higher scores indicated more difficulty in participant's ability to function. The BASFI total score calculated as mean of the scores for these 10 questions and converted to cm for analysis. BASFI total score was ranged from 0 (easy) to 10 (impossible), where higher scores indicated more difficulty in participant's ability to function due to ankylosing spondylitis.

Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 1Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24

BASDAI consisted of 6 questions related to disease activity. Each of the first 5 questions was scored by the participant on a 100 mm scale ranging from 0 (none) to 100 (very severe), where higher scores indicated more severe disease activity. The sixth question, related to duration of morning stiffness measured on a scale for 0 (0 hours) to 100 (2 hours), where higher scores indicated larger duration of morning stiffness. The BASDAI score was obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 \[severity of morning stiffness\] and 6 \[duration of morning stiffness\]) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The BASDAI total score ranged from 0 to 10, where higher scores indicated more severe disease activity. The reported values were converted to cm for analysis.

Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Last Observation Carried Forward (LOCF): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76

BASDAI consisted of 6 questions related to disease activity. Each of the first 5 questions was scored by the participant on a 100 mm scale ranging from 0 (none) to 100 (very severe), where higher scores indicated more severe disease activity. The sixth question, related to duration of morning stiffness measured on a scale for 0 (0 hours) to 100 (2 hours), where higher scores indicated larger duration of morning stiffness. The BASDAI score was obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 \[severity of morning stiffness\] and 6 \[duration of morning stiffness\]) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The BASDAI total score ranged from 0 to 10, where higher scores indicated more severe disease activity. The reported values were converted to cm for analysis.

Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) :Last Observation Carried Forward (LOCF): Period 1Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24

50% improvement from baseline in BASDAI: percentage of participants who achieved 50% decrease from baseline in their BASDAI total score. BASDAI consisted: 6 questions (Q) related to disease activity. Each of first 5 questions was scored by participant on 100 mm scale, range 0=none to 100=very severe, higher scores = more severe disease activity. Sixth question: duration of morning stiffness, was on scale for 0=0 hours to 100=2 hours, higher scores = larger duration of morning stiffness. BASDAI score was obtained by computing mean score for 2 questions related to morning stiffness (Q5 \[severity of morning stiffness\], Q6 \[duration of morning stiffness\]) and adding that value to sum of the scores for first 4Q and then dividing total by 5. BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. BASDAI total score ranged from 0 to 10, higher scores = more severe disease activity. Reported values were converted to cm for analysis. Improvement was relative to baseline (Day 1).

Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 1Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24

Change from baseline in hsCRP levels were reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation.

Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76

BASFI is composed of 10 questions related to the participant's ability to function. Each question scored by the participant on a 100 mm scale ranging from 0 (easy) to 100 (impossible), where higher scores indicated more difficulty in participant's ability to function. The BASFI total score calculated as mean of the scores for these 10 questions and converted to cm for analysis. BASFI total score was ranged from 0 (easy) to 10 (impossible), where higher scores indicated more difficulty in participant's ability to function due to ankylosing spondylitis.

Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76

BASDAI consisted of 6 questions related to disease activity. Each of the first 5 questions was scored by the participant on a 100 mm scale ranging from 0 (none) to 100 (very severe), where higher scores indicated more severe disease activity. The sixth question, related to duration of morning stiffness measured on a scale for 0 (0 hours) to 100 (2 hours), where higher scores indicated larger duration of morning stiffness. The BASDAI score was obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 \[severity of morning stiffness\] and 6 \[duration of morning stiffness\]) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The BASDAI total score ranged from 0 to 10, where higher scores indicated more severe disease activity. The reported values were converted to cm for analysis.

Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) :Last Observation Carried Forward (LOCF): Period 2Period 2 baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64

50% improvement from baseline in BASDAI: percentage of participants who achieved 50% decrease from baseline in their BASDAI total score. BASDAI consisted: 6 questions (Q) related to disease activity. Each of first 5 questions was scored by participant on 100 mm scale, range 0=none to 100=very severe, higher scores = more severe disease activity. Sixth question: duration of morning stiffness, was on scale for 0=0 hours to 100=2 hours, higher scores = larger duration of morning stiffness. BASDAI score obtained by computing mean score for 2 questions related to morning stiffness (Q5 \[severity of morning stiffness\], Q6 \[duration of morning stiffness\]) and adding that value to sum of scores for first 4Q and then dividing total by 5. BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. BASDAI total score ranged from 0 to 10, higher scores = more severe disease activity. Reported values were converted to cm for analysis. The improvement was relative to period 2 baseline(last visit before treatment withdrawal).

Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64

Change from baseline in hsCRP levels were reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation.

Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 1Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24

Change from baseline in hsCRP levels were reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation.

Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64

Change from baseline in hsCRP levels were reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation.

Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Last Observation Carried Forward (LOCF): Period 1Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24

BASDAI consisted of 6 questions related to disease activity. Each of the first 5 questions was scored by the participant on a 100 mm scale ranging from 0 (none) to 100 (very severe), where higher scores indicated more severe disease activity. The sixth question, related to duration of morning stiffness measured on a scale for 0 (0 hours) to 100 (2 hours), where higher scores indicated larger duration of morning stiffness. The BASDAI score was obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 \[severity of morning stiffness\] and 6 \[duration of morning stiffness\]) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The BASDAI total score ranged from 0 to 10, where higher scores indicated more severe disease activity. The reported values were converted to cm for analysis.

Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score:Last Observation Carried Forward (LOCF): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64

BASDAI consisted of 6 questions related to disease activity. Each of the first 5 questions was scored by the participant on a 100 mm scale ranging from 0 (none) to 100 (very severe), where higher scores indicated more severe disease activity. The sixth question, related to duration of morning stiffness measured on a scale for 0 (0 hours) to 100 (2 hours), where higher scores indicated larger duration of morning stiffness. The BASDAI score was obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 \[severity of morning stiffness\] and 6 \[duration of morning stiffness\]) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The BASDAI total score ranged from 0 to 10, where higher scores indicated more severe disease activity. The reported values were converted to cm for analysis.

Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Observed Cases (OC): Period 3Period 3 baseline (last visit before retreatment), Week 64, 68, 72, 76

50% improvement from baseline in BASDAI: percentage of participants who achieved 50% decrease from baseline in their BASDAI total score. BASDAI consisted: 6 questions (Q) related to disease activity. Each of first 5 questions was scored by participant on 100 mm scale, range 0=none to 100=very severe, higher scores = more severe disease activity. Sixth question: duration of morning stiffness, was on scale for 0=0 hours to 100=2 hours, higher scores = larger duration of morning stiffness. BASDAI score was obtained by computing mean score for 2 questions related to morning stiffness (Q5 \[severity of morning stiffness\], Q6 \[duration of morning stiffness\]) and adding that value to sum of the scores for first 4Q and then dividing total by 5. BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. BASDAI total score ranged from 0 to 10, higher scores = more severe disease activity. Reported values were converted to cm for analysis. The improvement was relative to period 3 baseline (last visit before retreatment).

Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 32, 48, 64: Observed Cases (OC): Period 2Week 32, 48, 64

The EQ-5D questionnaire is a HRQOL. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a VAS with response options. Overall EQ 5D VAS score ranged from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. In this outcome measure, data for percentage of participants who reached the cut-off value of \> 82 is reported. This threshold was based on participant's demographic characteristics and population norm.

Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 32, 48, 64: Observed Cases (OC): Period 2Week 32, 48, 64

The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.

Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Observed Cases (OC): Period 1Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24

50% improvement from baseline in BASDAI: percentage of participants who achieved 50% decrease from baseline in their BASDAI total score. BASDAI consisted: 6 questions (Q) related to disease activity. Each of first 5 questions was scored by participant on 100 mm scale, range 0=none to 100=very severe, higher scores = more severe disease activity. Sixth question: duration of morning stiffness, was on scale for 0=0 hours to 100=2 hours, higher scores = larger duration of morning stiffness. BASDAI score was obtained by computing mean score for 2 questions related to morning stiffness (Q5 \[severity of morning stiffness\], Q6 \[duration of morning stiffness\]) and adding that value to sum of the scores for first 4Q and then dividing total by 5. BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. BASDAI total score ranged from 0 to 10, higher scores = more severe disease activity. Reported values were converted to cm for analysis. Improvement was relative to baseline (Day 1).

Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Observed Cases (OC): Period 2Period 2 baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64

50% improvement from baseline in BASDAI: percentage of participants who achieved 50% decrease from baseline in their BASDAI total score. BASDAI consisted: 6 questions (Q) related to disease activity. Each of first 5 questions was scored by participant on 100 mm scale, range 0=none to 100=very severe, higher scores = more severe disease activity. Sixth question: duration of morning stiffness, was on scale for 0=0 hours to 100=2 hours, higher scores = larger duration of morning stiffness. BASDAI score obtained by computing mean score for 2 questions related to morning stiffness (Q5 \[severity of morning stiffness\], Q6 \[duration of morning stiffness\]) and adding that value to sum of scores for first 4Q and then dividing total by 5. BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. BASDAI total score ranged from 0 to 10, higher scores = more severe disease activity. Reported values were converted to cm for analysis. The improvement was relative to period 2 baseline(last visit before treatment withdrawal).

Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) :Last Observation Carried Forward (LOCF): Period 3Period 3 baseline (last visit before retreatment), Week 64, 68, 72, 76

50% improvement from baseline in BASDAI: percentage of participants who achieved 50% decrease from baseline in their BASDAI total score. BASDAI consisted: 6 questions (Q) related to disease activity. Each of first 5 questions was scored by participant on 100 mm scale, range 0=none to 100=very severe, higher scores = more severe disease activity. Sixth question: duration of morning stiffness, was on scale for 0=0 hours to 100=2 hours, higher scores = larger duration of morning stiffness. BASDAI score was obtained by computing mean score for 2 questions related to morning stiffness (Q5 \[severity of morning stiffness\], Q6 \[duration of morning stiffness\]) and adding that value to sum of the scores for first 4Q and then dividing total by 5. BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. BASDAI total score ranged from 0 to 10, higher scores = more severe disease activity. Reported values were converted to cm for analysis. The improvement was relative to period 3 baseline (last visit before retreatment).

Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76

Change from baseline in hsCRP levels were reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation.

Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76

Change from baseline in hsCRP levels were reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation.

Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2Week 32, 48, 64

The EQ-5D questionnaire is a HRQOL. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a VAS with response options. Overall EQ 5D VAS score ranged from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. In this outcome measure, data for percentage of participants who reached the cut-off value of \> 82 is reported. This threshold was based on participant's demographic characteristics and population norm.

Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3Week 64, 76

The EQ-5D questionnaire is a HRQOL. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a VAS with response options. Overall EQ 5D VAS score ranged from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. In this outcome measure, data for percentage of participants who reached the cut-off value of \> 82 is reported. This threshold was based on participant's demographic characteristics and population norm.

Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3Week 64, 76

The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.

Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 12, 24: Observed Cases (OC): Period 1Baseline (Day 1 Week 1), Week 12, 24

The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.

Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 12, 24: Observed Cases (OC): Period 1Baseline (Day 1 Week 1), Week 12, 24

The EQ-5D questionnaire is a health-related quality of life assessment (HRQOL). The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a VAS with response options. Overall EQ 5D VAS score ranged from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. In this outcome measure, data for percentage of participants who reached the cut-off value of \> 82 is reported. This threshold was based on participant's demographic characteristics and population norm. The outcome measure was planned to be analyzed at baseline, Week 12 and 24.

Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1Baseline (Day 1 Week 1), Week 12, 24

The EQ-5D questionnaire is a HRQOL. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a VAS with response options. Overall EQ 5D VAS score ranged from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. In this outcome measure, data for percentage of participants who reached the cut-off value of \> 82 is reported. This threshold was based on participant's demographic characteristics and population norm. This outcome measure was planned to be analyzed at baseline, Week 12 and 24.

Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 12, 24: Observed Cases (OC): Period 1Week 12, 24

The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''. This outcome measure was planned to be analyzed at baseline, Week 12 and 24.

Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Observed Cases (OC): Period 1Baseline (Day 1 Week 1), Week 12, 24

The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''. This outcome measure was planned to be analyzed at baseline, Week 12 and 24.

Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1Baseline (Day 1 Week 1), Week 12, 24

The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''. This outcome measure was planned to be analyzed at baseline, Week 12 and 24.

Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2Week 32, 48, 64

The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.

Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 64, 76: Observed Cases (OC): Period 3Week 64, 76

The EQ-5D questionnaire is a HRQOL. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a VAS with response options. Overall EQ 5D VAS score ranged from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. In this outcome measure, data for percentage of participants who reached the cut-off value of \> 82 is reported. This threshold was based on participant's demographic characteristics and population norm.

Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 64, 76: Observed Cases (OC): Period 3Week 64, 76

The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.

Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2Week 32, 48, 64

The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.

Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3Week 64, 76

The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.

Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64

The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.

Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76

The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.

Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 12, 24: Observed Cases (OC): Period 1Baseline (Day 1 Week 1), Week 12, 24

SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores (physical component scores \[PCS\]; mental component scores \[MCS\]). Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).

Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1Week 12, 24

The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''. This outcome measure was planned to be analyzed at baseline, Week 12 and 24.

Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Observed Cases (OC): Period 2Week 32, 48, 64

The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.

Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 64, 76: Observed Cases (OC): Period 3Week 64, 76

The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.

Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 12, 24: Period 1Baseline (Day 1 Week 1), Week 12, 24

SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). The improvement was relative to baseline (Day 1).

Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 64, 76: Period 3Period 3 baseline (last visit before retreatment), Week 64, 76

SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to period 3 baseline (last visit before retreatment).

Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 32, 48, 64: Observed Cases (OC): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64

The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.

Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 64, 76: Observed Cases (OC): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76

SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).

Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) Week 12, 24: Last Observation Carried Forward (LOCF): Period 1Baseline (Day 1 Week 1), Week 12, 24

SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).

Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76

SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).

Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Period 2Period 2 baseline (last visit before treatment withdrawal), Week 32, 48, 64

SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to period 2 baseline (last visit before treatment withdrawal).

Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 32, 48, 64: Period 2Period 2 baseline (last visit before treatment withdrawal), Week 32, 48, 64

SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to period 2 baseline (last visit before treatment withdrawal).

Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 12, 24: Period 1Baseline (Day 1 Week 1), Week 12, 24

SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). The improvement was relative to baseline (Day 1).

Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1Baseline (Day 1 Week 1), Week 12, 24

SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).

Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Period 2Period 2 baseline (last visit before treatment withdrawal), Week 32, 48, 64

SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to period 2 baseline (last visit before treatment withdrawal).

Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 64, 76: Observed Cases (OC): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76

The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.

Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1Baseline (Day 1 Week 1), Week 12, 24

The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.

Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 32, 48, 64: Observed Cases (OC): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64

SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).

Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76

SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).

Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 64, 76: Period 3Period 3 baseline (last visit before retreatment), Week 64, 76

SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to period 3 baseline (last visit before retreatment).

Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64

SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).

Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 32, 48, 64: Period 2Period 2 baseline (last visit before treatment withdrawal), Week 32, 48, 64

SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to period 2 baseline (last visit before treatment withdrawal).

Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 12, 24: Period 1Baseline (Day 1 Week 1), Week 12, 24

SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to baseline (Day 1).

Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Period 3Period 3 baseline (last visit before retreatment), Week 64, 76

SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to period 3 baseline (last visit before retreatment).

Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 12, 24: Period 1Baseline (Day 1 Week 1), Week 12, 24

SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). The improvement was relative to baseline (Day 1).

Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 12, 24: Observed Cases (OC): Period 1Baseline (Day 1 Week 1), Week 12, 24

SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).

Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Observed Cases (OC): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64

SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).

Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 1Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem here "ankylosing spondylitis (AS)" affected work attendance, work productivity and productivity in non-work regular activities. Participants were asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity.

Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem here "AS" affected work attendance, work productivity and productivity in non-work regular activities. Participants were asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity.

Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 1Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem here "AS" affected work attendance, work productivity and productivity in non-work regular activities. Participants were asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity.

Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Observed Cases (OC): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76

SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).

Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64

SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).

Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76

Change from baseline in MRI score of spine was assessed using SPARCC method. Scoring was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned score of 0=no lesion or 1=increased signal. This part of coring allows for total score ranging from 0-8 for the 2 joints of one coronal slice. For each slice, score was increased by 1 for each joint that exhibits an intense signal in any quadrant (thereby allowing for an increase of up to 2 points in total score for each slice). Also, for each slice, an additional score of 1 was given for each joint that includes a lesion demonstrating continuous increased signal of depth \>=1 cm from articular surface (thereby allowing for an additional increase of up to 2 points for each slice). The total minimum and maximum score for all joints across 6 slices was 0 to 72 where higher scores reflecting worse disease.

Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 1Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24

Participants assessed their overall disease activity over the last 48 hours by using a 100 mm pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.

Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64

Participants assessed their overall disease activity over the last 48 hours by using a 100 mm pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.

Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76

Participants assessed their overall disease activity over the last 48 hours by using a 100 mm pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.

Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76

The physician assessed the overall disease activity of participants over the last 48 hours by using a 100 mm VAS pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.

Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Period 3Period 3 baseline (last visit before retreatment), Week 64, 76

SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to period 3 baseline (last visit before retreatment).

Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64

The physician assessed the overall disease activity of participants over the last 48 hours by using a 100 mm VAS pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.

Change From Baseline in Number of Swollen Joint Count at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64

Number of swollen joints was determined by examination of 44 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling =0, swelling =1.

Change From Baseline in Number of Tender Joint Count at Week 32, 48, 64: Observed Cases (OC): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64

Number of tender joints was determined by examining 44 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.

Change From Baseline in Number of Tender Joint Count at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1Baseline (Day 1 Week 1), Week 12, 24

Number of tender joints was determined by examining 44 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.

Change From Baseline in Dactylitis Total Score at Week 32, 48, 64: Observed Cases (OC): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64

Dactylitis is the inflammation of finger and/or toe joints (digits). Dactylitis scores was calculated by evaluating each of the 10 fingers and 10 toes. Each digit was evaluated on a 4-point scale ranging from of 0 to 3 where 0 = none, 1= mild, 2 = moderate, 3 = severe inflammation. The total score was calculated as the sum of scores for the 20 digits, total score ranged from 0 to 60, where higher scores indicated severe inflammation.

Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 32, 48, 64: Observed Cases (OC): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64

The MASES is an index used to measure the severity of enthesitis. Enthesitis is the inflammation of enthuses (heels). The MASES assesses 13 sites for enthesitis. Each site is scored as 0 or 1 depending on whether enthesitis is present or absent. Sites assessed include 1st costochondral joint (left/right), 7 th costochondral joint (l/r), posterior superior iliac spine (l/r), posterior anterior iliac spine (l/r), iliac crest (l/r), proximal insertion of Achilles tendon (l/r) and 5th lumbar spinous process. The MASES is the sum of all site scores range from 0 (no inflammation) to 13 (worst possible inflammation) where higher scores indicate more severe inflammation of entheses.

Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem here "AS" affected work attendance, work productivity and productivity in non-work regular activities. Participants were asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity.

Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem here "AS" affected work attendance, work productivity and productivity in non-work regular activities. Participants were asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity.

Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem here "AS" affected work attendance, work productivity and productivity in non-work regular activities. Participants were asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity.

Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 24: Last Observation Carried Forward (LOCF): Period 1Baseline (Day 1 Week 1), Week 24

Change from baseline in MRI score of spine was assessed using SPARCC method. Scoring was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned score of 0=no lesion or 1=increased signal. This part of coring allows for total score ranging from 0-8 for the 2 joints of one coronal slice. For each slice, score was increased by 1 for each joint that exhibits an intense signal in any quadrant (thereby allowing for an increase of up to 2 points in total score for each slice). Also, for each slice, an additional score of 1 was given for each joint that includes a lesion demonstrating continuous increased signal of depth \>=1 cm from articular surface (thereby allowing for an additional increase of up to 2 points for each slice). The total minimum and maximum score for all joints across 6 slices was 0 to 72 where higher scores reflecting worse disease.

Change From Baseline in Number of Swollen Joint Count at Week 32, 48, 64: Observed Cases (OC): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64

Number of swollen joints was determined by examination of 44 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling =0, swelling =1.

Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 48, 64: Last Observation Carried Forward (LOCF): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 48, 64

Change from baseline in MRI score of spine was assessed using SPARCC method. Scoring was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned score of 0=no lesion or 1=increased signal. This part of coring allows for total score ranging from 0-8 for the 2 joints of one coronal slice. For each slice, score was increased by 1 for each joint that exhibits an intense signal in any quadrant (thereby allowing for an increase of up to 2 points in total score for each slice). Also, for each slice, an additional score of 1 was given for each joint that includes a lesion demonstrating continuous increased signal of depth \>=1 cm from articular surface (thereby allowing for an additional increase of up to 2 points for each slice). The total minimum and maximum score for all joints across 6 slices was 0 to 72 where higher scores reflecting worse disease.

Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 24: Observed Cases (OC): Period 1Baseline (Day 1 Week 1), Week 24

Change from baseline in MRI score of spine was assessed using SPARCC method. Scoring was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned score of 0=no lesion or 1=increased signal. This part of coring allows for total score ranging from 0-8 for the 2 joints of one coronal slice. For each slice, score was increased by 1 for each joint that exhibits an intense signal in any quadrant (thereby allowing for an increase of up to 2 points in total score for each slice). Also, for each slice, an additional score of 1 was given for each joint that includes a lesion demonstrating continuous increased signal of depth \>=1 cm from articular surface (thereby allowing for an additional increase of up to 2 points for each slice). The total minimum and maximum score for all joints across 6 slices was 0 to 72 where higher scores reflecting worse disease.

Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 48, 64: Observed Cases (OC): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 48, 64

Change from baseline in MRI score of spine was assessed using SPARCC method. Scoring was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned score of 0=no lesion or 1=increased signal. This part of coring allows for total score ranging from 0-8 for the 2 joints of one coronal slice. For each slice, score was increased by 1 for each joint that exhibits an intense signal in any quadrant (thereby allowing for an increase of up to 2 points in total score for each slice). Also, for each slice, an additional score of 1 was given for each joint that includes a lesion demonstrating continuous increased signal of depth \>=1 cm from articular surface (thereby allowing for an additional increase of up to 2 points for each slice). The total minimum and maximum score for all joints across 6 slices was 0 to 72 where higher scores reflecting worse disease.

Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 64, 76: Observed Cases (OC): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76

Change from baseline in MRI score of spine was assessed using SPARCC method. Scoring was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned score of 0=no lesion or 1=increased signal. This part of coring allows for total score ranging from 0-8 for the 2 joints of one coronal slice. For each slice, score was increased by 1 for each joint that exhibits an intense signal in any quadrant (thereby allowing for an increase of up to 2 points in total score for each slice). Also, for each slice, an additional score of 1 was given for each joint that includes a lesion demonstrating continuous increased signal of depth \>=1 cm from articular surface (thereby allowing for an additional increase of up to 2 points for each slice). The total minimum and maximum score for all joints across 6 slices was 0 to 72 where higher scores reflecting worse disease.

Time to Ankylosing Spondylitis Disease Activity Score (ASDAS) Inactive Disease After Re-treatment in Period 3Within 12 weeks of Period 3 (retreatment period from Week 64 to 76)

Time to ASDAS inactive disease was defined as the time from first dose of retreatment until the first observed event of ASDAS inactive disease. Inactive disease is defined as an ASDAS score \<1.3. for ASDAS-CRP or ASDAS score of \>=2.1 for ASDAS-ESR. Participants who did not achieve ASDAS inactive disease were censored at the time of the last ASDAS evaluation in the interval.

Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 1Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24

Participants assessed their overall disease activity over the last 48 hours by using a 100 mm pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.

Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64

Participants assessed their overall disease activity over the last 48 hours by using a 100 mm pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.

Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 1Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24

The physician assessed the overall disease activity of participants over the last 48 hours by using a 100 mm VAS pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.

Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76

The BAS-G was a 2-question assessment evaluating the effect of AS on the participants well-being over the last week and last 6 months. Each question scored by the participant on a 100 mm VAS scale ranging from 0 (very Good) to 100 (very Bad), where higher scores indicated worse health condition. The total BAS-G score calculated as the average scores of these two questions and then converted into cm for analysis. Total BAS-G score ranged from 0 to 10 cm, where higher scores indicated worse health condition.

Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 12, 24: Observed Cases (OC): Period 1Baseline (Day 1 Week 1), Week 12, 24

The BAS-G was a 2-question assessment evaluating the effect of AS on the participants well-being over the last week and last 6 months. Each question scored by the participant on a 100 mm VAS scale ranging from 0 (very Good) to 100 (very Bad), where higher scores indicated worse health condition. The total BAS-G score calculated as the average scores of these two questions and then converted into cm for analysis. Total BAS-G score ranged from 0 to 10 cm, where higher scores indicated worse health condition.

Change From Baseline in Number of Tender Joint Count at Week 64, 76: : Observed Cases (OC): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76

Number of tender joints was determined by examining 44 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.

Change From Baseline in Dactylitis Total Score at Week 64, 76: Observed Cases (OC): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76

Dactylitis is the inflammation of finger and/or toe joints (digits). Dactylitis scores was calculated by evaluating each of the 10 fingers and 10 toes. Each digit was evaluated on a 4-point scale ranging from of 0 to 3 where 0 = none, 1= mild, 2 = moderate, 3 = severe inflammation. The total score was calculated as the sum of scores for the 20 digits, total score ranged from 0 to 60, where higher scores indicated severe inflammation.

Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76

Participants assessed their overall disease activity over the last 48 hours by using a 100 mm pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.

Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score) at Week 32, 48, 64: Observed Cases (OC): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64

The BAS-G was a 2-question assessment evaluating the effect of AS on the participants well-being over the last week and last 6 months. Each question scored by the participant on a 100 mm VAS scale ranging from 0 (very Good) to 100 (very Bad), where higher scores indicated worse health condition. The total BAS-G score calculated as the average scores of these two questions and then converted into cm for analysis. Total BAS-G score ranged from 0 to 10 cm, where higher scores indicated worse health condition.

Change From Baseline in Number of Swollen Joint Count at Week 12, 24: Observed Cases (OC): Period 1Baseline (Day 1 Week 1), Week 12, 24

Number of swollen joints was determined by examination of 44 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling =0, swelling =1.

Change From Baseline in Dactylitis Total Score at Week 12, 24: Observed Cases (OC): Period 1Baseline (Day 1 Week 1), Week 12, 24

Dactylitis is the inflammation of finger and/or toe joints (digits). Dactylitis scores was calculated by evaluating each of the 10 fingers and 10 toes. Each digit was evaluated on a 4-point scale ranging from of 0 to 3 where 0 = none, 1= mild, 2 = moderate, 3 = severe inflammation. The total score was calculated as the sum of scores for the 20 digits, total score ranged from 0 to 60, where higher scores indicated severe inflammation.

Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 1Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24

The physician assessed the overall disease activity of participants over the last 48 hours by using a 100 mm VAS pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.

Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64

The physician assessed the overall disease activity of participants over the last 48 hours by using a 100 mm VAS pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.

Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76

The physician assessed the overall disease activity of participants over the last 48 hours by using a 100 mm VAS pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.

Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1Baseline (Day 1 Week 1), Week 12, 24

The BAS-G was a 2-question assessment evaluating the effect of AS on the participants well-being over the last week and last 6 months. Each question scored by the participant on a 100 mm VAS scale ranging from 0 (very Good) to 100 (very Bad), where higher scores indicated worse health condition. The total BAS-G score calculated as the average scores of these two questions and then converted into cm for analysis. Total BAS-G score ranged from 0 to 10 cm, where higher scores indicated worse health condition.

Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64

The BAS-G was a 2-question assessment evaluating the effect of AS on the participants well-being over the last week and last 6 months. Each question scored by the participant on a 100 mm VAS scale ranging from 0 (very Good) to 100 (very Bad), where higher scores indicated worse health condition. The total BAS-G score calculated as the average scores of these two questions and then converted into cm for analysis. Total BAS-G score ranged from 0 to 10 cm, where higher scores indicated worse health condition.

Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 64, 76: Observed Cases (OC): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76

The BAS-G was a 2-question assessment evaluating the effect of AS on the participants well-being over the last week and last 6 months. Each question scored by the participant on a 100 mm VAS scale ranging from 0 (very Good) to 100 (very Bad), where higher scores indicated worse health condition. The total BAS-G score calculated as the average scores of these two questions and then converted into cm for analysis. Total BAS-G score ranged from 0 to 10 cm, where higher scores indicated worse health condition.

Change From Baseline in Number of Swollen Joint Count at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1Baseline (Day 1 Week 1), Week 12, 24

Number of swollen joints was determined by examination of 44 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling =0, swelling =1.

Change From Baseline in Number of Swollen Joint Count at Week 64, 76 : Last Observation Carried Forward (LOCF): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76

Number of swollen joints was determined by examination of 44 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling =0, swelling =1.

Change From Baseline in Number of Swollen Joint Count at Week 64, 76: Observed Cases (OC): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76

Number of swollen joints was determined by examination of 44 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling =0, swelling =1.

Change From Baseline in Number of Tender Joint Count at Week 12, 24: Observed Cases (OC): Period 1Baseline (Day 1 Week 1), Week 12, 24

Number of tender joints was determined by examining 44 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.

Change From Baseline in Number of Tender Joint Count at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64

Number of tender joints was determined by examining 44 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.

Change From Baseline in Number of Tender Joint Count at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76

Number of tender joints was determined by examining 44 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.

Change From Baseline in Dactylitis Total Score at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1Baseline (Day 1 Week 1), Week 12, 24

Dactylitis is the inflammation of finger and/or toe joints (digits). Dactylitis scores was calculated by evaluating each of the 10 fingers and 10 toes. Each digit was evaluated on a 4-point scale ranging from of 0 to 3 where 0 = none, 1= mild, 2 = moderate, 3 = severe inflammation. The total score was calculated as the sum of scores for the 20 digits, total score ranged from 0 to 60, where higher scores indicated severe inflammation.

Change From Baseline in Dactylitis Total Score at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64

Dactylitis is the inflammation of finger and/or toe joints (digits). Dactylitis scores was calculated by evaluating each of the 10 fingers and 10 toes. Each digit was evaluated on a 4-point scale ranging from of 0 to 3 where 0 = none, 1= mild, 2 = moderate, 3 = severe inflammation. The total score was calculated as the sum of scores for the 20 digits, total score ranged from 0 to 60, where higher scores indicated severe inflammation.

Change From Baseline in Dactylitis Total Score at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76

Dactylitis is the inflammation of finger and/or toe joints (digits). Dactylitis scores was calculated by evaluating each of the 10 fingers and 10 toes. Each digit was evaluated on a 4-point scale ranging from of 0 to 3 where 0 = none, 1= mild, 2 = moderate, 3 = severe inflammation. The total score was calculated as the sum of scores for the 20 digits, total score ranged from 0 to 60, where higher scores indicated severe inflammation.

Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12, 24: Observed Cases (OC) : Period 1Baseline (Day 1 Week 1), Week 12, 24

The MASES is an index used to measure the severity of enthesitis. Enthesitis is the inflammation of enthuses (heels). The MASES assesses 13 sites for enthesitis. Each site is scored as 0 or 1 depending on whether enthesitis is present or absent. Sites assessed include 1st costochondral joint (left/right), 7 th costochondral joint (l/r), posterior superior iliac spine (l/r), posterior anterior iliac spine (l/r), iliac crest (l/r), proximal insertion of Achilles tendon (l/r) and 5th lumbar spinous process. The MASES is the sum of all site scores range from 0 (no inflammation) to 13 (worst possible inflammation) where higher scores indicate more severe inflammation of entheses.

Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2Period 1 Baseline (Day 1 Week 1), Period 2: Baseline (last visit before treatment withdrawal), Week 32, 48, 64

The MASES is an index used to measure the severity of enthesitis. Enthesitis is the inflammation of enthuses (heels). The MASES assesses 13 sites for enthesitis. Each site is scored as 0 or 1 depending on whether enthesitis is present or absent. Sites assessed include 1st costochondral joint (left/right), 7 th costochondral joint (l/r), posterior superior iliac spine (l/r), posterior anterior iliac spine (l/r), iliac crest (l/r), proximal insertion of Achilles tendon (l/r) and 5th lumbar spinous process. The MASES is the sum of all site scores range from 0 (no inflammation) to 13 (worst possible inflammation) where higher scores indicate more severe inflammation of entheses.

Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 64, 76: Observed Cases (OC): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76

The MASES is an index used to measure the severity of enthesitis. Enthesitis is the inflammation of enthuses (heels). The MASES assesses 13 sites for enthesitis. Each site is scored as 0 or 1 depending on whether enthesitis is present or absent. Sites assessed include 1st costochondral joint (left/right), 7 th costochondral joint (l/r), posterior superior iliac spine (l/r), posterior anterior iliac spine (l/r), iliac crest (l/r), proximal insertion of Achilles tendon (l/r) and 5th lumbar spinous process. The MASES is the sum of all site scores range from 0 (no inflammation) to 13 (worst possible inflammation) where higher scores indicate more severe inflammation of entheses.

Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76

The MASES is an index used to measure the severity of enthesitis. Enthesitis is the inflammation of enthuses (heels). The MASES assesses 13 sites for enthesitis. Each site is scored as 0 or 1 depending on whether enthesitis is present or absent. Sites assessed include 1st costochondral joint (left/right), 7 th costochondral joint (l/r), posterior superior iliac spine (l/r), posterior anterior iliac spine (l/r), iliac crest (l/r), proximal insertion of Achilles tendon (l/r) and 5th lumbar spinous process. The MASES is the sum of all site scores range from 0 (no inflammation) to 13 (worst possible inflammation) where higher scores indicate more severe inflammation of entheses.

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. Treatment-emergent were events between first dose of investigational product and up to 28 days after the last dose of investigational product that were absent before treatment or that worsened relative to pretreatment state.

Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1Baseline (Day 1 Week 1), Week 12, 24

The MASES is an index used to measure the severity of enthesitis. Enthesitis is the inflammation of enthuses (heels). The MASES assesses 13 sites for enthesitis. Each site is scored as 0 or 1 depending on whether enthesitis is present or absent. Sites assessed include 1st costochondral joint (left/right), 7 th costochondral joint (l/r), posterior superior iliac spine (l/r), posterior anterior iliac spine (l/r), iliac crest (l/r), proximal insertion of Achilles tendon (l/r) and 5th lumbar spinous process. The MASES is the sum of all site scores range from 0 (no inflammation) to 13 (worst possible inflammation) where higher scores indicate more severe inflammation of entheses.

Trial Locations

Locations (80)

Genesis Research Services Pty Ltd

🇦🇺

Broadmeadow, New South Wales, Australia

Hunter Imaging Group

🇦🇺

Cardiff, New South Wales, Australia

Winthrop University Hospital, Clinical Trials Center

🇺🇸

Mineola, New York, United States

Pacific Radiology

🇦🇺

Maroochydore, Queensland, Australia

Skanes University Hospital Malmo

🇸🇪

Malmo, Sweden

Complejo Hospitalario Regional Virgen Macarena

🇪🇸

Sevilla, Spain

Nasz Lekarz Przychodnie Medyczne

🇵🇱

Torun, Poland

Akademiska sjukhuset

🇸🇪

Uppsala, Sweden

Praxis für radiologische Diagnostik

🇩🇪

Berlin, Germany

Mvz Agilomed

🇩🇪

Chemnitz, Germany

Complejo Hospitalario Universitario Santiago

🇪🇸

Santiago de Compostela, A Coruna, Spain

HYKS, Meilahden kolmiosairaala

🇫🇮

Helsinki, Finland

Lekarna Hradebni s.r.o.

🇨🇿

Uherske Hradiste, Czechia

Hopital Cochin Pavillon Hardy B4

🇫🇷

Paris, France

Pharmacie Essais cliniques

🇫🇷

Vandoeuvre les Nancy, France

Gulf Region Clinical Research Institute

🇺🇸

Pensacola, Florida, United States

Zaklad Radiologii i Diagnostyki Obrazowej

🇵🇱

Bydgoszcz, Poland

Charité Universitaetsmedizin Berlin

🇩🇪

Berlin, Germany

Rheumatologische Schwerpunktpraxis

🇩🇪

Berlin, Germany

CHU de Rennes, Hopital Sud

🇫🇷

Rennes, France

SANUS Szpital Specjalistyczny Sp. z o.o.

🇵🇱

Stalowa Wola, Poland

Medycyna Kliniczna

🇵🇱

Warszawa, Poland

READE

🇳🇱

Amsterdam, Netherlands

Affidea Praha s.r.o.

🇨🇿

Praha 11, Czechia

Revmatologicky ustav

🇨🇿

Praha 2, Czechia

Service d'Imagerie Guilloz

🇫🇷

Nancy, France

Medizinische Klinik und Poliklinik IV

🇩🇪

Muenchen, Bavaria, Germany

Universitaetskliniken Koeln

🇩🇪

Koeln, Germany

MEDICAL PLUS, s.r.o.

🇨🇿

Uherske Hradiste, Czechia

Uherskohradist' ska nemocnice a.s.

🇨🇿

Uherske Hradiste, Czechia

Rheumazentrum Ruhrgebiet

🇩🇪

Herne, NRW, Germany

Pharmacie-Secteur Essais cliniques

🇫🇷

Paris, France

Helsinki University Hospital

🇫🇮

Helsinki, Finland

Sahlgrenska University Hospital

🇸🇪

Gothenburg, Sweden

Reumed Sp z.o.o. Zespool Poradni Specjalistycznych Filia nr 1

🇵🇱

Lublin, Poland

RCMed

🇵🇱

Sochaczew, Poland

Diagnostic-Med Centrum Diagnostyki Radiologicznej

🇵🇱

Poznan, Poland

Hospital San Rafael

🇪🇸

La Coruna, Spain

Complexo Hospitalario Universitario A Coruna

🇪🇸

La Coruna, Spain

China Medical University Hospital

🇨🇳

Taichung, Taiwan

Altoona Center for Clinical Research

🇺🇸

Duncansville, Pennsylvania, United States

Penn State Milton S. Hershey Medical Center

🇺🇸

Hershey, Pennsylvania, United States

Private Practice Rheumatology

🇧🇪

Sint-Niklaas, OVL, Belgium

Rheumatology Research Centre

🇦🇺

Maroochydore, Queensland, Australia

The Queen Elizabeth Hospital

🇦🇺

Woodville South, South Australia, Australia

SKG Radiology Hollywood Hospital

🇦🇺

Nedlands, Western Australia, Australia

Reumaclinic

🇧🇪

Genk, Belgium

Preventive Care SAS

🇨🇴

Chía, Cundinamarca, Colombia

CHU de Nancy - Hopital de Brabois

🇫🇷

Vandoeuvre-les-Nancy cedex, France

Centrum Kliniczno-Badawcze J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska

🇵🇱

Elblag, Poland

LUMC

🇳🇱

Leiden, Netherlands

R.K. Will Pty Ltd

🇦🇺

Victoria Park, Western Australia, Australia

Hospital Universitario de Canarias

🇪🇸

San Cristobal de la Laguna, Santa CRUZ DE Tenerife, Spain

SKG Radiology Subiaco

🇦🇺

Subiaco, Western Australia, Australia

Northwestern Medical Group; Division of Rheumatology

🇺🇸

Chicago, Illinois, United States

Northwestern Memorial Hospital

🇺🇸

Chicago, Illinois, United States

Seattle Rheumatology Associates

🇺🇸

Seattle, Washington, United States

Northwestern University Clinical and Translational Sciences Institute (NUCATS)

🇺🇸

Chicago, Illinois, United States

Oregon Health and Science University Research Pharmacy

🇺🇸

Portland, Oregon, United States

Oregon Health and Science University

🇺🇸

Portland, Oregon, United States

Swedish Medical Center Investigational Drug Services Pharmacy

🇺🇸

Seattle, Washington, United States

CHU PURPAN, Hopital Pierre-Paul Riquet

🇫🇷

Toulouse cedex 9, France

Pharmacie

🇫🇷

Toulouse cedex 9, France

Schlosspark-Klinik GmbH

🇩🇪

Berlin, Germany

Swedish Medical Center

🇺🇸

Seattle, Washington, United States

Apotheke am Tierpark

🇩🇪

Berlin, Germany

Benson Radiology

🇦🇺

North Adelaide, South Australia, Australia

Kaohsiung Medical University Hospital

🇨🇳

Kaohsiung, Taiwan

Centro Integral de Reumatologia Reumalab S.A.S.

🇨🇴

Medellin, Antioquia, Colombia

VITAL MEDICAL CENTER Orvosi es Fogorvosi Kozpont

🇭🇺

Veszprem, Hungary

Szpital Uniwersytecki nr 2 im. dr J. Biziela w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorob

🇵🇱

Bydgoszcz, Poland

Hospital Pablo Tobon Uribe

🇨🇴

Medellin, Antioquia, Colombia

Nzoz McD Voxel

🇵🇱

Bydgoszcz, Poland

Samodzielny Publiczny Zespol Opieki Zdrowotnej

🇵🇱

Koscian, Poland

Reumatika-Centrum Reumatologii NZOZ

🇵🇱

Warszawa, Poland

Kiljavan Laaketutkimus Oy

🇫🇮

Hyvinkaa, Finland

Chung Shan Medical University Hospital

🇨🇳

Taichung, Taiwan

Qualiclinic Kft.

🇭🇺

Budapest, Hungary

Centrum Medyczne OPOROW

🇵🇱

Wrocław, Poland

Chung Shan Medical University

🇨🇳

Taichung, Taiwan

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