A Study To Evaluate The Efficacy Of Enbrel (REGISTERED) Etanercept Over A Period Of 12 Months In The Routine Treatment Of Patients With Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriatic Arthritis, Or Plaque Psoriasis.
- Conditions
- Psoriatic ArthritisRheumatoid ArthritisPlaque PsoriasisAxial Spondyloarthritis
- Interventions
- Registration Number
- NCT02486302
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this non-interventional study is to evaluate the efficacy of etanercept during routine clinical use over a maximum of 12 months in patients with rheumatoid arthritis (RA), psoriatic arthritis(PsA), axial spondyloarthritis(axSpA) or plaque psoriasis (PsO). In so doing, particular attention will be paid to the proportion of those patients who only attain the desired treatment goal after 12 weeks of treatment. The primary efficacy end point for the study is the proportion of patients who attain the desired treatment goal after 12 and 24 weeks,
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1534
- Confirmed diagnosis of RA, axSpA, PsA or PsO
- No prior treatment with etanercept and eligibility for treatment with etanercept according to the summary of product characteristics.
- The contraindications, special warnings, and precautions according to the summary of product characteristics for etanercept shall apply.
- The additional documentation of the patient in another post-marketing study with etanercept is not permitted.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Observation Group Etanercept -
- Primary Outcome Measures
Name Time Method Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 Week 12 Disease activity score based on 28-joints count (DAS28) calculated as weighted average of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour \[mm/h\]) and patient's global assessment (PtGA) of disease activity (recorded on a visual analog scale \[VAS\] scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28 \<2.6 = remission, DAS28 less than or equal to (\<=) 3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 Week 24 DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR \[mm/h\] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 and Maintained Till 52 Weeks Week 12 up to Week 52 DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR \[mm/h\] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 and Maintained Till 52 Weeks Week 24 up to Week 52 DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR \[mm/h\] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
Number of Participants With PsO Who Achieved 75% Improvement From Baseline in Psoriasis Area & Severity Index(PASI75) Score or Physician's Global Assessment(PGA) of Clear or Almost Clear And Dermatology Life Quality Index(DLQI) Total Score of 0 or 1 Week 12 PASI:combined assessment of lesion severity \& area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored \& scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) \& severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:\>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear \& almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect).
Number of Participants With Axial Spondyloarthritis (axSpA) Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 12 Week 12 ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 \<= ASDAS \< 1.3; moderate disease activity: 1.3 \<= ASDAS \< 2.1; high disease activity: 2.1 \<= ASDAS \<= 3.5; very high disease activity: 3.5 \< ASDAS.
Number of Participants With Psoriatic Arthritis (PsA) Who Achieved Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 12 Week 12 DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC \<=1; 2) SJC =\<1; 3) PASI \<= 1 or body surface area (BSA) \<=3; 4) Participant pain on VAS \<= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain \[best\] and 100 mm = maximum possible pain \[worst\]; 5) PtGA on VAS \<= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) Health assessment questionnaire disability index (HAQ-DI) \<= 0.5(HAQ=3.16-\[0.028\* hannover functional questionnaire \[FFbH\]); 7) Tender enthesial points \<= 1.
Number of Participants With Plaque Psoriasis (PsO) Who Achieved 75% Improvement in Psoriasis Area and Severity Index (PASI75) Score or a Physician's Global Assessment (PGA) of "Clear" or "Almost Clear" and DLQI Total Score of 0 or 1 at Week 24 Week 24 PASI:combined assessment of lesion severity \& area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored \& scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) \& severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:\>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear \& almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect).
Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 24 Week 24 ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 \<= ASDAS \< 1.3; moderate disease activity: 1.3 \<= ASDAS \< 2.1; high disease activity: 2.1 \<= ASDAS \<= 3.5; very high disease activity: 3.5 \< ASDAS.
Number of Participants With Psoriatic Arthritis (PsA) Achieving Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 24 Week 24 DAS28 calculated as average of SJC and TJC using the 28 joints count, ESR (mm/h) and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC t\<=1; 2) SJC =\<1; 3) PASI \<= 1 or BSA \<=3; 4) Participant pain on VAS \<= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain \[best\] and 100 mm = maximum possible pain \[worst\]; 5) PtGA on VAS \<= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) HAQ-DI \<= 0.5(HAQ=3.16-\[0.028\*FFbH); 7) Tender enthesial points \<= 1.
- Secondary Outcome Measures
Name Time Method Patient Health Quessionare-2 (PHQ-2) Scores at Weeks 12, 24, 36 and 52 Weeks 12, 24, 36, 52 The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia (inability to feel pleasure in normally pleasurable activities) over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 score ranged from 0-6 (0 indicate not at all: depression/anhedonia can be ruled out; 6 indicate nearly every day: worsening of depression/anhedonia).
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Weeks 12, 24, 36, 52 The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported.
Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Treated Set (TS) Baseline up to Weeks 12, 24, 36, 52 Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set Baseline up to Weeks 12, 24, 36, 52 Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to Weeks 12, 24, 36 and 52: Treated Set Baseline up to Weeks 12, 24, 36, 52 An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (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. TEAEs were measured up to Week 12, 24, 36 and 52 of exposure with study drug that were absent before treatment or that worsened relative to pretreatment state. TEAEs included both SAEs and non-SAEs.
Number of Participants With Treatment Emergent Adverse Events up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set Baseline up to Weeks 12, 24, 36, 52 An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A 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. TEAEs were measured up to Week 12, 24, 36 and 52 of exposure with study drug that were absent before treatment or that worsened relative to pretreatment state. TEAEs included both SAEs and non-SAEs.
Number of Participants Achieving 28 Joint Disease Activity Score (DAS28) Remission at Weeks 12, 24, 36 and 52 Weeks 12, 24, 36, 52 DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. Participants who had DAS28 \<= 2.6 were considered in remission.
Patient Global Assessment of Disease Activity (PtGA) Scores at Weeks 12, 24, 36 and 52 Weeks 12, 24, 36, 52 Participants answered question: "How do you assess your current disease activity?" Participants responded by using a 0 - 100 mm visual analog scale where 0 mm = no activity and 100 mm = highest possible activity.
Mean Visual Analogue Scale (VAS) Fatigue Scores at Weeks 12, 24, 36 and 52 Weeks 12, 24, 36, 52 Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.
Mean Visual Analogue Scale (VAS) Pain Scores at Weeks 12, 24, 36 and 52 Weeks 12, 24, 36, 52 Participants assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst).
Physician Global Assessment (PGA) of Disease Activity Scores at Weeks 12, 24, 36 and 52 Weeks 12, 24, 36, 52 PGA of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity; 100 mm= high disease activity.
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Weeks 12, 24, 36, 52 The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported.
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 Weeks 12, 24, 36, 52 FFbH consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores \* 100% \[percent\]) / (2 \* number of answered questions) ranged between 0-100; higher score indicates better daily activities. Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes \[24 hours\*60 minutes\] was recorded).
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Weeks 12, 24, 36, 52 The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported.
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Weeks 12, 24, 36, 52 The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported.
Psoriatic Arthritis(PsA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 Weeks 12, 24, 36, 52 FFbH consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores \* 100% \[percent\]) / (2 \* number of answered questions) ranged between 0-100; higher score indicates better daily activities. Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes \[24 hours\*60 minutes\] was recorded).
Ankylosing Spondylitis(axSpA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 Weeks 12, 24, 36, 52 FFbH consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores \* 100% \[percent\]) / (2 \* number of answered questions) ranged between 0-100; higher score indicates better daily activities. Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes \[24 hours\*60 minutes\] was recorded).
Percentage of Participants Who Discontinued Treatment Due to Lack of Efficacy or Adverse Events Baseline up to Week 52 Percentage of participants who discontinued etanercept before completing the study, was reported.
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Baseline up to Week 52 Participants who switched from etanercept to either disease-modifying antirheumatic drugs (DMARDs) or alternative biologic drug were reported.
Hannover Functional Questionnaire (FFbH) Functional Capacity Score of Participants With Rheumatoid Arthritis (RA), Axial Spondyloarthritis (axSpA), Psoriasis Arthritis (PsA) at Weeks 12, 24, 36, 52 Weeks 12, 24, 36, 52 FFbH consisted 18 questions to assess daily activities in last 7 days. Each question was answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores \* 100% \[percent\]) / (2 \* number of answered questions) ranged between 0-100; higher score indicated better daily activities.
Clinical Disease Activity Index (CDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52 Weeks 12, 24, 36, 52 The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity. CDAI total score = 0-76. CDAI \<= 2.8 indicates disease remission, \>2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high disease activity.
Simplified Disease Activity Index (SDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52 Weeks 12, 24, 36, 52 The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity, and C-reactive protein (CRP) (mg/dL). SDAI total score= 0-86. SDAI \<=3.3 indicates disease remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high disease activity.
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52 Weeks 12, 24, 36, 52 BASDAI is a validated self-assessment tool used to determine disease activity in participant with ankylosing spondylitis. Utilizing a VAS of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0(no symptoms)-10(very severe symptoms).
Number of Affected Enthesis in Participants With Axial Spondyloarthritis (axSpA) and Psoriatic Arthritis(PsA) at Weeks 12, 24, 36 and 52 Weeks 12, 24, 36, 52 An enthesis is the site where the joint capsules, ligaments or tendons attach to the bone. Enthesitis is the inflammation of the entheses. This inflammation can lead to severe pain and discomfort.
Occiput-to-wall Distance of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52 Weeks 12, 24, 36, 52 Occiput-to-wall distance was the distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.
Mean Percentage of Total Body Surface Area (BSA) for Participants With Plaque Psoriasis (PsO) and Psoriasis Arthritis (PsA) at Weeks 12, 24, 36 and 52 Weeks 12, 24, 36, 52 Percentage of BSA affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb = 1 percent (%) of total BSA. Regions of the body were assigned specific number of palms with percentage \[Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)\]. The total BSA affected was the summation of individual regions affected.
Mean of Total Number of Affected Fingers or Toes by Dactylitis in Participants With Psoriatic Arthritis (PsA) at Weeks 12, 24, 36 and 52 Weeks 12, 24, 36, 52 Each of the 10 fingers and 10 toes was evaluated for dactylitis. Score ranged from 0 to 20, where affected numbers of fingers and toes were evaluated.
Change From Baseline in Psoriasis Area and Severity Index (PASI) in Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 Baseline, Weeks 12, 24, 36, 52 Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% involvement to 6= 90-100% involvement. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section\*area score\*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease.
Median Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response in Participants With Plaque Psoriasis (PsO) Baseline up to Week 24 PASI: combined assessment of lesion severity \& area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself \& scores combined for final PASI. For each section % area of skin involved was estimated:0(0%) - 6(90-100%) \& severity estimated by clinical signs of erythema, induration, desquamation; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI75: at least a 75 % reduction in PASI relative to Baseline.
Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) Weeks 12, 24, 36, 52 PASI: combined assessment of lesion severity \& area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself \& scores combined for final PASI. For each section % area of skin involved was estimated:0(0%) - 6(90-100%) \& severity estimated by component score of erythema, induration, desquamation; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).
Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) Weeks 12, 24, 36, 52 PASI: combined assessment of lesion severity \& area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself \& scores combined for final PASI. For each section % area of skin involved was estimated:0(0%) - 6(90-100%) \& severity estimated by clinical signs of erythema, induration, desquamation; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).
Dermatology Life Quality Index (DLQI) Total Score for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 Weeks 12, 24, 36, 52 The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): no effect at DLQI \< 2; small effect at 2 \<=DLQI \<= 5; moderate effect at 6 \<=DLQI \<= 10; very large effect at 11\<=DLQI \<= 20; extremely large effect at 21 \<= DLQI \<= 30.
Patient Assessment of Pruritus for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 Weeks 12, 24, 36, 52 Participant's assessment of pruritus measured on a 100 mm VAS ranging from 0 as "no Pruritus" to 100 as "most severe pruritus".
Trial Locations
- Locations (180)
Rheumatologisches MVZ Dresden GmbH im Gesundheitszentrum Dresden - Klotzsche (GZDK)
🇩🇪Dresden, Sachsen, Germany
private practise Schmitt-Haendle
🇩🇪Bayreuth, Germany
private practise Hemmerich
🇩🇪Aachen, Germany
Gesundheits- und Pflegezentrum Alsfeld gGmbH
🇩🇪Alsfeld, Germany
Private Practise Marycz
🇩🇪Amberg, Germany
Klinikum Bad Bramstedt
🇩🇪Bad Bramstedt, Germany
private practise Kupka
🇩🇪Altenburg, Germany
private practise Gause
🇩🇪Bad Bramstedt, Germany
private practise Messis
🇩🇪Bad Homburg, Germany
Med. Versorgungszentrum Ambulantes Gesundheitszentrum Charite Campus Mitte
🇩🇪Berlin, Germany
private practise Balzer
🇩🇪Bautzen, Germany
private practise Hasert
🇩🇪Berlin, Germany
private practise Seifert
🇩🇪Berlin, Germany
private practise Manger
🇩🇪Bamberg, Germany
private practise Winkler
🇩🇪Bautzen, Germany
Praxis Roßbacher
🇩🇪Berlin, Germany
private practise Herzberg
🇩🇪Berlin, Germany
private practise Miehe
🇩🇪Berlin, Germany
private practise Bozorg
🇩🇪Berlin, Germany
private practise Brandt-Jürgens
🇩🇪Berlin, Germany
Rheumaklinik Berlin-Buch
🇩🇪Berlin, Germany
private practise Schwichtenberg
🇩🇪Bremen, Germany
Private Practise Wagener
🇩🇪Bruchhausen-Vilsen, Germany
private practise Schnorfeil
🇩🇪Berlin, Germany
private practise Barth
🇩🇪Borna, Germany
private practise Eisterhues
🇩🇪Braunschweig, Germany
Private Practise Ramaker-Brunke
🇩🇪Braunschweig, Germany
private practise Schneider
🇩🇪Chemnitz, Germany
private practise Kirrstetter
🇩🇪Deggendorf, Germany
Kreiskrankenhaus Demmin GmbH
🇩🇪Demmin, Germany
private practise Bebnowski
🇩🇪Dortmund, Germany
private practise Lüthke
🇩🇪Dresden, Germany
private practise Fischer
🇩🇪Dresden, Germany
private practise Oppers
🇩🇪Dresden, Germany
private practise Roch
🇩🇪Dresden, Germany
MVZ Rheumatologie und Autoimmunmedizin GmbH
🇩🇪Hamburg, Germany
Private Practise Höhle
🇩🇪Hamburg, Germany
private practise Strothmeyer
🇩🇪Düsseldorf, Germany
Elbe Elster MVZ GmbH
🇩🇪Elsterwerda, Germany
private practise Müller
🇩🇪Freiberg, Germany
private practise Behringer
🇩🇪Fulda, Germany
Private Practice Abahji
🇩🇪Germering, Germany
private practise Liebhaber
🇩🇪Halle, Germany
private practise Aries
🇩🇪Hamburg, Germany
Private Practise
🇩🇪Giessen, Germany
private practise Dahmen
🇩🇪Hamburg, Germany
private practise Kühne
🇩🇪Haldensleben, Germany
Praxis Praxis Dr. Szabo & Kollegen
🇩🇪Hamm, Germany
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Rheumazentrum SH Mitte GbR
🇩🇪Neumünster, Germany
private practise Kloos
🇩🇪Neuwied, Germany
private practise Voglau
🇩🇪Oldenburg, Germany
Private Practise Stille
🇩🇪Hannover, Germany
private practise Stein
🇩🇪Hannover, Germany
private practise Heilig
🇩🇪Heidelberg, Germany
private practise Meier
🇩🇪Hofheim, Germany
private practise Kapelle
🇩🇪Hoyerswerda, Germany
Uniklinik Jena
🇩🇪Jena, Germany
Kreiskrankenhaus Langenau
🇩🇪Langenau, Germany
private practise Weimann
🇩🇪Magdeburg, Germany
private practise Raub
🇩🇪Münster, Germany
private practise Reck
🇩🇪Mittelherwigsdorf, Germany
private practise Berger
🇩🇪Naunhof, Germany
private practise Klopsch
🇩🇪Neubrandenburg, Germany
private practise Gräßler
🇩🇪Pirna, Germany
Private Practise Petersen
🇩🇪Potsdam, Germany
Private Practise Kotterik
🇩🇪Reutlingen, Germany
private practise Richter
🇩🇪Rostock, Germany
private practise Melzer
🇩🇪Seesen, Germany
Private Practice Fahr
🇩🇪Suhl, Germany
private practise Pyra
🇩🇪Torgelow, Germany
MVZ der Johanniter
🇩🇪Treuenbrietzen, Germany
private practise Fricke-Wagner
🇩🇪Zwickau, Germany
Klinikverbund St. Antonius und St. Josef GmbH, Krankenhaus St. Josef
🇩🇪Wuppertal, Germany
private practise Alliger
🇩🇪Zwiesel, Germany
private practise Kurthen
🇩🇪Aachen, Germany
Private Practise Boehm
🇩🇪Altenholz, Germany
ACURA Rheumazentrum Bad Kreuznach
🇩🇪Bad Kreuznach, Germany
private practise Hesse
🇩🇪Bad Kreuznach, Germany
private practise Ochs
🇩🇪Bayreuth, Germany
private practise Remstedt
🇩🇪Berlin, Germany
private practise Koelnberger
🇩🇪Bogen, Germany
private practise Mall
🇩🇪Bremen, Germany
Mvz Agliomed
🇩🇪Chemnitz, Germany
private practise Feuchtenberger
🇩🇪Burghausen, Germany
private practise Budde
🇩🇪Bückeburg, Germany
private practise Geißler
🇩🇪Cottbus, Germany
private practise Heidlas
🇩🇪Dessau, Germany
private practise Fendler
🇩🇪Duisburg, Germany
private practise Riesopp
🇩🇪Duisburg, Germany
Bezirksklinikum Obermain
🇩🇪Ebensfeld, Germany
private practise Berendt
🇩🇪Eberswalde, Germany
private practise Pech
🇩🇪Eberswalde, Germany
Universitaetsklinikum Essen, Klinik fuer Dermatologie
🇩🇪Essen, Germany
Asklepios MVZ Nord SH GmbH, c/o AK St. Georg
🇩🇪Elmshorn, Germany
MVZ Kaestner + Kaestner GbR
🇩🇪Erfurt, Germany
private practise Freitag
🇩🇪Falkensee, Germany
private practise Koch
🇩🇪Erfurt, Germany
private practise Häckel
🇩🇪Frankenberg, Germany
private practise Höhne
🇩🇪Fraureuth, Germany
Klinikum der J.W. Goethe-Universität, Klinik für Dermatologie, Klinische Forschung
🇩🇪Frankfurt/Main, Germany
private practise Fritzsch
🇩🇪Frankfurt, Germany
private practise Bussmann
🇩🇪Geilenkirchen, Germany
private practise Zeh
🇩🇪Geislingen A.d. Steige, Germany
Praxis Dres. Dr.Brinkmann, Schult, Samimi-Fard
🇩🇪Gladbeck, Germany
Katholisches Marienkrankenhaus Geriatrische Klinik
🇩🇪Hamburg, Germany
private practise Weinhardt
🇩🇪Hamburg, Germany
private practise Lassak-Siedl
🇩🇪Heidelberg, Germany
private Practise Pawlak
🇩🇪Heilbad Heiligenstadt, Germany
private practise Schleußner
🇩🇪Heilbad Heiligenstadt, Germany
private practise Thies
🇩🇪Herrsching, Germany
private practise Wernicke
🇩🇪Hohen Neuendorf, Germany
Private Practice Streibl
🇩🇪Holzkirchen, Germany
private practise Kudela
🇩🇪Magdeburg, Germany
Hautklinik der Universitätsmedizin Mainz KöR,Clinical Research Center
🇩🇪Mainz, Germany
private practise Scholz
🇩🇪Neustadt-Glewe, Germany
Private Practise Hein
🇩🇪Nienburg, Germany
private practise Welcker
🇩🇪Planegg, Germany
private practise Schwokowski
🇩🇪Ratzeburg, Germany
Private Practise Hoene
🇩🇪Rostock, Germany
private practise Biewer
🇩🇪Saarbrücken, Germany
private practise Möbius
🇩🇪Schwerin, Germany
private practise Steinborn
🇩🇪Straubing, Germany
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
Private Practice Jacki
🇩🇪Tübingen, Germany
Berufsausübungsgemeinschaft Dr. med Petra Roll und Dr. Margarete Kratzsch
🇩🇪Ulm / Donau, Germany
private practise Rinaldi
🇩🇪Ulm / Donau, Germany
Private Practise Sprekeler
🇩🇪Zeven, Germany
Charité Berlin Rheumatologie und Klinische Immunologie
🇩🇪Berlin, Germany
private practise Gerlach
🇩🇪Dresden, Germany
MVZ Nord GmbH
🇩🇪Hamburg, Germany
Private Practise Kremers
🇩🇪Jülich, Germany
Private Practise Turin
🇩🇪Karlstadt, Germany
private practise Wilden
🇩🇪Köln, Germany
Praxis Mauer
🇩🇪Kamenz, Germany
private practise Schwab
🇩🇪Kiel, Germany
Office of Parysa Alborz, MD
🇩🇪Koeln, Germany
private practise Straub
🇩🇪Kronach, Germany
private practise Bräunig
🇩🇪Kahla, Germany
private practise Merkel
🇩🇪Königs Wusterhausen, Germany
Boche-Hamann-Teich
🇩🇪Leipzig, Germany
private practise Schwarze
🇩🇪Leipzig, Germany
private practise Wiemers
🇩🇪Leipzig, Germany
private practise Raschke
🇩🇪Magdeburg, Germany
private practise Zimmermann
🇩🇪Malchow, Germany
Praxis Roßbach
🇩🇪Mansfeld OT Großörner, Germany
private practise Vollmer
🇩🇪Monchengladbach, Germany
private practise Zeiger
🇩🇪Leipzig, Germany
private practise Weiß
🇩🇪Lichtenstein, Germany
private practise Holst
🇩🇪Ludwigslust, Germany
Private Practise Legler
🇩🇪Luebeck, Germany
private practise Sieburg
🇩🇪Magdeburg, Germany
private practise Harmuth
🇩🇪Marktredwitz, Germany
Private Practise Bödekker
🇩🇪Marl, Germany
Stadt Klinikum Muenchen
🇩🇪Munchen, Germany
private practise Krüger
🇩🇪München, Germany
Private Practise Vogel
🇩🇪Nürnberg, Germany
private practise Albert
🇩🇪Offenburg, Germany
Knappschaftskrankenhaus Püttlingen
🇩🇪Püttlingen, Germany
private practise Schumann
🇩🇪Reken, Germany
private practise Rumpel
🇩🇪Regensburg, Germany
private practise Baumann
🇩🇪Plauen, Germany
private practise Wassenberg
🇩🇪Ratingen, Germany
Rheumahaus Potsdam GbR
🇩🇪Potsdam, Germany
Private Practise Walter
🇩🇪Rendburg, Germany
Private Practise Mobius
🇩🇪Schwerin, Germany
Private Practise Hoese
🇩🇪Stadthagen, Germany
ZIRS - Zentrum für Interdisziplinäre Rheumatologie Stuttgart
🇩🇪Stuttgart, Germany
private practise Lankow
🇩🇪Rostock, Germany
private practise Ständer
🇩🇪Schwerin, Germany
private practise Engel
🇩🇪Stuttgart, Germany
Company for Medical Study&Service Selters
🇩🇪Selters/Ww, Germany
Praxis Dr. Haas
🇩🇪Tübingen, Germany
Praxis Dres. Winkler-Gyulay, Moeller
🇩🇪Unna, Germany
private practise Otte
🇩🇪Wesel, Germany
private practise Schuart
🇩🇪Wissen/ Luhe, Germany
private practise Metz
🇩🇪Wittstock, Germany
private practise Senger
🇩🇪Wunstorf, Germany
private practise Zinke
🇩🇪Berlin, Germany
private practise Kors
🇩🇪Berlin, Germany