A Study to Assess the Effectiveness of Certolizumab Pegol in Patients With Axial Spondyloarthritis in Daily Life
- Conditions
- Axial Spondyloarthritis
- Registration Number
- NCT02354105
- Lead Sponsor
- UCB Biopharma S.P.R.L.
- Brief Summary
The primary purpose is to assess the effectiveness of certolizumab pegol in patients with axial spondyloarthritis under routine clinical practice.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 680
- The patient personally signed and dated a Patient Data Consent Form (PDCF) prior to Visit 2. No data can be entered into the electronic Documentation form (eDF) prior to signature of the PDCF.
- The patient must have a clinical diagnosis of active axial spondyloarthritis (axSpA), [ankylosing spondylitis (AS) or nonradiographic axial spondyloarthritis (nr-axSpA)] according to the diagnostic criteria used by the physician in routine clinical practice.
- The decision to prescribe Certolizumab Pegol (CZP) is made by the physician independent of the patient's participation in the NIS.
- The patient must be newly prescribed CZP according to local regulations or guidelines (eg, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >=4).
- Treatment is according to instructions in the Summary of Product Characteristics (SmPC) for patients considered by the treating physician to be reliable and capable of adhering to the observational plan (eg, able to understand and complete questionnaires).
- If a patient is participating in an ongoing investigational study, then he/she will not be able to take part in this study.
N/A
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from Baseline to Week 52 in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in the overall axial spondyloarthritis (axSpA) population, and the ankylosing spondylitis (AS) and nonradiographic axSpA (nr-axSpA) subpopulations From Baseline to Week 52 The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI scores ranges from 0 to 10, with lower scores indicating lower disease activity.
- Secondary Outcome Measures
Name Time Method Assessment of SpondyloArthritis International Society 20 % (ASAS20) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations at Week 24 At Week 24 The ASAS20 response is the improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PtGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and absence of deterioration in the potential remaining domain.
Change from Baseline to Week 12 in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in the overall axSpA population, and the AS and nr-axSpA subpopulations From Baseline to Week 12 The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI scores ranges from 0 to 10, with lower scores indicating lower disease activity.
Change from Baseline to Week 24 in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in the overall axSpA population, and the AS and nr-axSpA subpopulations From Baseline to Week 24 The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI scores ranges from 0 to 10, with lower scores indicating lower disease activity.
Assessment of SpondyloArthritis International Society 20 % (ASAS20) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations at Week 12 At Week 12 The ASAS20 response is the improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PtGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and absence of deterioration in the potential remaining domain.
Assessment of SpondyloArthritis International Society 40 % (ASAS40) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations at Week 12 At Week 12 The ASAS40 response is the relative improvement of at least 40 % and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PtGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain.
Assessment of SpondyloArthritis International Society 20 % (ASAS20) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations at Week 52 At Week 52 The ASAS20 response is the improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PtGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and absence of deterioration in the potential remaining domain.
Assessment of SpondyloArthritis International Society 40 % (ASAS40) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations at Week 52 At Week 52 The ASAS40 response is the relative improvement of at least 40 % and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PtGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain.
Change from Baseline to Week 12 in Patient's Global Assessment of Disease Activity (PtGADA) in the overall axSpA population, and the AS and nr-axSpA subpopulations From Baseline to Week 12 Subjects will score their global assessment of their disease activity in response to the question 'how active was your spondylitis on average during the last week?' using a Numeric Rating Scale (NRS) where 0 is 'not active' and 10 is 'very active'.
Assessment of SpondyloArthritis International Society 40 % (ASAS40) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations at Week 24 At Week 24 The ASAS40 response is the relative improvement of at least 40 % and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PtGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain.
Change from Baseline to Week 12 in Bath Ankylosing Spondylitis Functional Index (BASFI) in the overall axSpA population, and the AS and nr-axSpA subpopulations From Baseline to Week 12 The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function.
Change from Baseline to Week 52 in Bath Ankylosing Spondylitis Functional Index (BASFI) in the overall axSpA population, and the AS and nr-axSpA subpopulations From Baseline to Week 52 The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function.
Change from Baseline to Week 24 in Bath Ankylosing Spondylitis Functional Index (BASFI) in the overall axSpA population, and the AS and nr-axSpA subpopulations From Baseline to Week 24 The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function.
Change from Baseline to Week 24 in Patient's Global Assessment of Disease Activity (PtGADA) in the overall axSpA population, and the AS and nr-axSpA subpopulations From Baseline to Week 24 Subjects will score their global assessment of their disease activity in response to the question 'how active was your spondylitis on average during the last week?' using a Numeric Rating Scale (NRS) where 0 is 'not active' and 10 is 'very active'.
Change from Baseline to Week 52 in Patient's Global Assessment of Disease Activity (PtGADA) in the overall axSpA population, and the AS and nr-axSpA subpopulations From Baseline to Week 52 Subjects will score their global assessment of their disease activity in response to the question 'how active was your spondylitis on average during the last week?' using a Numeric Rating Scale (NRS) where 0 is 'not active' and 10 is 'very active'.
Trial Locations
- Locations (100)
405
🇬🇧Basingstoke, United Kingdom
415
🇬🇧Leicester, United Kingdom
23
🇩🇪Hamburg, Germany
401
🇬🇧Bath, United Kingdom
601
🇧🇪Genk, Belgium
423
🇬🇧Bolton, United Kingdom
53
🇩🇪Altenburg, Germany
18
🇩🇪Bayreuth, Germany
6
🇩🇪Bayreuth, Germany
13
🇩🇪Berlin, Germany
14
🇩🇪Berlin, Germany
16
🇩🇪Berlin, Germany
30
🇩🇪Berlin, Germany
7
🇩🇪Berlin, Germany
4
🇩🇪Burghausen, Germany
11
🇩🇪Dresden, Germany
36
🇩🇪Elmshorn, Germany
25
🇩🇪Chemnitz, Germany
8
🇩🇪Düsseldorf, Germany
35
🇩🇪Erfurt, Germany
50
🇩🇪Cottbus, Germany
26
🇩🇪Greifswald, Germany
41
🇩🇪Goslar, Germany
32
🇩🇪Halle, Germany
19
🇩🇪Freiburg, Germany
47
🇩🇪Hamburg, Germany
1
🇩🇪Hannover, Germany
44
🇩🇪Hannover, Germany
42
🇩🇪Heidelberg, Germany
10
🇩🇪Herne, Germany
40
🇩🇪Hofheim am Taunus, Germany
34
🇩🇪Hoyerswerda, Germany
27
🇩🇪Karlsruhe, Germany
48
🇩🇪Karlstadt, Germany
49
🇩🇪Karlstadt, Germany
21
🇩🇪Leipzig, Germany
38
🇩🇪Leipzig, Germany
2
🇩🇪Naunhof, Germany
29
🇩🇪Marktredwitz, Germany
9
🇩🇪Magdeburg, Germany
31
🇩🇪München, Germany
43
🇩🇪München, Germany
20
🇩🇪Planegg, Germany
24
🇩🇪Potsdam, Germany
15
🇩🇪Püttlingen, Germany
28
🇩🇪Saarbrücken, Germany
51
🇩🇪Wuppertal, Germany
39
🇩🇪Zwickau, Germany
210
🇬🇷Athens, Greece
211
🇬🇷Athens, Greece
207
🇬🇷Lárisa, Greece
502
🇮🇹Potenza, Italy
504
🇮🇹Firenze, Italy
501
🇮🇹Palermo, Italy
500
🇮🇹Siena, Italy
503
🇮🇹Verona, Italy
505
🇮🇹Roma, Italy
116
🇪🇸Barcelona, Spain
114
🇪🇸Bilbao, Spain
122
🇪🇸Cartagena, Spain
108
🇪🇸Córdoba, Spain
120
🇪🇸Granada, Spain
123
🇪🇸Lorca, Spain
107
🇪🇸León, Spain
119
🇪🇸Murcia, Spain
101
🇪🇸Mérida, Spain
117
🇪🇸Salamanca, Spain
118
🇪🇸San Sebastian, Spain
121
🇪🇸Sant Joan Despi, Spain
112
🇪🇸Tarragona, Spain
115
🇪🇸Terrassa, Spain
416
🇬🇧Barnsley, United Kingdom
421
🇬🇧Christchurch, United Kingdom
403
🇬🇧Hull, United Kingdom
420
🇬🇧Leeds, United Kingdom
422
🇬🇧LLandudno, United Kingdom
409
🇬🇧Liverpool, United Kingdom
411
🇬🇧Luton, United Kingdom
414
🇬🇧Manchester, United Kingdom
406
🇬🇧Middlesborough, United Kingdom
424
🇬🇧North Shields, United Kingdom
413
🇬🇧Norwich, United Kingdom
412
🇬🇧Southampton, United Kingdom
419
🇬🇧Stevenage, United Kingdom
418
🇬🇧Sunderland, United Kingdom
408
🇬🇧Torquay, United Kingdom
425
🇬🇧Wigan, United Kingdom
407
🇬🇧Truro, United Kingdom
602
🇧🇪Bruxelles, Belgium
604
🇧🇪Edegem, Belgium
603
🇧🇪Heusy, Belgium
202
🇬🇷Athens, Greece
201
🇬🇷Patra, Greece
203
🇬🇷Thessaloniki, Greece
212
🇬🇷Athens, Greece
208
🇬🇷Maroúsi, Greece
204
🇬🇷Thessaloniki, Greece
205
🇬🇷Thessaloniki, Greece
206
🇬🇷Thessaloníki, Greece
410
🇬🇧Preston, United Kingdom