A Study to Assess the Effectiveness of Certolizumab Pegol in Patients With Axial Spondyloarthritis in Daily Life
CIMAX
A Noninterventional Study to Assess the Effectiveness of Certolizumab Pegol in Patients With Axial Spondyloarthritis in Daily Practice
1 other identifier
observational
680
6 countries
100
Brief Summary
The primary purpose is to assess the effectiveness of certolizumab pegol in patients with axial spondyloarthritis under routine clinical practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2015
Typical duration for all trials
100 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 12, 2015
CompletedFirst Submitted
Initial submission to the registry
January 29, 2015
CompletedFirst Posted
Study publicly available on registry
February 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 9, 2018
CompletedMarch 11, 2019
March 1, 2019
3.2 years
January 29, 2015
March 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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.
From Baseline to Week 52
Secondary Outcomes (14)
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
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
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
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
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
- +9 more secondary outcomes
Study Arms (1)
CZP treatment
axSpA patients who have been newly prescribed Certolizumab Pegol (CZP).
Eligibility Criteria
Patients with axial spondyloarthritis (axSpA) (including both ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis (nr-axSpA)) who have been newly prescribed Certolizumab Pegol (CZP) by the treating physician in regular course of practice.
You may qualify if:
- 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.
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Biopharma S.P.R.L.lead
- Parexelcollaborator
Study Sites (100)
602
Brussels, Belgium
604
Edegem, Belgium
601
Genk, Belgium
603
Heusy, Belgium
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
25
Chemnitz, Germany
50
Cottbus, Germany
11
Dresden, Germany
8
Düsseldorf, Germany
36
Elmshorn, Germany
35
Erfurt, Germany
19
Freiburg im Breisgau, Germany
41
Goslar, Germany
26
Greifswald, Germany
32
Halle, Germany
23
Hamburg, Germany
47
Hamburg, Germany
1
Hanover, Germany
44
Hanover, Germany
42
Heidelberg, Germany
10
Herne, Germany
40
Hofheim am Taunus, Germany
34
Hoyerswerda, Germany
27
Karlsruhe, Germany
48
Karlstadt am Main, Germany
49
Karlstadt am Main, Germany
21
Leipzig, Germany
38
Leipzig, Germany
9
Magdeburg, Germany
29
Marktredwitz, Germany
31
München, Germany
43
München, Germany
2
Naunhof, Germany
20
Planegg, Germany
24
Potsdam, Germany
15
Püttlingen, Germany
28
Saarbrücken, Germany
51
Wuppertal, Germany
39
Zwickau, Germany
202
Athens, Greece
210
Athens, Greece
211
Athens, Greece
212
Athens, Greece
207
Larissa, Greece
208
Marousi, Greece
201
Pátrai, Greece
203
Thessaloniki, Greece
204
Thessaloniki, Greece
205
Thessaloniki, Greece
206
Thessaloniki, Greece
504
Florence, Italy
501
Palermo, Italy
502
Potenza, Italy
505
Roma, Italy
500
Siena, Italy
503
Verona, Italy
116
Barcelona, Spain
114
Bilbao, Spain
122
Cartagena, Spain
108
Córdoba, Spain
118
Donostia / San Sebastian, Spain
120
Granada, Spain
107
León, Spain
123
Lorca, Spain
101
Mérida, Spain
119
Murcia, Spain
117
Salamanca, Spain
121
Sant Joan Despí, Spain
112
Tarragona, Spain
115
Terrassa, Spain
416
Barnsley, United Kingdom
405
Basingstoke, United Kingdom
401
Bath, United Kingdom
423
Bolton, United Kingdom
421
Christchurch, United Kingdom
403
Hull, United Kingdom
420
Leeds, United Kingdom
415
Leicester, United Kingdom
409
Liverpool, United Kingdom
422
Llandudno, United Kingdom
411
Luton, United Kingdom
414
Manchester, United Kingdom
406
Middlesbrough, United Kingdom
424
North Shields, United Kingdom
413
Norwich, United Kingdom
410
Preston, United Kingdom
412
Southampton, United Kingdom
419
Stevenage, United Kingdom
418
Sunderland, United Kingdom
408
Torquay, United Kingdom
407
Truro, United Kingdom
425
Wigan, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Cares
+1 844 599 2273 (UCB)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2015
First Posted
February 3, 2015
Study Start
January 12, 2015
Primary Completion
March 9, 2018
Study Completion
March 9, 2018
Last Updated
March 11, 2019
Record last verified: 2019-03