Phase 3
Completed N=736
Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo
Axial Spondyloarthrithis · Ankylosing Spondylitis
Source: ClinicalTrials.gov NCT02505542 ↗
Enrolled (actual)
736
Serious AEs
4.4%
Results posted
Apr 2020
Primary outcomePrimary: Percentage of Participants in Part B Who Did Not Experienced a Flare — 20.2; 83.7; 79.0 percentage of participants — p=<0.001
◆ Published Evidence
Established
71citations · ~12 / year
Maintenance of clinical remission in early axial spondyloarthritis following certolizumab pegol dose reduction.
Summary
Patients receive study drug for one year (Part A). If, after the initial run-in phase, a sustained remission is reached they will be randomly split into one of three dose groups for another year (Part B). The maintenance of the sustained remission will be analyzed.
Linked Publications (4)
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Maintenance of clinical remission in early axial spondyloarthritis following certolizumab pegol dose reduction.
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Induction of Sustained Clinical Remission in Early Axial Spondyloarthritis Following Certolizumab Pegol Treatment: 48-Week Outcomes from C-OPTIMISE.
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Comparison of established and preliminarily proposed ASAS MRI working group cut-offs for inflammatory MRI lesions in the sacroiliac joints in radiographic and non-radiographic axial spondyloarthritis.
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Machine learning <i>vs</i> human experts: sacroiliitis analysis from the RAPID-axSpA and C-OPTIMISE phase 3 axSpA trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants in Part B Who Did Not Experienced a Flare |
20.2; 83.7; 79.0 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Sustained Remission at Week 48 in Part A |
43.9 | — |
| SECONDARY Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Week 48 in Part A |
52.5; 22.8; 18.9; 5.9 | — |
| SECONDARY Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Clinical Improvement Categories at Week 48 in Part A |
76.6; 56.1 | — |
| SECONDARY Time to Flare in Part B |
113; 371; NA | <0.001 sig |
| SECONDARY Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Week 96 in Part B |
58.3; 86.2; 69.9; 25.0; 13.8; 22.9 | — |
| SECONDARY Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Clinical Improvement Categories at Week 96 in Part B |
21.2; 82.7; 75.2; 10.6; 67.3; 58.1 | <0.001 sig |
| SECONDARY Percentage of Participants With Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at Week 96 in Part B |
23.1; 85.6; 78.1 | <0.001 sig |
| SECONDARY Percentage of Participants With Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at Week 96 in Part B |
21.2; 84.6; 73.3 | <0.001 sig |
| SECONDARY Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) 5/6 Response Criteria Response at Week 96 in Part B |
12.5; 70.2; 62.9 | <0.001 sig |
| SECONDARY Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) Partial Remission (PR) Response Criteria Response at Week 96 in Part B |
17.3; 77.9; 70.5 | <0.001 sig |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 96 in Part B |
1.66; 0.24; 0.45 | <0.001 sig |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 96 in Part B |
3.02; 0.56; 0.78 | <0.001 sig |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 96 in Part B |
1.90; 0.32; 0.46 | <0.001 sig |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 96 in Part B |
0.21; 0.00; -0.03 | =0.074 |
| SECONDARY Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response Criteria Response at Week 96 in Part B |
22.1; 83.7; 77.1 | <0.001 sig |
| SECONDARY Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Week 96 in Part B |
1.1; 0.2; 0.6 | =0.195 |
| SECONDARY Change From Baseline in Spine Ankylosing Spondylitis Spine Magnetic Resonance Imaging Score for Disease Activity (ASspIMRI-a) in the Berlin Modification Score at Week 96 in Part B |
0.4; 0.0; 0.0 | =0.040 sig |
| SECONDARY Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Escape Week 12 for Participants Who Experienced a Flare in Part B |
63.4; 16.7; 60.0; 26.8; 50.0; 20.0 | — |
| SECONDARY Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Clinical Improvement Categories at Escape Week 12 for Participants Who Experienced a Flare in Part B |
84.5; 16.7; 46.7; 49.3; 0; 13.3 | — |
| SECONDARY Percentage of Participants With Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at Escape Week 12 for Participants Who Experienced a Flare in Part B |
83.3; 50.0; 64.3 | — |
| SECONDARY Percentage of Participants With Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at Escape Week 12 for Participants Who Experienced a Flare in Part B |
69.4; 16.7; 50.0 | — |
| SECONDARY Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) 5/6 Response Criteria Response at Escape Week 12 for Participants Who Experienced a Flare in Part B |
60.6; 16.7; 7.1 | — |
| SECONDARY Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) Partial Remission (PR) Response Criteria Response at Escape Week 12 for Participants Who Experienced a Flare in Part B |
66.7; 16.7; 50.0 | — |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Escape Week 12 for Participants Who Experienced a Flare in Part B |
-2.18; -0.56; -0.83 | — |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Escape Week 12 for Participants Who Experienced a Flare in Part B |
-3.75; -1.55; -2.29 | — |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Escape Week 12 for Participants Who Experienced a Flare in Part B |
-2.52; -0.72; -1.83 | — |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Escape Week 12 for Participants Who Experienced a Flare in Part B |
-0.43; -0.27; -0.26 | — |
| SECONDARY Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Escape Week 12 for Participants Who Experienced a Flare in Part B |
-9.3; 0.0; 0.2 | — |
| SECONDARY Change From Baseline in Spine Ankylosing Spondylitis Spine Magnetic Resonance Imaging Score for Activity (ASspIMRI-a) in the Berlin Modification Score at Escape Week 12 for Participants Who Experienced a Flare in Part B |
-2.3; 0.0; -0.3 | — |
| SECONDARY Certolizumab Pegol (CZP) Plasma Concentration During the Study |
NA; NA; NA; 48.71; 53.39; 48.92 | — |
| SECONDARY Percentage of Participants With Positive Anti-certolizumab Pegol-antibody Levels in Plasma During the Study |
100; 96.1; 100 | — |
| SECONDARY Percentage of Participants With at Least One Adverse Event (AE) During Part A of the Study |
7.3; 67.9 | — |
| SECONDARY Percentage of Participants With at Least One Adverse Event (AE) During Part B of the Study |
54.4; 57.7; 61.0 | — |
| SECONDARY Percentage of Participants With at Least One Adverse Event (AE) and Who Experienced a Flare During Part B of the Study |
51.4; 83.3; 46.7 | — |
Eligibility Criteria
Inclusion Criteria
- Documented diagnosis of adult-onset axial SpondyloArthritis (axSpA) with at least 3 months' symptom duration and meet the Assessment of SpondyloArthritis International Society (ASAS) criteria for axSpA and symptom duration of less than 5 years prior to the participation of this study
- Active disease at Screening as defined by
- Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥ 2.1
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4
- Spinal pain > 4 on a 0 to 10 Numerical Rating Scale (NRS) (from BASDAI Item 2)
- for modified New York (mNY) -negative subjects only: C-reactive Protein (CRP) > upper limit of normal (ULN) and/or current evidence for sacroiliitis on the Screening Magnetic Resonance Imaging (MRI)
- Inadequate response to, or contraindication to, or intolerant to at least 2 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
Exclusion Criteria
- Presence of total Spinal Ankylosis ('bamboo spine')
- Diagnosis of any other Inflammatory Arthritis
- Prior treatment with any experimental biological agents for treatment of Axial SpondyloArthritis (SpA)
- Exposure to more than 1 TNF-antagonist or primary failure to TNF antagonist therapy
- History of or current chronic or recurrent infections
- High risk of infection
- Recent live vaccination
- Concurrent malignancy or a history of malignancy
- Class III or IV congestive heart failure - New York Heart Association (NYHA)
- Demyelinating disease of the central nervous system
- Female subjects who are breastfeeding, pregnant or plan to become pregnant during the study or within 3 months following the last dose of the investigational product
- Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion in the study
Data sourced from ClinicalTrials.gov (NCT02505542) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.