Phase 3
Completed N=317
Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS
axial spondyloarthritis · Nonradiographic Axial Spondyloarthritis · Nr-axSpA
Source: ClinicalTrials.gov NCT02552212 ↗
Enrolled (actual)
317
Serious AEs
4.6%
Results posted
Aug 2020
Primary outcomePrimary: Percentage of Subjects With Ankylosing Spondylitis Disease Activity Score Major Improvement (ASDAS-MI) Response Criteria Response at Week 52 — 7.0; 47.2 percentage of subjects — p=<0.001
◆ Published Evidence
Highly cited
101citations · ~25 / year
Long-term safety and clinical outcomes of certolizumab pegol treatment in patients with active non-radiographic axial spondyloarthritis: 3-year results from the phase 3 C-axSpAnd study.
Summary
Patients with active Axial Spondyloarthritis without x-ray evidence of Ankylosing Spondylitis and with signs of inflammation will be randomly assigned to receive certolizumab pegol (CZP) 200 mg every two weeks or placebo. The primary objective is to demonstrate the efficacy of CZP in these patients.
Linked Publications (4)
-
Long-term safety and clinical outcomes of certolizumab pegol treatment in patients with active non-radiographic axial spondyloarthritis: 3-year results from the phase 3 C-axSpAnd study.
-
Certolizumab Pegol Efficacy in Patients With Non-Radiographic Axial Spondyloarthritis Stratified by Baseline MRI and C-Reactive Protein Status: An Analysis From the C-axSpAnd Study.
-
A Fifty-Two-Week, Randomized, Placebo-Controlled Trial of Certolizumab Pegol in Nonradiographic Axial Spondyloarthritis.
-
Predictors of long-term clinical response in patients with non-radiographic axial spondyloarthritis receiving certolizumab pegol.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Ankylosing Spondylitis Disease Activity Score Major Improvement (ASDAS-MI) Response Criteria Response at Week 52 |
7.0; 47.2 | <0.001 sig |
| PRIMARY Percentage of Subjects With Axial SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 12 |
11.4; 47.8 | <0.001 sig |
| PRIMARY Certolizumab Pegol Plasma Concentration at Baseline |
— | — |
| PRIMARY Certolizumab Pegol Plasma Concentration at Week 1 |
50.5 | — |
| PRIMARY Certolizumab Pegol Plasma Concentration at Week 2 |
36.4 | — |
| PRIMARY Certolizumab Pegol Plasma Concentration at Week 4 |
54.6; 48.8 | — |
| PRIMARY Certolizumab Pegol Plasma Concentration at Week 12 |
29.1; 30.5 | — |
| PRIMARY Certolizumab Pegol Plasma Concentration at Week 24 |
23.5; 24.8 | — |
| PRIMARY Certolizumab Pegol Plasma Concentration at Week 36 |
24.0; 22.9 | — |
| PRIMARY Certolizumab Pegol Plasma Concentration at Week 52 |
22.6 | — |
| PRIMARY Certolizumab Pegol Plasma Concentration at Follow-Up (FU) Visit |
0.2; NA | — |
| SECONDARY Percentage of Subjects With Axial SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 52 |
15.8; 56.6 | <0.001 sig |
| SECONDARY Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Functional Index (BASFI) |
-0.38; -2.07 | <0.001 sig |
| SECONDARY Change From Baseline to Week 52 in the Bath Ankylosing Spondylitis Functional Index (BASFI) |
-1.44; -3.03 | <0.0001 sig |
| SECONDARY Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) |
-0.91; -2.73 | <0.001 sig |
| SECONDARY Change From Baseline to Week 52 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) |
-2.59; -3.88 | <0.001 sig |
| SECONDARY Change From Baseline to Week 12 in Sacroiliac Spondyloarthritis Research Consortium of Canada (SI-SPARCC) Score |
0.200; -4.669 | <0.001 sig |
| SECONDARY Number of Subjects Without Relevant Changes to Background Medication From Baseline to Week 52 |
48; 115 | <0.001 sig |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 52 |
-0.18; -0.36 | <0.001 sig |
| SECONDARY Change From Baseline in ASQoL at Week 1 |
-0.03; -0.11 | — |
| SECONDARY Change From Baseline in ASQoL at Week 2 |
-0.03; -0.16 | — |
| SECONDARY Change From Baseline in ASQoL at Week 4 |
-0.06; -0.18 | — |
| SECONDARY Change From Baseline in ASQoL at Week 12 |
-0.08; -0.28 | — |
| SECONDARY Change From Baseline in ASQoL at Week 24 |
-0.09; -0.31 | — |
| SECONDARY Change From Baseline in ASQoL at Week 36 |
-0.11; -0.33 | — |
| SECONDARY Change From Baseline in ASQoL at Week 48 |
-0.10; -0.34 | — |
| SECONDARY Change From Baseline in Nocturnal Spinal Pain Numerical Rating Scale (NRS) at Week 52 |
-2.1; -4.0 | <0.001 sig |
| SECONDARY Number of Subjects With Anterior Uveitis (AU) or New AU Flares Through Week 52 |
8; 4 | =0.247 |
| SECONDARY Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) During the Study |
63.9; 75.5; 59.4; 65.0; 61.3 | — |
| SECONDARY Percentage of Subjects With Serious Adverse Events (SAEs) During the Study |
2.5; 5.0; 3.1; 5.0; 6.2 | — |
| SECONDARY Percentage of Subjects With Adverse Events Leading to Withdrawal From Investigational Medicinal Product (IMP) During the Study |
1.9; 1.9; 3.1; 0; 2.5 | — |
Eligibility Criteria
Inclusion Criteria
- At least 18 years old at the start of Screening Visit
- A documented diagnosis of adult-onset axial SpondyloArthritis (axSpA) and meet the Assessment of SpondyloArthritis International Society (ASAS) criteria for axSpA
- Subjects must have had back pain for at least 12 months before Screening
- No sacroiliitis defined by Modified New York (mNY) criteria on sacroiliac (SI) x-rays
- Active disease at Screening as defined by
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >= 4
- Spinal pain >= 4 on a 0 to 10 Numerical Rating Scale (NRS)
- Inadequate response to, have a contraindication to, or have been intolerant to at least 2 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
Exclusion Criteria
- Diagnosis of AS or any other Inflammatory Arthritis
- Prior treatment with any experimental biological agents for treatment of Axial SpondyloArthritis (SpA)
- Exposure to more than 1 tumor necrosis factor (TNF)-antagonist or primary failure to TNF antagonist therapy
- History of or current chronic or recurrent infections
- Subjects with known Tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent Tuberculosis (LTB)
- 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 (NCT02552212) 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.