Phase 3
N=325
Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis
Spondyloarthropathies
Bottom Line
View on ClinicalTrials.gov: NCT01087762 ↗Enrolled (actual)
325
Serious AEs
19.4%
Results posted
Dec 2013
Primary outcome: Primary: Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 12 — 38.3; 57.7; 63.6; 60.6 percentage of participants — p==0.004
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CZP 200 mg Q2W (Biological); CZP 400 mg Q4W (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UCB BIOSCIENCES GmbH
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 12 |
38.3; 57.7; 63.6; 60.6 | =0.004 sig |
| SECONDARY Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 24 |
29.0; 66.7; 70.1; 68.3 | <0.001 sig |
| SECONDARY Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 12 |
-0.53; -2.01; -2.02; -2.02 | <0.001 sig |
| SECONDARY Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24 |
-0.40; -2.36; -2.20; -2.28 | <0.001 sig |
| SECONDARY Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12 |
-1.22; -2.82; -2.80; -2.81 | <0.001 sig |
| SECONDARY Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24 |
-1.05; -3.08; -3.01; -3.05 | <0.001 sig |
| SECONDARY Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 12 |
-0.13; -0.60; -0.46; -0.53 | <0.001 sig |
| SECONDARY Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 24 |
-0.07; -0.54; -0.49; -0.52 | <0.001 sig |
| SECONDARY Change From Baseline in the Spine Ankylosing Spondylitis Spine Magnetic Resonance Imaging (MRI) Scoring System for Disease Activity (ASspiMRI-a) in the Berlin Modification at Week 12 |
0.39; -3.39; -2.16; -2.74 | — |
| SECONDARY Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Week 12 |
-1.33; -3.61; -4.98; -4.33 | — |
Summary
The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of two dose regimens of Certolizumab Pegol (CZP) in subjects with active axial Spondyloarthritis (axial SpA).
Eligibility Criteria
Inclusion Criteria
- Documented diagnosis of adult-onset axial Spondyloarthritis (SpA) of at least 3 months' duration as defined by the specified Assessment of Spondyloarthritis International Society (ASAS) criteria
- Active disease as defined by:
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4
- Back pain ≥ 4 on a 0 to 10 Neurobehavioral Rating Scale (NRS) (from BASDAI item 2)
- C-Reactive Protein (CRP) > ULN (Upper Limit of Normal) and/or current evidence (ie, within the last 3 months from Screening) for Sacroiliitis on Magnetic Resonance Imaging (MRI) as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria
- Intolerance to or inadequate response to at least 1 Nonsteroidal Anti-Inflammatory Drug (NSAID)
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 to more than 2 previous biological agents for Axial Spondyloarthritis (SpA)
- 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 (NCT01087762). 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.