Overview

This trial is active, not recruiting.

Condition spondyloarthropathies
Treatments czp 200 mg q2w, czp 400 mg q4w, placebo
Phase phase 3
Sponsor UCB BIOSCIENCES GmbH
Start date March 2010
End date October 2011
Trial size 325 participants
Trial identifier NCT01087762, 2009-011719-19, AS001

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards. At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
czp 200 mg q2w Cimzia
200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
placebo
Matching Placebo to CZP injection.
(Experimental)
Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards. Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.
czp 400 mg q4w Cimzia
400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
placebo
Matching Placebo to CZP injection.
(Placebo Comparator)
Matching Placebo to CZP injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16. After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg Q2W or CZP 400 mg Q4W.
placebo
Matching Placebo to CZP injection.
(Other)
Matching Placebo to CZP injections from Week 0 to Week 16. Subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16 and were treated with three loading doses of CZP 400 mg sc on Weeks 16, 18 and 20, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 22 onwards. Additionally, Placebo injections were administered as appropriate in order to maintain the study blind.
czp 200 mg q2w Cimzia
200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
placebo
Matching Placebo to CZP injection.
(Other)
Matching Placebo to CZP injections from Week 0 to Week 16. Subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16 and were treated with three loading doses of CZP 400 mg sc on Weeks 16, 18 and 20, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 24 onwards. Additionally, Placebo injections were administered as appropriate in order to maintain the study blind.
czp 400 mg q4w Cimzia
400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
placebo
Matching Placebo to CZP injection.
(Other)
Matching Placebo to CZP injections from Week 0 to Week 24. Three loading doses of CZP 400 mg sc were given on Weeks 24, 26 and 28, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 30 onwards. Additionally, Placebo injections were administered as appropriate in order to maintain the study blind.
czp 200 mg q2w Cimzia
200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
placebo
Matching Placebo to CZP injection.
(Other)
Matching Placebo to CZP injections from Week 0 to Week 24. Three loading doses of CZP 400 mg sc were given on Weeks 24, 26 and 28, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 32 onwards. Additionally, Placebo injections were administered as appropriate in order to maintain the study blind.
czp 400 mg q4w Cimzia
400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
placebo
Matching Placebo to CZP injection.

Primary Outcomes

Measure
Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 12
time frame: Week 12

Secondary Outcomes

Measure
Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 24
time frame: Week 24
Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 12
time frame: From Baseline to Week 12
Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24
time frame: From Baseline to Week 24
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12
time frame: From Baseline to Week 12
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24
time frame: From Baseline to Week 24
Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 12
time frame: From Baseline to Week 12
Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 24
time frame: From Baseline to Week 24
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
time frame: From Baseline to Week 12
Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Week 12
time frame: From Baseline to Week 12

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by UCB Pharma.