Overview

This trial is active, not recruiting.

Condition arthritis, psoriatic
Treatments czp 200 mg q2w, czp 400 mg q4w, placebo
Phase phase 3
Sponsor UCB BIOSCIENCES GmbH
Start date March 2010
End date November 2011
Trial size 409 participants
Trial identifier NCT01087788, 2009-011720-59, PsA001

Summary

Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in subjects with adult onset active and progressive Psoriatic Arthritis (PsA).

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 Certolizumab Pegol (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 and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16. After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (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
American College of Rheumatology 20 (ACR20) Response at Week 12
time frame: Week 12
Change From Baseline in Modified Total Sharp Score (mTSS) in Modification for Psoriatic Arthritis at Week 24
time frame: From Baseline to Week 24

Secondary Outcomes

Measure
American College of Rheumatology 20 (ACR20) Response at Week 24
time frame: Week 24
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 24
time frame: From Baseline to Week 24
Psoriasis Area Severity Index (PASI75) Response at Week 24 in the Subgroup of Subjects With Psoriasis (PSO) Involving at Least 3 % Body Surface Area (BSA) at Baseline
time frame: Week 24
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 48
time frame: From Baseline to Week 48

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Diagnosis of adult-onset Psoriatic Arthritis (PsA) of at least 6 months' duration as defined by the Classification Criteria for Psoriatic Arthritis (CASPAR criteria) - Active Psoriatic Skin Lesions or a documented history of Psoriasis - Active Arthritis with ≥ 3 tender joints at Screening and Baseline, ≥ 3 swollen joints at Screening and Baseline and fulfilling at least 1 of the following 2 criteria during the Screening Period: 1. Erythrocyte Sedimentation Rate (ESR) (Westergren) ≥ 28 mm/hour 2. C-reactive protein (CRP) > Upper Limit Normal (ULN) - Failure to 1 or more treatment with Disease-Modifying Anti-Rheumatic Drugs (DMARDs) Exclusion Criteria: - Diagnosis of any other inflammatory Arthritis or known diagnosis of Fibromyalgia - Exposure to more than 1 Tumor Necrosis Factor α (TNFα) antagonist or to more than 2 previous biological response modifiers for PsA or Psoriasis - Any non-biological systemic treatment of Psoriasis; phototherapy; topical agents - History of chronic or recurrent infections - High risk of infection - Live vaccination within the 8 weeks prior to Baseline - 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 - Clinically significant laboratory abnormalities

Additional Information

Official title Phase 3, Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Subjects With Adult-Onset Active and Progressive Psoriatic Arthritis (PsA)
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by UCB, Inc..