Efficacy and Safety of CDP870 Versus Placebo in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis
Phase 3
Completed
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT00548834
- Lead Sponsor
- UCB Pharma
- Brief Summary
The purpose of this study was to confirm and extend the data from previous studies and to demonstrate the efficacy (in terms of signs and symptoms) and safety of monotherapy with CDP870 administered SC every 4 weeks compared to placebo in patients with active RA who had failed at least one DMARD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
Inclusion Criteria
- male/female, 18-75 years old, inclusive
- diagnosis of adult-onset RA
- had active disease
- had received methotrexate
- on a stable dose of folic acid
Exclusion Criteria
- contraindication for methotrexate or anti-TNF
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method American College of Rheumatology (ACR)-20 responder rate at Week 24 24 weeks
- Secondary Outcome Measures
Name Time Method safety and tolerability every 4 weeks Every 4 weeks effect of CDP870 on health outcomes measures 24 weeks systemic exposures and immunogenic profile of CDP870 24 weeks