Efficacy and Safety of CDP870 and Methotrexate Compared to Methotrexate Alone in Subjects With Rheumatoid Arthritis
Phase 3
Completed
- Conditions
- Arthritis, Rheumatoid
- Registration Number
- NCT00544154
- Lead Sponsor
- UCB Pharma
- Brief Summary
The main purpose of the study was to determine the efficacy of CDP870 in treating RA signs/symptoms in patients who were partial responders to MTX. Other purposes were to show additional efficacy without increased toxicity and the immunogenic response to CDP870 during combined CDP870 and MTX therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 247
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 Rheumatolofy (ACR)-20 responder rate at Week 24
- Secondary Outcome Measures
Name Time Method health outcomes measures immunogenic profile of CDP870 plus methotrexate systemic exposure of CDP870 Safety and tolerability