Efficacy and Safety Study of BG00012 With Methotrexate in Patients With Active Rheumatoid Arthritis
- Registration Number
- NCT00810836
- Lead Sponsor
- Biogen
- Brief Summary
The purpose of this study is to investigate whether the drug BG00012 can improve the symptoms of rheumatoid arthritis (RA) in patients who are already taking methotrexate for RA, but who still suffer symptoms of RA. The purpose is also to ensure that the combination of methotrexate is safe for patients to take and that any side effects are acceptable to patients with RA.
- Detailed Description
The study is a double-blind, placebo-controlled study of BG00012 plus methotrexate, versus methotrexate alone, in patients with active RA, who have had an incomplete response to other conventional disease modifying anti-rheumatic (DMARD) therapy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 153
Inclusion Criteria
- must be taking methotrexate
- inadequate response to at least one conventional DMARD
- swollen and tender joint count
Exclusion Criteria
- previous treatment with TNF or any other biologic or prosorba column
Other criteria also apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 BG00012 BG00012 480 mg/day 2 BG00012 BG00012 720 mg/day 3 placebo -
- Primary Outcome Measures
Name Time Method The primary objective is the proportion of subjects with ACR20 response in their RA at Week 12. 12 weeks
- Secondary Outcome Measures
Name Time Method To determine the safety and tolerability of BG00012 with methotrexate in this population. 12 weeks
Trial Locations
- Locations (1)
Research Site
πΈπ°Piestany, Slovakia