A Phase 2a, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study to Evaluate the Efficacy, Safety and Tolerability of BG00012 When Given With Methotrexate to Subjects With Active RA Who Have Had an Inadequate Response to Conventional Disease-Modifying Anti-rheumatic Drug Therapy
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Biogen
- Enrollment
- 153
- Locations
- 1
- Primary Endpoint
- The primary objective is the proportion of subjects with ACR20 response in their RA at Week 12.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
1
BG00012 480 mg/day
Intervention: BG00012 (Drug)
2
BG00012 720 mg/day
Intervention: BG00012 (Drug)
3
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
The primary objective is the proportion of subjects with ACR20 response in their RA at Week 12.
Time Frame: 12 weeks
Secondary Outcomes
- To determine the safety and tolerability of BG00012 with methotrexate in this population.(12 weeks)