Study to Assess the Efficacy and Safety of Rituximab in Patients With Rheumatoid Arthritis
Phase 2
Completed
- Conditions
- Rheumatoid Arthritis
- Interventions
- Registration Number
- NCT00074438
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
This study will assess the efficacy and safety of different treatment regimens of rituximab (MabThera®/Rituxan®), corticosteroids, and placebo, combined with methotrexate (MTX), in patients with active rheumatoid arthritis (RA).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 465
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 methotrexate - 3 rituximab - 3 corticosteroids - 4 methotrexate - 5 rituximab - 5 corticosteroids - 6 rituximab - 7 placebo - 1 rituximab - 2 corticosteroids - 6 corticosteroids - 8 corticosteroids - 8 placebo - 9 corticosteroids - 9 placebo - 1 methotrexate - 2 methotrexate - 2 rituximab - 4 rituximab - 5 methotrexate - 6 methotrexate - 7 methotrexate - 8 methotrexate - 9 methotrexate -
- Primary Outcome Measures
Name Time Method Proportion of patients with an ACR20 response 24 weeks
- Secondary Outcome Measures
Name Time Method Proportion of patients with ACR(50,70) responses 24 weeks Proportion of patients with an ACR20 response in the medium- and high-dose corticosteroid groups 24 weeks