Randomized, Multifactorial, Double-blind, Parallel-group, Dose-ranging Study of the Efficacy and Safety of Rituximab (MabThera®/Rituxan®) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Genentech, Inc.
- Enrollment
- 465
- Primary Endpoint
- Proportion of patients with an ACR20 response
Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
2
Intervention: rituximab (Drug)
2
Intervention: corticosteroids (Drug)
3
Intervention: methotrexate (Drug)
3
Intervention: rituximab (Drug)
3
Intervention: corticosteroids (Drug)
1
Intervention: methotrexate (Drug)
1
Intervention: rituximab (Drug)
2
Intervention: methotrexate (Drug)
4
Intervention: methotrexate (Drug)
4
Intervention: rituximab (Drug)
5
Intervention: methotrexate (Drug)
5
Intervention: rituximab (Drug)
5
Intervention: corticosteroids (Drug)
6
Intervention: methotrexate (Drug)
6
Intervention: rituximab (Drug)
6
Intervention: corticosteroids (Drug)
7
Intervention: methotrexate (Drug)
7
Intervention: placebo (Drug)
8
Intervention: methotrexate (Drug)
8
Intervention: corticosteroids (Drug)
8
Intervention: placebo (Drug)
9
Intervention: methotrexate (Drug)
9
Intervention: corticosteroids (Drug)
9
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Proportion of patients with an ACR20 response
Time Frame: 24 weeks
Secondary Outcomes
- 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)