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Study to Assess the Efficacy and Safety of Rituximab in Patients With Rheumatoid Arthritis

Phase 2
Completed
Conditions
Rheumatoid Arthritis
Interventions
Drug: methotrexate
Drug: rituximab
Drug: placebo
Drug: corticosteroids
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
GroupInterventionDescription
3methotrexate-
3rituximab-
3corticosteroids-
4methotrexate-
5rituximab-
5corticosteroids-
6rituximab-
7placebo-
1rituximab-
2corticosteroids-
6corticosteroids-
8corticosteroids-
8placebo-
9corticosteroids-
9placebo-
1methotrexate-
2methotrexate-
2rituximab-
4rituximab-
5methotrexate-
6methotrexate-
7methotrexate-
8methotrexate-
9methotrexate-
Primary Outcome Measures
NameTimeMethod
Proportion of patients with an ACR20 response24 weeks
Secondary Outcome Measures
NameTimeMethod
Proportion of patients with ACR(50,70) responses24 weeks
Proportion of patients with an ACR20 response in the medium- and high-dose corticosteroid groups24 weeks
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