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

Genentech, Inc.465 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

465

Conditions

Rheumatoid Arthritis

Interventions

methotrexateDRUG

Oral or parenteral repeating dose

rituximabDRUG

Intravenous repeating dose

corticosteroidsDRUG

Intravenous repeating dose

placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Eligibility criteria include, but are not limited to the following: * Are between the ages of 18 and 80 years. * Have been diagnosed with rheumatoid arthritis for at least 6 months. * Have failed treatment (lack of efficacy) with at least 1 but no more than 5 disease-modifying anti-rheumatic drugs or biologics (other than methotrexate).

Outcomes

Primary Outcomes

Proportion of patients with an ACR20 response

Time frame: 24 weeks

Secondary Outcomes

Proportion of patients with ACR(50,70) responses

Time frame: 24 weeks

Proportion of patients with an ACR20 response in the medium- and high-dose corticosteroid groups

Time frame: 24 weeks

Data from ClinicalTrials.gov

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