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

Sponsor

Genentech, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00074438

Collaborator

Roche Pharma AG (Industry)

465

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: methotrexate Drug: rituximab Drug: corticosteroids Drug: placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

465 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2003

Actual Primary Completion Date :

Sep 1, 2004

Actual Study Completion Date :

Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: methotrexate Oral or parenteral repeating dose Drug: rituximab Intravenous repeating dose
Experimental: 2	Drug: methotrexate Oral or parenteral repeating dose Drug: rituximab Intravenous repeating dose Drug: corticosteroids Intravenous repeating dose
Experimental: 3	Drug: methotrexate Oral or parenteral repeating dose Drug: rituximab Intravenous repeating dose Drug: corticosteroids Intravenous repeating dose
Experimental: 4	Drug: methotrexate Oral or parenteral repeating dose Drug: rituximab Intravenous repeating dose
Experimental: 5	Drug: methotrexate Oral or parenteral repeating dose Drug: rituximab Intravenous repeating dose Drug: corticosteroids Intravenous repeating dose
Experimental: 6	Drug: methotrexate Oral or parenteral repeating dose Drug: rituximab Intravenous repeating dose Drug: corticosteroids Intravenous repeating dose
Placebo Comparator: 7	Drug: methotrexate Oral or parenteral repeating dose Drug: placebo Intravenous repeating dose
Placebo Comparator: 8	Drug: methotrexate Oral or parenteral repeating dose Drug: corticosteroids Intravenous repeating dose Drug: placebo Intravenous repeating dose
Placebo Comparator: 9	Drug: methotrexate Oral or parenteral repeating dose Drug: corticosteroids Intravenous repeating dose Drug: placebo Intravenous repeating dose

Outcome Measures

Primary Outcome Measures

Proportion of patients with an ACR20 response [24 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).