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NCT00074438 Clinical Trial

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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00074438
Other study ID # WA17043/U2644g
Secondary ID WA17043
Status Completed
Phase Phase 2
First received December 12, 2003
Last updated May 7, 2013
Start date June 2003
Est. completion date July 2011

Study information
Verified date May 2013
Source Genentech, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 465
Est. completion date July 2011
Est. primary completion date September 2004
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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).

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• methotrexate
Oral or parenteral repeating dose
• rituximab
Intravenous repeating dose
• corticosteroids
Intravenous repeating dose
• placebo
Intravenous repeating dose

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Genentech, Inc. Roche Pharma AG

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of patients with an ACR20 response 24 weeks
Secondary Proportion of patients with ACR(50,70) responses 24 weeks
Secondary Proportion of patients with an ACR20 response in the medium- and high-dose corticosteroid groups 24 weeks
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