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
Verified date | May 2013 |
Source | Genentech, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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). |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Genentech, Inc. | Roche Pharma AG |
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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