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Sponsors and Collaborators: |
Genentech Biogen Idec |
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Information provided by: | Genentech |
ClinicalTrials.gov Identifier: | NCT00443651 |
This is a Phase III, open-label study of a total of approximately 560 subjects with active RA who have had an inadequate response to one or more DMARDs. The study will be conducted in two stages. For Stage I of the study, approximately 400 subjects receiving non-biologic DMARDs (with the exception of MTX monotherapy or MTX and leflunomide combination therapy) will be enrolled. In addition, during Stage II, approximately 160 subjects receiving an FDA-approved biologic DMARD at the time of screening will be enrolled.
Condition | Intervention | Phase |
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Rheumatoid Arthritis |
Drug: rituximab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | An Open-Label, Prospective Study of the Safety of Rituximab in Combination With Other Disease-Modifying Anti-Rheumatic Drugs in Subjects With Active Rheumatoid Arthritis |
Estimated Enrollment: | 560 |
Study Start Date: | January 2007 |
Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: rituximab
Intravenous repeating dose
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria (Stage I):
Exclusion Criteria (Stage I):
Inclusion Criteria (Stage II):
Exclusion Criteria (Stage II):
Contact: Ritu Namdev | namdev.ritu@gene.com |
Study Director: | Micki Klearman, M.D. | Genentech |
Responsible Party: | Genentech, Inc. ( Clinical Trials Posting Group ) |
Study ID Numbers: | U3924g |
Study First Received: | March 2, 2007 |
Last Updated: | September 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00443651 |
Health Authority: | United States: Food and Drug Administration |
Rituxan RA |
Autoimmune Diseases Musculoskeletal Diseases Rituximab Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |
Immunologic Factors Immune System Diseases Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Antirheumatic Agents Pharmacologic Actions |