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Sponsors and Collaborators: |
Biogen Idec Hoffmann-La Roche Genentech |
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Information provided by: | Biogen Idec |
ClinicalTrials.gov Identifier: | NCT00468377 |
The purpose of this study is to determine whether repeat treatments with rituximab are safe and effective in patients with rheumatoid arthritis who no longer respond to anti-TNF therapies.
Condition | Intervention | Phase |
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Arthritis, Rheumatoid |
Drug: Rituximab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open Label Study of the Efficacy and Safety of re-Treatments With Rituximab (MabThera/Rituxan) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNFα Therapies |
Enrollment: | 341 |
Study Start Date: | March 2004 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Eligible for re-treatment by the following criteria:
(i) Achieved at least 20% reduction in both SJC and TJC (at the same time) during any visit from Week 16 onwards (in either initial or rituximab rescue therapy), including visits in the post-treatment period. (ii) Swollen joint count (SJC) ≥ 8 (66 joint count) and tender joint count (TJC)≥ 8 (68 joint count).
Exclusion Criteria:
Exclusion Criteria Related to RA:
Excluded Previous/Concomitant Medications:
Exclusions for General Safety:
Laboratory Exclusion Criteria:
Patients may not enter this protocol to be re-treated until any of the following that are present have resolved.
Responsible Party: | Biogen Idec ( Biogen Idec MD ) |
Study ID Numbers: | 102-21 |
Study First Received: | April 30, 2007 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00468377 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Autoimmune Diseases Immunologic Factors Musculoskeletal Diseases Rituximab Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases Antirheumatic Agents |
Autoimmune Diseases Immune System Diseases Immunologic Factors Antineoplastic Agents Rituximab Joint Diseases Physiological Effects of Drugs Arthritis, Rheumatoid |
Rheumatic Diseases Pharmacologic Actions Musculoskeletal Diseases Therapeutic Uses Arthritis Connective Tissue Diseases Antirheumatic Agents |