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Sponsors and Collaborators: |
Elan Pharmaceuticals Biogen Idec |
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Information provided by: | Elan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00831649 |
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of natalizumab in subjects with active rheumatoid arthritis (RA) receiving concomitant methotrexate (MTX)
Condition | Intervention | Phase |
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Rheumatoid Arthritis |
Drug: TYSABRI (natalizumab) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | A Phase II, Multicenter, Open-Label, Long-Term Study of the Safety, Tolerability, and Efficacy of Intravenous Natalizumab in Subjects With Rheumatoid Arthritis Who Have Previously Participated in Study ELN100226-RA201 |
Study Start Date: | September 2004 |
Primary Completion Date: | February 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
natalizumab: Experimental | Drug: TYSABRI (natalizumab) |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA
Subjects will be eligible to begin study participation if they meet all of the following inclusion criteria:
EXCLUSION CRITERIA
Subjects will be excluded from the study if they meet any of the following exclusion criteria:
Responsible Party: | Elan Pharmaceuticals ( Elan Pharmaceuticals ) |
Study ID Numbers: | ELN100226-RA251 |
Study First Received: | January 27, 2009 |
Last Updated: | January 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00831649 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |
Autoimmune Diseases Immune System Diseases Musculoskeletal Diseases Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |