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Sponsors and Collaborators: |
Abbott Abbott Japan Co.,Ltd Eisai Limited |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00235833 |
The purpose of the study is to assess the long-term safety and tolerability of repeated administration of adalimumab in adult Japanese subjects with rheumatoid arthritis.
Condition | Intervention | Phase |
---|---|---|
Rheumatoid Arthritis |
Biological: adalimumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Long-Term Continuously Repeated Dose Study of Adalimumab (D2E7) in Patients With Rheumatoid Arthritis |
Enrollment: | 25 |
Study Start Date: | June 2003 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Adalimumab 40 mg eow: Experimental |
Biological: adalimumab
40 mg eow, sc
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Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
A subject who experienced any of the following during the prior adalimumab sc dosing study:
Japan, Metropolis | |
Tokyo, Metropolis, Japan | |
Japan, Prefecture | |
Ibaraki, Prefecture, Japan | |
Saitama, Prefecture, Japan | |
Nagasaki, Prefecture, Japan | |
Hiroshima, Prefecture, Japan | |
Fukuoka, Prefecture, Japan | |
Osaka, Prefecture, Japan |
Study Director: | Shigeki Hashimoto, Ph.D. | Abbott |
Responsible Party: | Abbott ( Eiichi Makino ) |
Study ID Numbers: | M02-564 |
Study First Received: | October 7, 2005 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00235833 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Rheumatoid Arthritis |
Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases Adalimumab |
Anti-Inflammatory Agents Immune System Diseases Therapeutic Uses Antirheumatic Agents Pharmacologic Actions |