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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00049751 |
The purpose of the study is to evaluate safety by collecting serious adverse events in subjects with moderately to severely active rheumatoid arthritis who are unable to obtain etanercept and who have failed one or more prior disease-modifying antirheumatic drugs (DMARDs).
Condition | Intervention | Phase |
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Rheumatoid Arthritis |
Drug: Adalimumab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter Study of the Safety of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects With Active Rheumatoid Arthritis |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
Principal Investigator: | William M. Edwards, M.D. | Low Country Research Center, North Charelston SC |
Study ID Numbers: | M02-498 |
Study First Received: | November 13, 2002 |
Last Updated: | August 13, 2006 |
ClinicalTrials.gov Identifier: | NCT00049751 |
Health Authority: | United States: Food and Drug Administration |
Antibodies, Monoclonal Antibodies Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases Adalimumab Immunoglobulins |
Anti-Inflammatory Agents Immunologic Factors Immune System Diseases Therapeutic Uses |
Physiological Effects of Drugs Antirheumatic Agents Pharmacologic Actions |