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Sponsors and Collaborators: |
Abbott Eisai Limited |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00235859 |
The purpose of the study is to assess the safety and efficacy of adalimumab compared to placebo in subjects with rheumatoid arthritis on methotrexate therapy.
Condition | Intervention | Phase |
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Rheumatoid Arthritis |
Drug: adalimumab Drug: methotrexate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Human Anti-TNF Antibody Adalimumab Administered as Subcutaneous Injections in Korean Rheumatoid Arthritis Subjects Treated With Methotrexate |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | M02-556 |
Study First Received: | October 7, 2005 |
Last Updated: | August 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00235859 History of Changes |
Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Rheumatoid Arthritis adalimumab |
Anti-Inflammatory Agents Antimetabolites Autoimmune Diseases Immunologic Factors Joint Diseases Arthritis, Rheumatoid Rheumatic Diseases Folic Acid Antagonists Adalimumab |
Immunosuppressive Agents Folic Acid Antibodies Musculoskeletal Diseases Arthritis Connective Tissue Diseases Methotrexate Antirheumatic Agents Immunoglobulins |
Anti-Inflammatory Agents Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Arthritis, Rheumatoid Reproductive Control Agents Adalimumab Musculoskeletal Diseases Arthritis Therapeutic Uses Abortifacient Agents |
Connective Tissue Diseases Methotrexate Dermatologic Agents Nucleic Acid Synthesis Inhibitors Autoimmune Diseases Immune System Diseases Joint Diseases Enzyme Inhibitors Rheumatic Diseases Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Immunosuppressive Agents Pharmacologic Actions Antirheumatic Agents |