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Sponsored by: |
Centocor, Inc. |
---|---|
Information provided by: | Centocor, Inc. |
ClinicalTrials.gov Identifier: | NCT00269867 |
The purpose of this study is to evaluate the safety and effectiveness of infliximab (an anti-TNF chimeric monoclonal antibody [cA2]) in patients with active Rheumatoid Arthritis, despite methotrexate treatment.
Condition | Intervention | Phase |
---|---|---|
Rheumatoid Arthritis |
Drug: Infliximab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Placebo-Controlled, Double-Blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment |
Estimated Enrollment: | 428 |
This is a placebo-controlled, double-blinded, randomized clinical study to evaluate the safety and effectiveness of infliximab in patients with active Rheumatoid Arthritis, despite methotrexate treatment. Infliximab is an anti-TNF chimeric monoclonal antibody (cA2). The primary measures of effectiveness include the change from baseline in American College of Rheumatology (ACR20) response at week 30, and the change in the modified van der Heijde Sharp Score. The ACR20 Responder Index a composite of clinical, laboratory, and functional measures and the van der Heijde-Sharp (vdH-S) scoring method is a method of rating structural damage in patients..
Patients will be treated with either infliximab or matching placebo.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR006259 |
Study First Received: | December 22, 2005 |
Last Updated: | April 6, 2007 |
ClinicalTrials.gov Identifier: | NCT00269867 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Rheumatoid Arthritis infliximab methotrexate |
Anti-Inflammatory Agents Antimetabolites Autoimmune Diseases Immunologic Factors Infliximab Joint Diseases Arthritis, Rheumatoid Rheumatic Diseases Folic Acid Antagonists Immunosuppressive Agents |
Folic Acid Antibodies, Monoclonal Antibodies Musculoskeletal Diseases Arthritis Connective Tissue Diseases Methotrexate Antirheumatic Agents Immunoglobulins |
Anti-Inflammatory Agents Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Infliximab Antineoplastic Agents Physiological Effects of Drugs Arthritis, Rheumatoid Reproductive Control Agents Musculoskeletal Diseases Arthritis Therapeutic Uses Abortifacient Agents Connective Tissue Diseases |
Methotrexate Dermatologic Agents Nucleic Acid Synthesis Inhibitors Autoimmune Diseases Immune System Diseases Joint Diseases Gastrointestinal Agents Enzyme Inhibitors Rheumatic Diseases Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Immunosuppressive Agents Pharmacologic Actions Antirheumatic Agents |