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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00794898 |
This is an open-label program of Remicade in the treatment of patients with active rheumatoid arthritis (RA) despite treatment with methotrexate (MTX) to determine the onset of efficacy of infliximab.
Condition | Intervention | Phase |
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Arthritis, Rheumatoid |
Biological: Infliximab (Remicade) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Onset of Efficacy of Anti-TNF Chimeric Monoclonal Antibody (Remicade) in the Treatment of Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment |
Enrollment: | 19 |
Study Start Date: | July 2003 |
Study Completion Date: | April 2004 |
Primary Completion Date: | April 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Experimental
Remicade in the treatment of patients with active RA despite treatment with MTX.
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Biological: Infliximab (Remicade)
Infliximab 3 mg/kg infusions at Weeks 0, 2, and 6. All patients will continue to receive the same dose of MTX they were receiving at entry throughout the subsequent treatment period.
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients have active disease, in the opinion of the physician, despite the concomitant use of DMARDS. Evidence of active disease may include any of the following:
6 or more swollen or tender joints; and 2 of the following
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P03027 |
Study First Received: | November 19, 2008 |
Last Updated: | November 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00794898 |
Health Authority: | Malaysia: Ministry of Health |
Autoimmune Diseases Infliximab Joint Diseases Arthritis, Rheumatoid Rheumatic Diseases Antibodies, Monoclonal Folic Acid |
Antibodies Musculoskeletal Diseases Arthritis Connective Tissue Diseases Methotrexate Immunoglobulins |
Anti-Inflammatory Agents Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Gastrointestinal Agents Enzyme Inhibitors |
Reproductive Control Agents Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Therapeutic Uses Abortifacient Agents Antirheumatic Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |