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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00445770 |
The purpose of this study is to examine the effects of etanercept (10 mg and 25 mg) compared with methotrexate (up to 8 mg per week) on the slowing of joint destruction.
Condition | Intervention | Phase |
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Arthritis, Rheumatoid |
Drug: Etanercept Drug: Methotrexate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Multicenter, Comparative Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Active Rheumatoid Arthritis |
Estimated Enrollment: | 540 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Etanercept
10 or 25 mg, twice weekly, subcutaneous injection for 52 weeks
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2: Experimental |
Drug: Etanercept
10 or 25 mg, twice weekly, subcutaneous injection for 52 weeks
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3: Active Comparator |
Drug: Methotrexate
up to 8 mg per week, oral dosing for 52 weeks
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Ages Eligible for Study: | 20 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Trial Manager | clinicaltrialparticipation@wyeth.com |
Japan | |
Recruiting | |
Kato city Fujita letter Higashiyama, Japan, 944-25 |
Study Director: | Medical Monitor | Wyeth |
Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
Study ID Numbers: | 0881A1-315 |
Study First Received: | March 8, 2007 |
Last Updated: | December 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00445770 |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Rheumatoid Arthritis Arthritis |
Folic Acid Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Methotrexate Rheumatic Diseases TNFR-Fc fusion protein |
Antimetabolites Anti-Inflammatory Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Sensory System Agents Therapeutic Uses Abortifacient Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics |
Dermatologic Agents Nucleic Acid Synthesis Inhibitors Immune System Diseases Gastrointestinal Agents Enzyme Inhibitors Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Immunosuppressive Agents Pharmacologic Actions Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |