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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00484237 |
This study will compare the safety and efficacy for two regimens of etanercept in patients with rheumatoid arthritis (RA). The two regimens to be compared are a 25mg twice weekly regimen and a 50mg once weekly regimen.
Condition | Intervention | Phase |
---|---|---|
Rheumatoid Arthritis |
Drug: etanercept |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Multicenter, Parallel Study Evaluating the Safety and Efficacy of Etanercept 10 mg Twice Weekly and 25 mg Once Weekly in Japanese Subjects With Active Rheumatoid Arthritis |
Estimated Enrollment: | 80 |
Study Start Date: | April 2007 |
Study Completion Date: | December 2007 |
This study will compare the safety and efficacy for two regimens of etanercept in patients with rheumatoid arthritis (RA). The two regimens to be compared are a 25mg twice weekly regimen and a 50mg once weekly regimen.
Ages Eligible for Study: | 20 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan | |
Fukuoka, Japan, 810-0001 | |
Kumamoto, Japan, 862-0976 | |
Nagano, Japan, 380-0928 | |
Oita, Japan, 870-0823 | |
Japan, Aomori | |
Goshogawara, Aomori, Japan, 037-0053 | |
Japan, Chiba | |
Yotsukaido, Chiba, Japan, 284-0003 | |
Choseigun, Chiba, Japan, 299-4301 | |
Japan, Fukushima | |
Fukushima City, Fukushima, Japan, 960-8251 | |
Japan, Hiroshima | |
Higashihiroshima, Hiroshima, Japan, 790-0002 | |
Japan, Hyogo | |
Katoh, Hyogo, Japan, 673-1462 | |
Japan, Kanagawa | |
Sagamihara, Kanagawa, Japan, 228-8522 | |
Japan, Miyagi | |
Sendai-City, Miyagi, Japan, 982-0032 | |
Japan, Nagasaki | |
Sasebo, Nagasaki, Japan, 857-1195 |
Study Director: | Medical Monitor | Wyeth |
Study ID Numbers: | 0881A1-3324 |
Study First Received: | June 7, 2007 |
Last Updated: | December 3, 2007 |
ClinicalTrials.gov Identifier: | NCT00484237 |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Rheumatoid Arthritis |
Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases TNFR-Fc fusion protein |
Anti-Inflammatory Agents Immunologic Factors Immune System Diseases Physiological Effects of Drugs Gastrointestinal Agents Immunosuppressive Agents Pharmacologic Actions Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |