| Company Name | Pfizer Inc. |
|---|---|
| Protocol Number | A3921187 |
| Title of Study | A Phase 3b/4 Randomized Double Blind Study Of 5 mg Of Tofacitinib With And Without Methotrexate In Comparison To Adalimumab With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis |
| Primary Objective | 1.To compare the efficacy of 5 mg BID of tofacitinib (with and without background MTX) to adalimumab with MTX as measured by American College of Rheumatology 50% improvement (ACR50) response rates at Month 6. 2. To compare the efficacy of 5 mg BID of tofacitinib monotherapy to 5 mg BID tofacitinib with MTX as measured by ACR50 response rates at Month 6. |
| Number of Sites | 6 |
| Period of Study | From：Feb 2015 to：May 2017 |
| Number of Patients | Expected to enroll 47 subjects in Taiwan人 |
| IRB Approval Date | Kaohsiung Veterans General Hospital 26-Sep-14 Kaohsiung Medical University Chung-Ho Memorial Hospital 12-Sep-14 Chung Shan Medical University Hospital 19-Sep-14 Chang Gung Medical Foundation-Linkou Branch 5-Sep-14 Taipei Veterans General Hospital 27-Aug-14 Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation 26-Aug-14 |
| Publication Plan / Date | April 28, 2015 |
