Company Name | Chugai Pharma Taiwan Ltd. |
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Protocol Number | TW-TCZ-14001(E)~14004(E) |
Title of Study | Efficacy and safety evaluation of tocilizumab monotherapy in Taiwan population |
Primary Objective | -To demonstrate non-inferiority of tocilizumab monotherapy to tocilizumab 8 mg/kg combine DMARDs -Sub study: observation study of tocilizumab 4 mg/kg -To evaluate safety profile of long term treatment |
Number of Sites | 23 |
Period of Study | From:July 2015 to:June 2018 |
Number of Patients | 480人 |
IRB Approval Date | 長庚 May 05, 2015; 嘉基 May 28, 2015; other IRBs not yet |
Publication Plan / Date | 2017 |