PMS Registry
Company Name
Chugai Pharma Taiwan Ltd.
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