[Translation] A Phase IIIb/IV, randomized, double-blind, double-dummy, active-controlled study comparing the efficacy and safety of upadalimumab with adalimumab in subjects with moderate to severe rheumatoid arthritis who are receiving stable background MTX and who have refractory or intolerant TNF inhibitor therapy alone (SELECT-SWITCH)
第1 阶段的主要目的是在单一TNFi 治疗后效果不佳或不耐受且正接受背景MTX 治疗的成人受试者中,评价乌帕替尼和阿达木单抗的有效性和安全性。
第2 阶段的目的是在完成第1 阶段的受试者中评价乌帕替尼和阿达木单抗的长期安全性、耐受性和有效性。
[Translation] The primary objective of Phase 1 was to evaluate the efficacy and safety of upadalimumab and adalimumab in adult subjects who were refractory to or intolerant of single TNFi therapy and were receiving background MTX.
The objective of Phase 2 was to evaluate the long-term safety, tolerability, and efficacy of upadalimumab and adalimumab in subjects who completed Phase 1.