A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to That of Adalimumab in the Treatment of Biologic Naïve Subjects With Moderately-to-Severely Active Crohn's Disease

The purpose of this study is to compare the efficacy of treatment with ustekinumab or
adalimumab in biologic naive participants with moderately-to-severely active Crohn's disease
(CD) who have previously failed or were intolerant to conventional therapy (corticosteroids
and/or immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate), as
measured by clinical remission at one year.

本研究旨在对比乌司奴单抗（ustekinumab）与阿达木单抗（adalimumab）对中度至重度活动性克罗恩病（Crohn's disease，简称CD）的生物制剂初治患者的治疗效果，这些患者既往对传统治疗（糖皮质激素及/或免疫调节剂，如硫唑嘌呤、6-巯基嘌呤或甲氨蝶呤）应答失败或不耐受，以治疗1年时的临床缓解作为疗效评估指标。