NCT01551290.

Trial name or title	A phase 3, multicenter, randomized, double‐blind, placebo‐controlled study evaluating the efficacy and safety of infliximab in Chinese subjects with active ulcerative colitis
Methods	Phase III, multicenter, randomized, double‐blind, placebo‐controlled trial
Participants	Adult patients (18 to 65 years) with active ulcerative colitis of at least 3 months duration at screening with score of > 2 on the endoscopy subscore of the Mayo score and baseline Mayo score of 6 to 12
Interventions	Infliximab 5 mg/kg infusion at weeks 0, 2, 6, 14, and 22 Placebo
Outcomes	Primary outcome: clinical response at week 8 Secondary outcomes: clinical remission at week 8, mucosal healing at week 8, clinical response at week 26, clinical remission at week 26
Starting date	April 2012
Contact information	Xian‐Janssen Pharmaceutical Ltd
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