A Study to Evaluate the Effectiveness and Safety of Infliximab in Chinese Patients With Active Ulcerative Colitis

Primary Outcome Measures:

• Number of participants with a clinical response at Week 8 [ Time Frame: Week 8 ]
  At Week 8, clinical response is defined as a decrease from baseline (closest measurement taken prior to or at the time of the initiation of the baseline [Week 0] infusion) in the Mayo score by ≥30% and ≥3 points, with a decrease in the rectal bleeding subscore of ≥1 or a rectal bleeding subscore of 0 or 1, at Week 8.
  
  

Secondary Outcome Measures:

• Number of participants in clinical remission at Week 8 [ Time Frame: Week 8 ]
  A clinical remission at Week 8 is defined as a Mayo score ≤2 points, with no individual subscore >1. Participants in remission by this definition will have rectal bleeding subscore of either 0 or 1.
  
  
• Number of participants with mucosal healing at Week 8 [ Time Frame: Week 8 ]
  Mucosal healing is determined from the endoscopy subscore of the Mayo score. Mucosal healing will be defined by endoscopy subscore of 0 or 1.
  
  
• Number of participants with a clinical response at Week 26 [ Time Frame: Week 26 ]
  At Week 26, clinical response is defined as decrease from baseline in the Mayo score by ≥30% and ≥3 points, with a decrease in the rectal bleeding subscore of ≥1 or a rectal bleeding subscore of 0 or 1, at Week 26.
  
  
• Number of participants in clinical remission at Week 26 [ Time Frame: Week 26 ]
  A clinical remission at Week 26 is defined as a Mayo score ≤2 points, with no individual subscore >1. Participants in remission by this definition will have rectal bleeding subscore of either 0 or 1.
  
  

This is a multicenter (study conducted at multiple sites), randomized (the study medication is assigned by chance), placebo controlled (placebo is an inactive substance that is compared with a medication to test whether the medication has a real effect in a clinical study), double blind (neither investigator nor patient knows the treatment that the patient receives), 2-arm (2 groups), parallel group (a clinical study comparing the response in two or more groups of participants receiving different treatments) study with infliximab in patients with active ulcerative colitis. The study consists of screening period (4 weeks prior to baseline [patient's medical status before any treatment or research is done] at Week 0), treatment period (Week 0 to Week 22) and follow up period (Week 26). Participants completing treatment till Week 22 and benefit from continued treatment (in the opinion of the investigator) may enter a study extension period from Week 30 until Week 58. Hundred participants will be randomized to 2 groups: Group 1 (50 participants receiving placebo) and Group 2 (50 participants receiving infliximab). Effectiveness and safety (physical examination, and a review of AEs, vital signs, laboratory analyses, and concomitant medications) will be evaluated at Week 8 and Week 26 and at Week 58 (for participants who enter extension phase). The maximum duration for participants in the main study is 26 weeks. The maximum duration for participants including study extension is 58 weeks. One of the specialized procedures used to calculate efficacy will be Mayo score which is calculated using the subscore (recorded in Mayo Diary Card by each participant) of the following 4 variables (1) stool frequency (scores ranging from 0 [normal number stools for this patient] to 3 [5 or more stools more than normal]), (2) rectal bleeding (scores ranging from 0 [no blood seen] to 3 [blood alone passed]), (3) endoscopic findings (scores ranging from 0 [normal or inactive disease] to 3 [severe disease ie, spontaneous bleeding and ulceration]), and (4) the physician's global assessment (scores ranging from 0 [normal] to 3 [severe disease]).