A Study to Evaluate the Effectiveness and Safety of Infliximab in Chinese Patients With Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effectiveness and safety of infliximab in
      Chinese patients with active ulcerative colitis (swelling and ulceration of large intestine
      and rectum).
    

Detailed description: 
      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]).
    

Intervention name(s): Infliximab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Form = solution for injection, route = intravenous (IV), Unit = mg/kg, number = 5, administered on = Weeks 0, 2, 6, 14, and 22 and for extension phase: participants treated with infliximab through Week 22 will receive infliximab at Weeks 30, 38, 46 and 54, and will receive placebo at Week 32 and 34.; Form = solution for injection, route = IV, administered on = Weeks 0, 2, 6, 14, and 22 and for extension phase: participants treated with placebo through Week 22 will receive infliximab at Weeks 32, 34, 38, 46 and 54 and will receive placebo at Week 30.
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Ulcerative colitis; UC; Remicade; Infliximab; Chinese patients; Mayo score; Mucosal healing; Rectal bleeding; Inflammatory bowel disease; IBD