NCT01551290

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

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Infliximab in Chinese Subjects With Active Ulcerative Colitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Xian-Janssen Pharmaceutical Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 \[severe disease\]).

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Infliximab	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.
DRUG	Placebo	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.

Timeline

• Start date: 2012-04-01
• Primary completion: 2014-03-01
• Completion: 2014-10-01
• First posted: 2012-03-12
• Last updated: 2015-10-30

Locations

7 sites across 1 country: China