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

PHASE3CompletedINTERVENTIONAL
Enrollment

99

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

March 31, 2014

Study Completion Date

October 31, 2014

Conditions
Ulcerative Colitis
Interventions
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.

Trial Locations (7)

Unknown

Beijing

Chengdu

Guangzhou

Hefei

Shanghai

Wuhan

Xi'an

All Listed Sponsors
lead

Xian-Janssen Pharmaceutical Ltd.

INDUSTRY

NCT01551290 - A Study to Evaluate the Effectiveness and Safety of Infliximab in Chinese Patients With Active Ulcerative Colitis | Biotech Hunter | Biotech Hunter