A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis

PHASE3CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

September 30, 2006

Primary Completion Date

May 31, 2009

Study Completion Date

April 30, 2010

Conditions
Ulcerative Colitis
Interventions
BIOLOGICAL

infliximab

infusion of 5mg/kg at weeks 0, 2, 6 followed by every 12 wks through week 42; infliximab - Could receive infusion of 10mg/kg every 8 weeks up to week 42; infliximab - Could receive infusion of 5mg/kg every 8 weeks up to week 42

BIOLOGICAL

infliximab

infusion of 5mg/kg at weeks 0, 2, 6 followed by every 8 wks through week 46; infliximab - Could receive infusion of 10mg/kg every 8 weeks up to week 46

BIOLOGICAL

infliximab

infliximab - Could receive infusion of 10 mg/kg every 8 weeks up to week 42

BIOLOGICAL

infliximab

infusion of 5mg/kg at weeks 0, 2, 6, then every 12 wks through week 42

Trial Locations (27)

Unknown

Birmingham

Phoenix

Los Angeles

Denver

Hartford

Orlando

Atlanta

Chicago

Indianapolis

Boston

Rochester

New Hyde Park

Durham

Cleveland

Columbus

Dayton

Providence

Milwaukee

Antwerp

Leuven

Vancouver

Hamilton

Toronto

Edmonton

Halifax

Hvidovre

Rotterdam

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Centocor, Inc.

INDUSTRY