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

Completed · Phase 3

Conditions studied: Ulcerative Colitis

In brief

The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in children with moderately to severely active ulcerative colitis.

Key facts

Study ID

NCT00336492

Run by

Centocor, Inc.

People needed

60

Starts

2006-09-01

Expected to finish

2010-04-01

Last updated by the study team

2013-07-30

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have moderately to severely active ulcerative colitis
• Diagnosed with ulcerative colitis for 2 weeks before screening
• Male patients who are sexually active and female patients who are sexually active or of childbearing potential must use adequate birth control while participation in the study and for 6 months after the last infusion.

You may not qualify if…

• History of latent or active TB
• Have had a live viral or bacterial vaccination within 3 months before screening
• Have or have had serious infections within 3 months before screening
• Prior treatment with infliximab

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Los Angeles, California, United States
• Study site — Denver, Colorado, United States
• Study site — Hartford, Connecticut, United States
• Study site — Orlando, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Boston, Massachusetts, United States
• Study site — Rochester, Minnesota, United States
• Study site — New Hyde Park, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Cleveland, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Dayton, Ohio, United States
• Study site — Providence, Rhode Island, United States
• Study site — Milwaukee, Wisconsin, United States
• Study site — Antwerp, Belgium
• Study site — Leuven, Belgium
• Study site — Vancouver, British Columbia, Canada
• Study site — Hamilton, Ontario, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Edmonton, Canada
• Study site — Halifax, Canada

Full record on ClinicalTrials.gov

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