Status:
COMPLETED
A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis
Lead Sponsor:
Centocor, Inc.
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in children with moderately to severely active ulcerative colitis.
Detailed Description
Ulcerative Colitis (UC) is a disorder involving the lining of the colon. A substance called "tumor necrosis factor" (TNF) naturally occurs in the body. TNF is thought to play an important role in the ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00336492
Start Date
September 1 2006
End Date
April 1 2010
Last Update
July 30 2013
Active Locations (27)
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1
Birmingham, Alabama, United States
2
Phoenix, Arizona, United States
3
Los Angeles, California, United States
4
Denver, Colorado, United States