Status:
COMPLETED
A Study of the Safety and Efficacy of Infliximab (Remicade) in Pediatric Patients With Crohn's Disease
Lead Sponsor:
Centocor, Inc.
Collaborating Sponsors:
Centocor BV
Conditions:
Crohn Disease
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief Summary
A study of the safety and efficacy of infliximab (Remicade) in pediatric patients with moderate to severe Crohn's Disease
Detailed Description
This is a medical research study to evaluate the safety and effectiveness of an antibody called infliximab (Remicade) in the treatment of children with Crohn's disease. In this study, subjects will re...
Eligibility Criteria
Inclusion
- Between the ages of 6 and 17 years
- Have had Crohn's disease diagnosed for at least 3 months prior to screening, with gastritis, duodenitis, colitis, ileitis, or ileocolitis, previously confirmed by endoscopy and biopsy
- Have active Crohn's disease despite adequate current treatment with an immunomodulator (ie, AZA, 6-MP, or MTX).
Exclusion
- Disease complications for which surgery might be indicated
- Surgery for bowel diversion with placement of a stoma within 3 months prior to screening
- Positive stool examination for enteric pathogens including Giardia lamblia, Clostridium difficile, Shigella species, and Salmonella species.
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00207675
Start Date
February 1 2003
End Date
August 1 2007
Last Update
May 17 2011
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