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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 19 February 2015
Main ID:  NCT00207675
Date of registration: 13/09/2005
Prospective Registration: No
Primary sponsor: Centocor, Inc.
Public title: A Study of the Safety and Efficacy of Infliximab (Remicade) in Pediatric Patients With Crohn's Disease
Scientific title: A Randomized, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Anti-TNF a Chimeric Monoclonal Antibody (Infliximab, REMICADE) in Pediatric Subjects With Moderate to Severe CROHN'S Disease.
Date of first enrolment: February 2003
Target sample size: 112
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
Name:     Centocor, Inc. Clinical Trial
Affiliation:  Centocor, Inc.
Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- Disease complications for which surgery might be indicated

- Surgery for bowel diversion with placement of a stoma within 3 months prior to

- Positive stool examination for enteric pathogens including Giardia lamblia,
Clostridium difficile, Shigella species, and Salmonella species.

Age minimum: 6 Years
Age maximum: 17 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Crohn Disease
Drug: infliximab
Primary Outcome(s)
Clinical response at Week 10, defined as a decrease from baseline in the PCDAI score of at least 15 points with a total score of no more than 30 points at Week 10.
Secondary Outcome(s)
Clinical response at Week 54; Clinical remission at Week 54; Change from baseline in corticosteroid use at Week 54; Change from baseline in height status at Week 54
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Centocor BV
Ethics review
Results available:
Date Posted:
Date Completed:
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