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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:  NCT00207766
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 Subjects With Fistulizing Crohn's Disease
Scientific title: ACCENT II - A Randomized, Double-blind, Placebo-controlled Trial of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) in the Long Term Treatment of Patients With Fistulizing CROHN'S Disease
Date of first enrolment: June 2000
Target sample size: 306
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, 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:

- Single or multiple draining fistulas

- Crohn's disease of at least 3 months' duration,

Exclusion Criteria:

- Crohn's disease complications for which surgery might be indicated

- Positive stool culture

Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Crohn Disease
Drug: infliximab or placebo
Primary Outcome(s)
Reduction in the number of draining fistulas
Secondary Outcome(s)
Complete fistula response (no draining fistula).
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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