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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.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00207662
Date of registration: 13/09/2005
Prospective Registration: No
Primary sponsor: Centocor, Inc.
Public title: A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Moderate to Severe Active Crohn's Disease
Scientific title: ACCENT I - A Randomized, Double-blind, Placebo-controlled Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab, Remicade) in the Long-term Treatment of Patients With Moderately to Severely Active Crohn's Disease
Date of first enrolment: July 2000
Target sample size: 580
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00207662
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
Contacts
Name:     Centocor, Inc. Clinical Trial
Address: 
Telephone:
Email:
Affiliation:  Centocor, Inc.
Key inclusion & exclusion criteria

Inclusion Criteria:

- Men and women >=18 years of age

- Diagnosis of Crohn's

- Crohn's disease of at least 3 months duration, with colitis, ileitis, or ileocolitis,
confirmed by radiography or endoscopy

Exclusion Criteria:

- Local manifestations of Crohn's disease such as strictures, abscesses, or other
disease

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

- Positive stool culture



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Crohn Disease
Intervention(s)
Drug: infliximab or placebo
Primary Outcome(s)
Reductions in the signs and symptoms of Crohn's disease
Secondary Outcome(s)
Clinical remission;reduction in the use corticosteroids; mucosal healing
Secondary ID(s)
CR004771
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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