World Health Organization site
Skip Navigation Links

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:  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
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:

- 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

- 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
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)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history