Status:
COMPLETED
A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Moderate to Severe Active Crohn's Disease
Lead Sponsor:
Centocor, Inc.
Conditions:
Crohn Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a study of infliximab (Remicade) in subjects with Crohn's disease
Detailed Description
Crohn's disease is a disease characterized by inflammation (the changes that happen when tissues in the body are injured) and ulceration (formation of pus) of the bowel. The purpose of this study is t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
580 Patients enrolled
Trial Details
Trial ID
NCT00207662
Start Date
July 1 2000
End Date
November 1 2005
Last Update
April 27 2010
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