Status:
COMPLETED
A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Ulcerative Colitis
Lead Sponsor:
Centocor, Inc.
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of infliximab (Remicade) in patients with Ulcerative Colitis. Infliximab (Remicade) targets specific proteins in the body's immune...
Detailed Description
This study is designed to investigate the safety and effectiveness of infliximab in adult patients with active ulcerative colitis. The purpose of this study is to see if the symptoms of ulcerative col...
Eligibility Criteria
Inclusion
- Patients must have had ulcerative colitis of at least 3 months' duration at screening, confirmed by the biopsy taken at screening
- Patients must have active colitis confirmed during the screening sigmoidoscopy
- Patients must have active disease.
Exclusion
- Patient must not be likely to require surgical removal of all or part of the colon within 12 weeks of beginning the study
- Patient must not require, or required within the 2 months prior to beginning the study, surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
364 Patients enrolled
Trial Details
Trial ID
NCT00096655
Start Date
May 1 2002
End Date
August 1 2007
Last Update
May 17 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.