A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Ulcerative Colitis

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

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 system to help control the development of inflammation to help reduce painful disease.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Centocor, Inc.
• Treatments: Infliximab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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