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

• Status: Completed
• Trial end date: 2007-01-01
• 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Patients who have had ulcerative colitis of at least 3 months' duration at screening

• Patients who have ulcerative colitis confirmed by the biopsy taken at screening

• Patients must have active colitis confirmed during the screening sigmoidoscopy

• Patients must have active disease.

Exclusion Criteria:

• Patients must not be likely to require surgical removal of all or part of the colon within 12 weeks of beginning the study

• Patients 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