A Long Term Safety Study of Infliximab (Remicade) in in Ulcerative Colitis Patients

• Status: Completed
• Trial end date: 2015-09-09
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate long-term safety information of infliximab in patients who have participated in infliximab clinical studies in ulcerative colitis.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Collaborator: Janssen Biologics BV
• Treatments: Infliximab

Criteria

Inclusion Criteria:

• All patients enrolled in three Phase 3 Janssen-sponsored (C0168T37, C0168T46, C0168T72) infliximab clinical studies in ulcerative colitis that require long-term safety follow-up

• Patients must have received at least 1 dose of study agent to be eligible for participation in the study

Exclusion Criteria:

• Patients who refuse consent or are unwilling to respond to requests for long-term safety information within the required timeframe will be excluded. In addition, patients participating in a study extension to the primary study are not eligible for participation in the C0168T62 study during the study extension participation