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

Ulcerative Colitis Clinical Trial

Official title:
A Multicenter International Study of the Long-term Safety of Infliximab (REMICADE) in Ulcerative Colitis

Clinical Trial 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.

Clinical Trial Description

This is a long term, multicenter, international safety study to evaluate targeted long-term safety information on patients who have participated in infliximab(Remicade) clinical studies in ulcerative colitis that require long-term safety follow-up. All patients who received at least one dose of study drug (infliximab or placebo) in the primary studies (C0168T37 ,C0168T46, C0168T72) are eligible to participate in this long-term safety follow-up study (C0168T62). Patients will begin participation in C0168T62 at the time of their last safety visit in the primary study and will be followed for 5 years. No study agent will be administered. Information on deaths, serious infections, new malignancies (including colorectal cancer) and new autoimmune diseases and surgical procedures (including colectomy) and hospitalizations for the treatment of ulcerative colitis will be collected. Information about possible delayed allergic reactions (possible fever, rash, fatigue, joint pain) will also be collected if patients received infliximab after the end of the primary study. In addition, data on dysplasia of the colon will be collected from patients who were identified in the primary study to be at high-risk for colon cancer and were required per protocol to undergo a follow-up colonoscopy as part of long-term safety follow-up. All adverse events, including non-serious adverse events, will also be collected. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00207688
Study type Observational
Source Janssen Research & Development, LLC
Contact
Status Completed
Phase
Start date August 31, 2004
Completion date September 9, 2015
View Details
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