Project
Ulcerative Colitis European Registry, A prospective, observational, non-interventional, post-marketing safety surveillance program
Automatically Closed ยท 2010 until 2010
Binek Janek, Knellwolf Christina
Type
Range
Units
Status
Start Date
End Date
Financing
Brief description/objective
The primary objective of this registry is to collect long-term (5 years) safety data including data on the incidence of colorectal cancer, in subjects with moderate to severe active ulcerative colitis (UC) who have been exposed to infliximab (Remicade) and to compare this safety profile to that of UC subjects with similar disease severity treated with standard therapy. Evaluation of safety will be based on reports of (serious) adverse events by the subject and/or treating physician and will be reported on an ongoing basis.
The registry will be offered to physicians treating subjects with UC and who are interested in participating. It will be undertaken on a voluntary basis and will be based in gastroenterology practices and academic institutions.