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

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.

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