- Subjects who completed induction studies A3921094 or A3921095 and were classified as
not meeting clinical response criteria; OR
- Subjects who completed maintenance study A3921096 or who discontinued treatment early
in Study A3921096 due to treatment failure.
- Subjects who had a major protocol violation in Study A3921094, A3921095 or A3921096.
- Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious
colitis, or clinical findings suggestive of Crohn's disease.
- Subjects who have had surgery for ulcerative colitis or in the opinion of the
investigator, are likely to require surgery for ulcerative colitis during the study