Clinical Trials

Inclusion criteria:

• Moderate to severe Ulcerative Colitis (UC) defined by a Mayo score (a score used to assess the treatment for UC) of 6 to 12 inclusive, including an endoscopic subscore of 2 or more.
• Must either be currently receiving treatment with, or have a history of having failed to respond to, or have a medical contraindication to at least 1 of the following therapies:
  • oral or intravenous corticosteroids,
  • 6-mercaptopurine and azathioprine OR must either have or have had a history of corticosteroid dependency (ie, an inability to successfully taper corticosteroids without a return of the symptoms of UC) OR required more than 3 courses of corticosteroids in the past year
• No history of latent or active tuberculosis prior to screening
• Positive protective antibody titers to varicella and measles prior to the first administration of study agent

Exclusion criteria:

• Have severe extensive UC that is likely to require a colectomy (surgical removal of the colon) within 12 weeks of study entry
• Have UC limited to the rectum only or to less than 20 cm of the colon
• Presence of a stoma
• Presence or history of a fistula
• Have evidence of Crohn's disease (an inflammatory large intestine disease)
• Previous exposure to anti-tumor necrosis factor therapy