Clinical Trials

Inclusion Criteria

• Adults, 18 years and older
• Hospitalized, with a moderate to severe flare based on the Mayo Scoring System for Assessment of Ulcerative Colitis Activity (Mayo score of equal or greater than 6)
• Treatment naïve to anti TNF agents
• Initiation of infliximab, with or without immunomodulator such as azathioprine
• Ongoing use of immunomodulators such as azathioprine or 6MP is acceptable and remains at the discretion of the treating physician

Exclusion Criteria

• Ongoing or prior treatment with Infliximab or other anti TNF agents
  • Concomitant immunomodulator therapy is acceptable if on a stable dosing for atleast 4 weeks
  • Current medications may be continued at the discretion of the treating physician
• Fulminant colitis or toxic megacolon requiring emergent surgery
• Pregnancy
• Infectious colitis, for example Clostridium difficile or CMV (cytomegalovirus) colitis
• Active infection or abscess
• Untreated latent or active tuberculosis (TB)
  • Those with latent TB who are currently undergoing treatment can be included
  • Please refer to appendix 1 for more information on specific inclusion and exclusion criteria related to TB testing
  • Refer to 1.4.2 of appendix 1 for TB screening questions
• Active malignancy
• Active or history of Congestive Heart failure (CHF) or those who have received treatment for CHF
• Active or history of Multiple Sclerosis (MS), or those who have received treatment for MS
• Prisoners, institutionalized individuals, and individuals who are not capable of giving informed consent
• Other criteria that is the judgement of the investigator