Over one-third of patients with ‘acute severe colitis (ASUC)’ will not respond well to the intravenous steroids that doctors will use to manage the condition. This poor response is not well understood. Doctors have noted that some patients may lose large amounts of the drug infliximab in their fecal matter, and this may be the reason it does not work effectively. Attempts to overcome this have included high and frequent doses of infliximab in order to accelerate induction, although how well this works is unclear. There has previously been a small study of only 50 patients done on this, but until now a robust and larger-scale comparison of the two infliximab induction treatment strategies has been lacking.
A sub-study with blood, stool and biopsy specimens will be used for further research into ASUC.
Investigators will study a cohort of approximately 300 patients hospitalized for ASUC. Participants will be treated at the discretion of their treating physician. It is expected that some participants will be treated with standard versus accelerated infliximab dosing, in addition to other treatment strategies.
The study began on November 10th 2018, and is estimated to be completed by July 2021.
- Patients 18-80 years of age
- UC or IBD-unspecified (IBDU) diagnosed according to standard criteria
- Active disease defined as Simple Clinical Colitis Activity Index > 2 (day/night bowel frequency, urgency with defecation, blood in stool, general well-being, and extracolonic features)
- Admitted to the hospital
- Initiating intravenous corticosteroid therapy or medical rescue therapy
- Patients whose disease is currently dormant
- Inability to provide informed consent
- Prior colitis related surgery including J-pouch or stoma
- Non-IBD related hospital admission
- Women who are pregnant (excluded from the specimen substudy only)
- Non – English speaking
Sponsors / Collaborators
This study is sponsored by Johns Hopkins University, Massachusetts General Hospital, University of Maryland, College Park, University of North Carolina, Chapel Hill and Icahn School of Medicine at Mount Sinai. The Principal Investigators are Joanna MP Melia, MD of John Hopkins University and Ashwin Ananthakrishnan, MD of Massachusetts General Hospital.
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