Study of Novel Therapeutics for Acute Remedy of Colitis

Launched by BRIGHAM AND WOMEN'S HOSPITAL · May 14, 2024

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Eligibility criteria

• Inclusion Criteria:
• • Severe outpatient or hospitalized for an acute UC flare
• • Ability to give consent
• • Patients with a confirmed diagnosis of UC for \> 3 months
• • History of ≥ 15 cm of colonic involvement as confirmed by colonoscopy
• • Total Mayo score of \> 6
• • Patients with primary sclerosing cholangitis are eligible to enroll
• • Patients will have failed 3 days of IV steroids or 5 days of oral prednisone 30 mg or greater for 5 days and still having a SCCAI of \> 6
• • Anticipated to be administered ustekinumab, vedolizumab or 6-MP/azathioprine as their subsequent medication.
• Exclusion Criteria:
• • History of uncontrolled hypertension with systolic BP \> 140 and systolic BP \> 90
• • Chronic kidney disease as defined by GFR \<60mL/min
• • Impaired hepatic function (transaminases elevated \> 2.5 x ULN) unless due to PSC
• • Evidence of C. difficile (Negative test result within 1 month is acceptable)
• • Infectious Colitis or drug induced colitis
• • Crohn's Disease or Indeterminate colitis
• • Decompensated liver disease
• • Patients who are pregnant or breastfeeding
• • Patients who have a confirmed malignancy or cancer within 5 years
• • Congenital or acquired immunodeficiencies
• • Other comorbidities including: Diabetes mellitus, systemic lupus
• • Participation in a therapeutic clinical trial in the preceding 30 days or simultaneously during this trial
• • Patients with a history or risk of cardiovascular conditions, including arrhythmia, long QT syndrome, congestive heart failure, stroke, or coronary artery disease
• • Prohibited medications: Vitamin C, prednisone, immune modulators (including but not limited to, mycophenolate mofetil, tacrolimus, cyclosporine, thalidomide, interleukin-10 and interleukin-11) and anti-TNF agents within the past six weeks
• • Patients are planned to be started on a fast- acting medication including an anti-TNF agent (infliximab, adalimumab, golimumab, certolizumab), on a JAKi (upadacitinib, tofacitinib)