Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis

• Status: Active, not recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to identify whether an Accelerated or Intensified Infliximab induction regimen is superior to Standard induction in Acute Severe Ulcerative Colitis in an open label multi-centre randomised controlled trial.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Austin Health
• Collaborator: University of Melbourne
• Treatments: Infliximab

Criteria

Inclusion Criteria:

• Age >18 years old

• Diagnosis of Ulcerative Colitis

• Acute Severe Colitis according to the Truelove and Witt's Criteria

• Steroid refractory according to the Oxford Criteria

Exclusion Criteria:

• Participant unable to consent for themselves

• Indication for immediate surgery (acute abdomen, perforation of the bowel, haemorrhage)

• Crohn's disease

• Participants with enteric infection confirmed on stool microscopy, culture or toxin

• Haemodynamic instability (mean arterial pressure <60) and not responsive to fluids

• Participants with clinically significant Cytomegalovirus infection (positive inclusion bodies, immunohistochemistry and signs of viraemia such as fever and abnormal liver function tests)

• Participants who are pregnant or currently breast-feeding

• Participants with current malignancy, excluding basal cell carcinoma

• Participants with flat low or high grade colonic dysplasia; sporadic adenomas permitted

• Participants with serious co-morbidities including: Immunodeficiency; Myocardial infarction or acute stroke within the last 3 months; Moderate or severe heart failure (New York Heart Association class III or IV); Active or suspected tuberculosis; Renal failure; Hepatic failure; other severe infections

• Participants with history of hypersensitivity to infliximab or infliximab biosimilar

• Participants who have received other immunosuppressive agents including but not limited to: Anti-TNF therapies within 3 months of screening (Infliximab, Infliximab biosimilar, Golimumab, Etanercept, Certolizumab or Adalimumab); Anti-integrins (Vedolizumb, Etrolizumab) within 4 months of screening; Calcineurin inhibitors (Cyclosporine, Tacrolimus) within 4 weeks of screening; T or B cell depleters (Rituximab, Alemtuzumab) within 12 months of screening; other investigational agents (eg. Ustekinumab) within 6 months of screening