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.
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT02770040
Ages eligible for Study
18 Years to 80 Years
Genders eligible for Study
Accepts Healthy Volunteers
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
Participant unable to consent for themselves
Indication for immediate surgery (acute abdomen, perforation of the bowel, haemorrhage)
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
All locations for NCT02770040
Melbourne, Victoria, Australia, 3084
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View full eligibility
Tris trial is registered with FDA with number: NCT02770040. The sponsor of the trial is Austin Health and it is looking for 138 volunteers for the current phase.
Official trial title: PREDICT UC: Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis - A Randomised Controlled Trial
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