Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Austin Health
With
University of Melbourne
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis
