Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis (NCT02770040) | Clinical Trial Compass
CompletedPhase 4
Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis
Australia138 participantsStarted 2016-07-18
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (Inflixi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.