Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 14 October 2024
• Main ID: NCT02770040
• Date of registration: 09/05/2016
• Prospective Registration: Yes
• Primary sponsor: Austin Health
• Public title: Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis PREDICT UC
• Scientific title: PREDICT UC: Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis
• Date of first enrolment: July 18, 2016
• Target sample size: 138
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02770040
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Australia

Contacts

• Name: Matthew C Choy, MBBS BMedSci FRACP
• Affiliation: Austin Health, Melbourne

• Name: Peter De Cruz, MBBS PhD FRACP
• Affiliation: Austin Health, Melbourne

Key inclusion & exclusion 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


Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: Infliximab

Primary Outcome(s)

Clinical response by day 7 [Time Frame: Day 7]

Secondary Outcome(s)

Colectomy by Day 7 [Time Frame: From Day 0 to Day 7]

Time to clinical response [Time Frame: Up to 3 months]

Secondary ID(s)

HREC/14/Austin/595

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Melbourne