Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis (PREDICT UC)

Austin Health

Status and phase: Completed; Phase 4

Conditions: Ulcerative Colitis

Treatments: Drug: Infliximab

Study type: Interventional

Funder types: Other

Identifiers

NCT02770040

HREC/14/Austin/595

Details and patient eligibility

About

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.

Enrollment: 138 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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138 participants in 3 patient groups

Intensified Infliximab Induction

Active Comparator group

Description:

Infliximab 10mg/kg at Week 0 and Week 1

Treatment:

Drug: Infliximab

Accelerated Infliximab Induction

Active Comparator group

Description:

Infliximab 5mg/kg at Week 0, Week 1 and Week 3

Treatment:

Drug: Infliximab

Standard Infliximab Induction

Active Comparator group

Description:

Infliximab 5mg/kg at Week 0, Week 2 and Week 6

Treatment:

Drug: Infliximab