Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis

Phase 4

Completed

• Conditions: Ulcerative Colitis
• Interventions: Drug: Infliximab

• Registration Number: NCT02770040
• Lead Sponsor: Austin Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-09
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-12
• Study Start: 2016-07-18
• Primary Completion: 2021-10-01
• Study Completion: 2022-09-07
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensified Infliximab Induction	Infliximab	Infliximab 10mg/kg at Week 0 and Week 1
Standard Infliximab Induction	Infliximab	Infliximab 5mg/kg at Week 0, Week 2 and Week 6
Accelerated Infliximab Induction	Infliximab	Infliximab 5mg/kg at Week 0, Week 1 and Week 3

Primary Outcome Measures

Name	Time	Method
Clinical response by day 7	Day 7	Defined as a reduction in the Lichtiger score below 10 with a decrease of at least 3 points and an improvement in rectal bleeding and stool frequency to ≤4 per day

Secondary Outcome Measures

Name	Time	Method
Colectomy by Day 7	From Day 0 to Day 7
Time to clinical response	Up to 3 months

Trial Locations

Locations (1)

Austin Health; 🇦🇺 Melbourne, Victoria, Australia