Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— PREDICT UC  

Official title:

PREDICT UC: Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02770040
• Other study ID #: HREC/14/Austin/595
• Status: Completed
• Phase: Phase 4
• Start date: July 18, 2016
• Est. completion date: September 7, 2022

Study information

• Verified date: May 2023
• Source: Austin Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: September 7, 2022
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Infliximab
INFLIXIMAB (REMICADE) in the form of a freeze-dried compound is conditioned in 100mg vials. Treatment will first be reconstituted in 250ml isotonic saline solution and infused

Locations

Country	Name	City	State
Australia	Austin Health	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Austin Health	University of Melbourne

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Colectomy free survival at 1 month, 3 months and 12 months	Effect estimates between different dose regimens	Up to 12 months
Other	Steroid free remission at 3 months	Defined as a Mayo disease activity index score =2 with an endoscopic subscore =1	Day 90
Other	Endoscopic remission rates at 3 and 12 months	Defined by a Mayo endoscopic subscore of =1	Up to 12 months
Primary	Clinical response by 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	Day 7
Secondary	Time to clinical response		Up to 3 months
Secondary	Colectomy by Day 7		From Day 0 to Day 7