Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-18

Study Completion Date

2022-09-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intensified Infliximab Induction

Infliximab 10mg/kg at Week 0 and Week 1

Group Type ACTIVE_COMPARATOR

Infliximab

Intervention Type DRUG

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

Accelerated Infliximab Induction

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

Group Type ACTIVE_COMPARATOR

Infliximab

Intervention Type DRUG

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

Standard Infliximab Induction

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

Group Type ACTIVE_COMPARATOR

Infliximab

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Remicade

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No