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Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis

NCT02770040 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2024-10-08

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Peter De Cruz, MBBS PhD FRACP · Austin Health, Melbourne

  • Matthew C Choy, MBBS BMedSci FRACP · Austin Health, Melbourne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-18
Primary Completion
2021-10-01
Completion
2022-09-07

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02770040 on ClinicalTrials.gov