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

Primary Purpose

Ulcerative Colitis

Status

Completed

Phase

Phase 4

Locations

Australia

Study Type

Interventional

Intervention

Infliximab

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Acute Severe Ulcerative Colitis, Steroid Refractory Ulcerative Colitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Austin Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Intensified Infliximab Induction

Accelerated Infliximab Induction

Standard Infliximab Induction

Arm Description

Infliximab 10mg/kg at Week 0 and Week 1

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to clinical response

Colectomy by Day 7

Full Information

NCT ID

NCT02770040

First Posted

May 9, 2016

Last Updated

May 30, 2023

Sponsor

Austin Health

Collaborators

University of Melbourne

1. Study Identification

Unique Protocol Identification Number

NCT02770040

Brief Title

Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis

Acronym

PREDICT UC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

July 18, 2016 (Actual)

Primary Completion Date

October 1, 2021 (Actual)

Study Completion Date

September 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Austin Health

Collaborators

University of Melbourne

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis

Keywords

Acute Severe Ulcerative Colitis, Steroid Refractory Ulcerative Colitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

138 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intensified Infliximab Induction

Arm Type

Active Comparator

Arm Description

Infliximab 10mg/kg at Week 0 and Week 1

Arm Title

Accelerated Infliximab Induction

Arm Type

Active Comparator

Arm Description

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

Arm Title

Standard Infliximab Induction

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Infliximab

Other Intervention Name(s)

Remicade

Intervention Description

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

Primary Outcome Measure Information:

Title

Clinical response by day 7

Description

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

Time Frame

Day 7

Secondary Outcome Measure Information:

Title

Time to clinical response

Time Frame

Up to 3 months

Title

Colectomy by Day 7

Time Frame

From Day 0 to Day 7

Other Pre-specified Outcome Measures:

Title

Colectomy free survival at 1 month, 3 months and 12 months

Description

Effect estimates between different dose regimens

Time Frame

Up to 12 months

Title

Steroid free remission at 3 months

Description

Defined as a Mayo disease activity index score ≤2 with an endoscopic subscore ≤1

Time Frame

Day 90

Title

Endoscopic remission rates at 3 and 12 months

Description

Defined by a Mayo endoscopic subscore of ≤1

Time Frame

Up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter De Cruz, MBBS PhD FRACP

Organizational Affiliation

Austin Health, Melbourne

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Matthew C Choy, MBBS BMedSci FRACP

Organizational Affiliation

Austin Health, Melbourne

Official's Role

Principal Investigator

Facility Information:

Facility Name

Austin Health

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis

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