Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis

NCT02770040 | Completed Phase 4 DMC

• 1 other identifier: HREC/14/Austin/595
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Keywords

Acute Severe Ulcerative Colitis; Steroid Refractory Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time to clinical response

  Up to 3 months

• Colectomy by Day 7

  From Day 0 to Day 7

Other Outcomes (3)

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

  Up to 12 months

• Steroid free remission at 3 months

  Day 90

• Endoscopic remission rates at 3 and 12 months

  Up to 12 months

Study Arms (3)

Intensified Infliximab Induction

ACTIVE COMPARATOR

Infliximab 10mg/kg at Week 0 and Week 1

Drug: Infliximab

Accelerated Infliximab Induction

ACTIVE COMPARATOR

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

Drug: Infliximab

Standard Infliximab Induction

ACTIVE COMPARATOR

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

Drug: Infliximab

Interventions

Infliximab 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

Also known as: Remicade

Accelerated Infliximab Induction; Intensified Infliximab Induction; Standard Infliximab Induction

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Austin Health: lead
• University of Melbourne: collaborator

Study Sites (1)

Austin Health

Melbourne, Victoria, 3084, Australia

Location

Related Publications (1)

• Choy MC, Li Wai Suen CFD, Con D, Boyd K, Pena R, Burrell K, Rosella O, Proud D, Brouwer R, Gorelik A, Liew D, Connell WR, Wright EK, Taylor KM, Pudipeddi A, Sawers M, Christensen B, Ng W, Begun J, Radford-Smith G, Garg M, Martin N, van Langenberg DR, Ding NS, Beswick L, Leong RW, Sparrow MP, De Cruz P. Intensified versus standard dose infliximab induction therapy for steroid-refractory acute severe ulcerative colitis (PREDICT-UC): an open-label, multicentre, randomised controlled trial. Lancet Gastroenterol Hepatol. 2024 Nov;9(11):981-996. doi: 10.1016/S2468-1253(24)00200-0. Epub 2024 Sep 2.

  PMID: 39236736 RESULT

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Peter De Cruz, MBBS PhD FRACP

  Austin Health, Melbourne

  PRINCIPAL INVESTIGATOR

• Matthew C Choy, MBBS BMedSci FRACP

  Austin Health, Melbourne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Inflammatory Bowel Disease Unit

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 12, 2016
• Study Start: July 18, 2016
• Primary Completion: October 1, 2021
• Study Completion: September 7, 2022
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)