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

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ClinicalTrials.gov Identifier: NCT02770040
Recruitment Status : Recruiting
First Posted : May 12, 2016
Last Update Posted : July 6, 2016
Sponsor:
Collaborator:
University of Melbourne
Information provided by (Responsible Party):
Dr Peter De Cruz, Austin Health

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Infliximab Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PREDICT UC: Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis - A Randomised Controlled Trial
Study Start Date : July 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Arm Intervention/treatment
Active Comparator: Intensified Infliximab Induction
Infliximab 10mg/kg at Week 0 and Week 1
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
Other Name: Remicade

Active Comparator: Accelerated Infliximab Induction
Infliximab 5mg/kg at Week 0, Week 1 and Week 3
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
Other Name: Remicade

Active Comparator: Standard Infliximab Induction
Infliximab 5mg/kg at Week 0, Week 2 and Week 6
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
Other Name: Remicade




Primary Outcome Measures :
  1. Colectomy free survival [ Time Frame: Day 90 ]
  2. Clinical response [ Time Frame: Day 14 ]
    defined as a reduction in the Lichtiger score below 10 with a decrease of at least 3 points


Secondary Outcome Measures :
  1. Treatment failure [ Time Frame: Up to 12 months ]
    1. Absence of clinical response at day 7
    2. Relapse between day 7 and 90 (defined as a Lichtiger score increase of at least 3 points from the previous value that lasts for at least 3 consecutive days and leads to treatment modification)
    3. A severe adverse event leading to treatment interruption
    4. Colectomy by day 90
    5. Death.

  2. Differences in daily Lichtiger score [ Time Frame: From day 0 to day 7 ]
  3. Steroid free remission [ Time Frame: Day 90 ]
    defined as a Mayo disease activity index score ≤2 with an endoscopic subscore ≤1

  4. Endoscopic remission rate [ Time Frame: Day 90 ]
    defined as a Mayo endoscopic subscore of 0

  5. Endoscopic remission rate [ Time Frame: 12 months ]
    defined as a Mayo endoscopic subscore of 0

  6. Colectomy free survival [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770040


Contacts
Contact: Peter De Cruz, MBBS PhD FRACP +61 3 9496 6845 Peter.DeCruz@austin.org.au
Contact: Matthew C Choy, MBBS BMedSci FRACP +61 3 9496 5000 Matthew.Choy@austin.org.au

Locations
Australia, Victoria
Austin Health Recruiting
Melbourne, Victoria, Australia, 3084
Contact: Kristy Boyd, RN BHS    +613 9496 6845    Kristy.BOYD@austin.org.au   
Sponsors and Collaborators
Austin Health
University of Melbourne
Investigators
Principal Investigator: Peter De Cruz, MBBS PhD FRACP Austin Health, Melbourne
Principal Investigator: Matthew C Choy, MBBS BMedSci FRACP Austin Health, Melbourne

Responsible Party: Dr Peter De Cruz, Head of Inflammatory Bowel Disease Unit, Austin Health
ClinicalTrials.gov Identifier: NCT02770040     History of Changes
Other Study ID Numbers: HREC/14/Austin/595
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dr Peter De Cruz, Austin Health:
Acute Severe Ulcerative Colitis
Steroid Refractory Ulcerative Colitis

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents