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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

May 9, 2016
May 12, 2016
July 6, 2016
July 2016
March 2019   (Final data collection date for primary outcome measure)
  • Colectomy free survival [ Time Frame: Day 90 ]
  • Clinical response [ Time Frame: Day 14 ]
    defined as a reduction in the Lichtiger score below 10 with a decrease of at least 3 points
Same as current
Complete list of historical versions of study NCT02770040 on ClinicalTrials.gov Archive Site
  • 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.
  • Differences in daily Lichtiger score [ Time Frame: From day 0 to day 7 ]
  • Steroid free remission [ Time Frame: Day 90 ]
    defined as a Mayo disease activity index score ≤2 with an endoscopic subscore ≤1
  • Endoscopic remission rate [ Time Frame: Day 90 ]
    defined as a Mayo endoscopic subscore of 0
  • Endoscopic remission rate [ Time Frame: 12 months ]
    defined as a Mayo endoscopic subscore of 0
  • Colectomy free survival [ Time Frame: 12 months ]
Same as current
Not Provided
Not Provided
 
Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis
PREDICT UC: Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis - A Randomised Controlled Trial
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Ulcerative Colitis
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: Intensified Infliximab Induction
    Infliximab 10mg/kg at Week 0 and Week 1
    Intervention: Drug: Infliximab
  • Active Comparator: Accelerated Infliximab Induction
    Infliximab 5mg/kg at Week 0, Week 1 and Week 3
    Intervention: Drug: Infliximab
  • Active Comparator: Standard Infliximab Induction
    Infliximab 5mg/kg at Week 0, Week 2 and Week 6
    Intervention: Drug: Infliximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
138
Same as current
September 2019
March 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
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
Australia
 
 
NCT02770040
HREC/14/Austin/595
Yes
Not Provided
Plan to Share IPD: No
Dr Peter De Cruz, Austin Health
Austin Health
University of Melbourne
Principal Investigator: Peter De Cruz, MBBS PhD FRACP Austin Health, Melbourne
Principal Investigator: Matthew C Choy, MBBS BMedSci FRACP Austin Health, Melbourne
Austin Health
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP