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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02770040




Registration number
NCT02770040
Ethics application status
Date submitted
9/05/2016
Date registered
12/05/2016

Titles & IDs
Public title
Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis
Scientific title
PREDICT UC: Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis
Secondary ID [1] 0 0
HREC/14/Austin/595
Universal Trial Number (UTN)
Trial acronym
PREDICT UC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Infliximab

Active comparator: Intensified Infliximab Induction - Infliximab 10mg/kg at Week 0 and Week 1

Active comparator: Accelerated Infliximab Induction - Infliximab 5mg/kg at Week 0, Week 1 and Week 3

Active comparator: Standard Infliximab Induction - Infliximab 5mg/kg at Week 0, Week 2 and Week 6


Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical response by day 7
Timepoint [1] 0 0
Day 7
Secondary outcome [1] 0 0
Time to clinical response
Timepoint [1] 0 0
Up to 3 months
Secondary outcome [2] 0 0
Colectomy by Day 7
Timepoint [2] 0 0
From Day 0 to Day 7

Eligibility
Key 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/07/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/09/2022
Sample size
Target
Accrual to date
Final
138
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Austin Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Melbourne
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter De Cruz, MBBS PhD FRACP
Address 0 0
Austin Health, Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02770040