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JUSTIFY

Efficacy of Ustekinumab for the Treatment of Bio-Naïve Moderate-to-Severe Crohn’s Disease Patients: Real-World Data

 

PI: Talat Bessissow, McGill University

 

Co-Investigators
Dr. Joannie Ruel, Université de Sherbrooke
Dr. Christopher Ma, University of Calgary
Dr. Remo Panaccione, University of Calgary
Dr. Brian Bressler, University of British Columbia
Dr. Vipul Jairath, Western University
Dr. Neeraj Narula, McMaster University

 

Purpose

To assess the rate of clinical remission at 12 months of treatment with UST

 

Study Design

Retrospective multicentre observational cohort study evaluating the real-world efficacy of UST for Canadian patients with moderate-to-severe Crohn’s disease that have not been exposed to a previous biologic agent.

 

Participating Sites

TBD

 

Ustekinumab (UST), a monoclonal antibody that blocks the P40 subunit that is shared between interleukin (IL)12 and 23 is approved by health authorities for the treatment of Crohn’s disease. It is well known that bio-naïve patients have better remission rates than those with previous exposure to other biologics. However, in most jurisdictions, UST cannot be used in bio-naïve patients because of limitations from payers. A robust Real-world study evaluating the efficacy of UST in bio-naïve CD patients will inform clinical practice and inform about the positioning of UST with regards to other biologics.

 

For more information on Inclusion & Exclusion Criteria, click here.

 

Targets

Anticipated sample size: 150
Anticipated start: Fall 2020
Anticipated end: Fall 2021

Reimbursement provided on a per patient basis. Additional sites are welcome! Please contact Talat Bessissow at talat.bessissow@mcgill.ca