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Ultrasound and Proteomics for Guselkumab Response Assessment in Crohn's Disease (UPGRADE).
Sponsor: University of Calgary
Summary
The goal of this observational study is to evaluate the response of guselkumab in adult patients with Crohn's disease (CD) as measured on intestinal ultrasound (IUS), the relative quantities of CD64 in endoscopic tissue biopsies, and the protein signature in the blood of patients with and without therapy response. The main question it aims to answer is: * What is the proportion of ileal Crohn's disease patients with and without strictures who achieve an intestinal ultrasound response? * What is the quantity of CD64 in tissue in CD patients at baseline and at week 52 with and without IUS response? * Are there proteomic signatures in blood of CD patients that respond to GUS?
Official title: UPGRADE: Ultrasound and Proteomics for Guselkumab Response Assessment in Crohn's Disease.
Key Details
Gender
All
Age Range
Any - 80 Years
Study Type
OBSERVATIONAL
Enrollment
90
Start Date
2025-10-31
Completion Date
2027-11
Last Updated
2025-11-24
Healthy Volunteers
No
Interventions
Guselkumab Subcutaneous
Guselkumab will be prescribed by the patient's primary physician according to approved doses by Health Canada for moderate to severe Crohn's disease. Dosing includes: Induction: 200 mg IV or 400mg sc at Weeks 0, 4, and 8 Maintenance: 100 mg SC every 8 weeks or 200 mg SC every 4 weeks
Locations (1)
University of Calgary
Calgary, Alberta, Canada