Actively Recruiting
Ultrasound and Proteomics for Guselkumab Response Assessment in Crohn's Disease (UPGRADE).
Led by University of Calgary · Updated on 2025-11-24
90
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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?
CONDITIONS
Official Title
Ultrasound and Proteomics for Guselkumab Response Assessment in Crohn's Disease (UPGRADE).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, 18 to 80 years old
- Bowel wall thickness on intestinal ultrasound greater than 3.0 mm in the ileum
- Patients must be new to guselkumab treatment
- Stricture phenotype: bowel wall thickness over 3 mm, luminal narrowing less than 1 cm or less than 50% of normal bowel diameter, with prestenotic dilation of distal ileum
- Non-stricture phenotype: ileal Crohn's disease with no evidence of stricture on ultrasound, CT enterography, or MR enterography
- Colonic disease involvement is allowed
You will not qualify if you...
- Pregnancy
- Presence of ileostomy or colostomy
- Significant obesity with BMI over 35
- Contraindications to starting guselkumab such as active infection
- Active cancer within the past five years
- Fibrotic conditions affecting lungs, kidneys, brain, or skin
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Calgary
Calgary, Alberta, Canada, T3H 1S7
Actively Recruiting
Research Team
C
Cathy Lu, MD
CONTACT
M
Maureen O'Brien
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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