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
Study 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?
Eligibility
Sex
ALL
Min age
—
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
Male or female, 18 to 80 years old
BWT on IUS \> 3.0mm in the ileum and colonic disease permitted.
Patients naïve to guselkumab.
Stricture phenotype - BWT \> 3 mm, luminal apposition \< 1cm or \< 50% of adjacent normal bowel diameter, and prestenotic dilation of distal ileum. Naïve or anastomotic strictures permitted.
Non-stricture phenotype- ileal CD with no evidence of stricture on IUS, computed tomography enterography (CTE), or magnetic resonance enterography (MRE), ever or fistulizing phenotype.
Exclusion Criteria:
Pregnancy
Ileostomy or colostomy
Significant obesity (BMI \> 35)
Contraindications to initiating GUS such as active infection.
Active malignancy within five years.
Conditions with fibrosis involving other organs such as lungs, kidneys, brain, or skin.
Primary outcome measure(s)
Proportion of patients with IUS response in patients with and without Crohn's disease strictures on Guselkumab therapy over 1 year — 52 weeks IUS response: decreased bowel wall thickness of \> 25%, or \> 2.0mm, or \> 1.0mm and one colour Doppler signal reduction.
Transmural remission: Bowel wall thickness \< 3mm, colour Doppler signal (modified Limberg grade 0), normal stratification, normal inflammatory fat, and no complications (abscess, phlegmon, fistulas).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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