Actively Recruiting
Risankizumab in Children With Crohn's Disease (RisaKids)
Led by Shaare Zedek Medical Center · Updated on 2024-12-03
90
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this observational study is to to prospectively explore the real life short (12 weeks) and longer term (54 weeks) clinical, biochemical and endoscopic outcomes of risankizumab in pediatric CD. This is a 1-year prospective multi-center cohort study of children commencing on risankizumab for pediatric CD with 2 years extension for long-term follow-up. The investigators will record clinical manifestations, blood markers and fecal calprotectin, with monitoring for safety signals including infusion and injection site reactions, pyrexia and infections at various intervals as outlined below. The investigators will also include calprotectin monitoring and fecal sample collection for microbiome and serum samples for drug levels. According to available budget, the investigators will also collect fecal and serum samples for metabolome. Samples collection is optional, thus failure of bio-samples collection will not exclude patients from the study.
CONDITIONS
Official Title
Risankizumab in Children With Crohn's Disease (RisaKids)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children under the age of 18 years
- Patients diagnosed with Crohn's Disease
- Patients who have started risankizumab treatment by their physician, either alone or with other Crohn's Disease medications, at any disease stage
You will not qualify if you...
- There are no exclusion criteria for this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shaare Zedek Medical Center
Jerusalem, Israel
Actively Recruiting
Research Team
N
Nataly Kawazba
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here