Risankizumab in Children With Crohn's Disease (RisaKids)

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Crohn Disease

Clinical Trial Details

NCT number	NCT06298188
Study type	Interventional
Source	Shaare Zedek Medical Center
Contact	Chen Shubeli
Phone	97225645254
Email	chenn@szmc.org.il
Status	Not yet recruiting
Phase	N/A
Start date	March 2024
Completion date	October 2026

View Details

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