Clinical Research Directory

Risankizumab in Children With Crohn's Disease (RisaKids)

Sponsor: Shaare Zedek Medical Center

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.

Official title: Risankizumab in Children With Crohn's Disease (RisaKids): A Multi-center PORTO Group Prospective Study

Key Details

Conditions

Interventions

Locations (1)