Risankizumab in Children With Crohn's Disease (RisaKids) - Trial NCT06298188
Access comprehensive clinical trial information for NCT06298188 through Pure Global AI's free database. This phase not specified trial is sponsored by Shaare Zedek Medical Center and is currently Not yet recruiting. The study focuses on Crohn Disease. Target enrollment is 90 participants.
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Study Focus
Sponsor & Location
Shaare Zedek Medical Center
Timeline & Enrollment
N/A
Mar 01, 2024
Oct 01, 2026
Primary Outcome
Co-primary outcomes: Complete remission at end of remission (weeks 12 and week 54)
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06298188
Non-Device Trial