RecruitingNot ApplicableNCT06298188

Risankizumab in Children With Crohn's Disease (RisaKids)

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


Sponsor

Shaare Zedek Medical Center

Enrollment

90 participants

Start Date

Oct 31, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 6 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (RisaKids) collects real-world data on how well risankizumab — an immunotherapy drug that targets inflammation — works in children with Crohn's disease, a chronic inflammatory bowel condition. **You may be eligible if...** - Your child is under 18 years old with a confirmed diagnosis of Crohn's disease - Your child has already started risankizumab treatment (at least one dose), either alone or in combination with other Crohn's medications **You may NOT be eligible if...** - There are no formal exclusion criteria for this study — all children meeting the above criteria are welcome Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRisankizumab

Risankizumab


Locations(1)

Shaare Zedek Medical Center

Jerusalem, Israel

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NCT06298188


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