Risankizumab in Children With Crohn's Disease (RisaKids)

Condition(s) studied

Investigational drug(s) / intervention(s)

Risankizumab: Risankizumab

Study 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

Primary outcome measure(s)

• Co-primary outcomes: Complete remission at end of remission (weeks 12 and week 54) — Through study completion, approximately 3 years
  Co-primary outcomes: Complete remission at end of remission (weeks 12 and week 54) as defined by the fulfilment of all three criteria: i. Corticosteroids and enteral nutrition free ii. Clinical remission (i.e. PCDAI\<10) iii. CRP lower than 1 mg/dl (may be substituted by ESR if CRP missing)

Trial sites (1)

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