Risankizumab in Children With Crohn's Disease (RisaKids)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Risankizumab.
- Who it may be relevant to
- Registry conditions: Crohn Disease. Basic parameters: 6 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Risankizumab in Children With Crohn's Disease (RisaKids): A Multi-center PORTO Group Prospective Study
Overview
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.
Interventions
- Drug Risankizumab
Risankizumab
Primary outcome measures
- Co-primary outcomes: Complete remission at end of remission (weeks 12 and week 54) [Time frame: Through study completion, approximately 3 years]
Eligibility criteria
Inclusion criteria
- Children under the age of 18 years,
- Patients diagnosed with CD.
- Patients commenced on risankizumab by treating physician (at least one dose), either alone or in combination with any other CD medications, at any stage of the disease.
Exclusion criteria
\* There will be no exclusion criteria to this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Israel · 1 center
- Shaare Zedek Medical Center — Jerusalem
Identifiers
NCT: NCT06298188 · RisaKids