Risankizumab in Children With Crohn's Disease (RisaKids)
1 other identifier
interventional
90
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2023
CompletedFirst Posted
Study publicly available on registry
March 7, 2024
CompletedStudy Start
First participant enrolled
October 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
December 3, 2024
February 1, 2024
1.9 years
October 24, 2023
November 27, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Co-primary outcomes: Complete remission at end of remission (weeks 12 and week 54)
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)
Through study completion, approximately 3 years
Study Arms (1)
Risankizumab
EXPERIMENTALInduction regimen: 0,4,8 IV and then every 8 weeks sc
Interventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shaare Zedek Medical Center
Jerusalem, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Pediatric Gastroenterologist, Principal Investigator
Study Record Dates
First Submitted
October 24, 2023
First Posted
March 7, 2024
Study Start
October 31, 2024
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
December 3, 2024
Record last verified: 2024-02