Risankizumab in Children With Crohn's Disease (RisaKids)
NCT ID: NCT06298188
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2024-10-31
2026-10-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Risankizumab
Induction regimen: 0,4,8 IV and then every 8 weeks sc
Risankizumab
Risankizumab
Interventions
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Risankizumab
Risankizumab
Eligibility Criteria
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Inclusion Criteria
* 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.
6 Years
18 Years
ALL
No
Sponsors
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Shaare Zedek Medical Center
OTHER
Responsible Party
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Prof. Amit Assa
Pediatric Gastroenterologist, Principal Investigator
Locations
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Shaare Zedek Medical Center
Jerusalem, , Israel
Countries
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Central Contacts
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Other Identifiers
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RisaKids
Identifier Type: -
Identifier Source: org_study_id