Risankizumab in Children With Crohn's Disease (RisaKids)
ConditionCrohn Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorShaare Zedek Medical Center
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Risankizumab
DrugRisankizumab
Treatment groups
90 Participants
are divided into 1 treatment groupGroup A: RisankizumabExperimental treatment 1 intervention
Trial outcomes
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)
Time frame
Through study completion, approximately 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov