Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06298188
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-07
First Post:
2023-10-24
Brief Title:
Risankizumab in Children With Crohns Disease RisaKids
Sponsor:
Shaare Zedek Medical Center
Organization:
Shaare Zedek Medical Center
Study Overview
Official Title:
Risankizumab in Children With Crohns Disease RisaKids A Multi-center PORTO Group Prospective Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None