PI-SQ Study: How Children’s Bodies Process Injected Medicines for Crohn’s Disease and Ulcerative Colitis
Phase: Recruiting
Condition(s): Inflammatory Bowel Disease
What Is the Purpose of This Study?
This is a prospective, multicenter investigation of pediatric IBD (Crohn's disease and ulcerative colitis) subjects starting ustekinumab, risankizumab or adalimumab induction with longitudinal biospecimen and patient reported outcome collection. The primary objective is to construct a real-world, pediatric-specific pharmacokinetic model for ustekinumab, risankizumab and adalimumab for pediatric patients with IBD.
Who Can Take Part in This Study?
People who may be eligible for this study are:
- Diagnosed with inflammatory bowel disease (IBD)
- Starting one of the following medications: adalimumab, ustekinumab, risankizumab, upadacitinib or guselkumab
- Ages 2-22 years
What Will Happen During This Study?
- After screening for eligibility, patients will be assigned to one of the cohorts based on the medication they’re starting.
- Participants will complete surveys and collect additional blood and stool samples for up to 1 year depending on their medication.
Principal Investigator
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