COMPARE - Pediatric Inflammatory Bowel Disease (PIBD)

Summary

The purpose of the study is to compare the clinical effectiveness and safety of newer inflammatory bowel disease (IBD) medications in anti-tumor necrosis factor (TNF) refractory patients with pediatric IBD (PIBD). Refractory means that there was no clinical response to anti-tumor necrosis factor (TNF) drugs or that the if there was a response, it is no longer present. The main question this study aims to answer is: Are the newer medications used to treat IBD just as safe and effective for treating IBD in children. Participants will already be taking these newer medications as assigned by their regular health care provider.Participants' care will be managed by their regular healthcare provider as part of usual (standard) care for those with PIBD. While taking these medications, participants will be asked to answer questions about their symptoms and health periodically over the course of the study.

Eligibility

Inclusion Criteria:

* Age \< 18 years at study enrollment
* Diagnosis of CD, UC, or IBD-U by standard diagnostic criteria
* Prior non-response or loss of response to one or more anti-TNF agents
* Planning to initiate treatment with any of the following comparator agents: vedolizumab (α4β7 integrin antibody), ustekinumab (anti-IL-12/23 antibody), risankizumab, guselkumab, or mirikizumab, (IL-23 inhibitors), tofacitinib (JAK inhibitor), and upadacitinib (JAK inhibitor). Biosimilars or generic medications for any of the above will also be allowed and handled/analyzed in an identical manner to originators.
* Ability to provide child assent, if required per regulatory or local institutional guidelines, and parental informed consent in English or Spanish

Exclusion Criteria:

* Plans to change care to a different center within 1 year
* Prior use of a comparator agent (i.e., only patients starting their first comparator medication as monotherapy following anti-TNF will be eligible)
* Contraindication to any of the treatments under investigation
* Patients with UC or IBD-U who have undergone colectomy
* Patients with current ostomy

Conditions4

Locations4 sites

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