COMPARE — Newer IBD treatments in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

COMPARE is a multicenter observational cohort study with both prospective and retrospective components that enrolls children under 18 with Crohn's disease or ulcerative colitis who are anti‑TNF refractory. Participants starting non‑anti‑TNF biologics or small molecules (including IL‑23 agents, vedolizumab, ustekinumab, and JAK inhibitors) will be followed during routine care. Patient‑reported outcome surveys are collected at baseline, every two months for the first year, and every six months in years two and three, with clinical data drawn from medical records. The primary analyses compare the two most frequently used drug classes in each cohort, and secondary analyses include any class with at least 50 initiators.

Why it matters

Who can join: the full rules

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

Where it's running

• University of North Carolina at Chapel Hill
  Chapel Hill, North Carolina, United States Recruiting
• Atrium Health
  Charlotte, North Carolina, United States Recruiting
• Duke Health System
  Durham, North Carolina, United States Recruiting
• University of Pittsburgh Medical Center, Children's Hospital
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Michael D Kappelman, MD — Universty of North Carolina, Chapel Hill
• Study coordinator: Duke Clinical Research Institute COMPARE Call Center
• Email: COMPARE@dm.duke.edu
• Phone: 833-850-2848

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.