COMPARE — Newer IBD treatments in children
Clinical Outcomes of Medications Post Anti-TNF: Researching Effectiveness in Pediatric IBD
This project compares the safety and effectiveness of newer IBD medicines for children with Crohn's disease or ulcerative colitis who did not respond to anti‑TNF treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1100 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Drugs / interventions | vedolizumab, ustekinumab, risankizumab, guselkumab, mirikizumab, tofacitinib, upadacitinib |
| Locations | 4 sites (Chapel Hill, North Carolina and 3 other locations) |
| Trial ID | NCT07198113 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Children under 18 with a diagnosis of Crohn's disease or ulcerative colitis who have had no response or lost response to one or more anti‑TNF agents and are starting one of the listed newer biologic or small‑molecule therapies are ideal candidates.
Not a fit: Patients who are adults, who have previously used the comparator agent, or who plan to change their care center within a year are unlikely to be eligible or to gain from the study's comparative analyses.
Why it matters
Potential benefit: If successful, this work could help clinicians choose the safest and most effective non‑anti‑TNF treatments for children with IBD who failed anti‑TNF therapy.
How similar studies have performed: Similar observational and registry studies in adults and small pediatric cohorts have reported effectiveness for agents like ustekinumab and vedolizumab, but direct head‑to‑head pediatric comparisons remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chapel Hill, North Carolina and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.