NCT07198113 COMPARE - Pediatric Inflammatory Bowel Disease (PIBD)
| NCT ID | NCT07198113 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Ulcerative Colitis, Pediatric |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,100 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,100 participants in total. It began in 2025-11-01 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Michael D Kappelman, MD
PRINCIPAL INVESTIGATOR
Universty of North Carolina, Chapel Hill
Frequently Asked Questions
Who can join the NCT07198113 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 18 Years, studying Ulcerative Colitis, Pediatric. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07198113 currently recruiting?
Yes, NCT07198113 is actively recruiting participants. Contact the research team at COMPARE@dm.duke.edu for enrollment information.
Where is the NCT07198113 trial being conducted?
This trial is being conducted at Chapel Hill, United States, Charlotte, United States, Durham, United States, Pittsburgh, United States.
Who is sponsoring the NCT07198113 clinical trial?
NCT07198113 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Michael D Kappelman, MD at Universty of North Carolina, Chapel Hill. The trial plans to enroll 1,100 participants.
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