NCT07198113Recruiting
COMPARE - Pediatric Inflammatory Bowel Disease (PIBD)
Clinical Outcomes of Medications Post Anti-TNF: Researching Effectiveness in Pediatric IBD
Source: ClinicalTrials.gov · Last updated 17 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1100 (estimated)
- First submitted
- 19 Sept 2025
- Start date
- 1 Nov 2025
- Primary completion date
- Sept 2028
- Lead sponsor
- University of North Carolina, Chapel Hill
- NCT number
- NCT07198113
What you commit to
- Study type: Observational
- Planned participants: 1100
- From 1 Nov 2025 to the primary completion date, Sept 2028
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior use of a comparator agent (i.e., only patients starting their first comparator medication as monotherapy following anti-TNF will be eligible)
Other
- Plans to change care to a different center within 1 year
- Contraindication to any of the treatments under investigation
- Patients with UC or IBD-U who have undergone colectomy
- Patients with current ostomy
Who the study is looking for
- 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
Age in the registry: 1 year to 18 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| Atrium Health Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| Duke Health System Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| University of Pittsburgh Medical Center, Children's Hospital Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.