COMPARE - Pediatric Inflammatory Bowel Disease (PIBD)
Observational · No treatment assigned · 4 sites · University of North Carolina, Chapel Hill
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Ulcerative Colitis, Pediatric, Inflammatory Bowel Diseases and Crohn Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 1 to 18
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 2 more requirement(s). There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 1100 participants are expected to take part.
- Start date: 2025-11-01.
- Main results expected around 2028-09 (estimate from the record).
- 4 study sites listed (4 marked recruiting) in United States.
Main thing being measured
- Measure of Crohn's disease (CD) impact on patients' daily lives (TUMMY CD) (Baseline, months 2, 4, 6, 8, 10, 12, 18, 24, 30, 36)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Ulcerative Colitis, Pediatric; Inflammatory Bowel Diseases; Crohn Disease |
| Lead sponsor | University of North Carolina, Chapel Hill |
| Collaborators | Patient-Centered Outcomes Research Institute; Duke Clinical Research Institute |
| Enrollment | 1100 (estimated) |
| Start date | 2025-11-01 |
| Primary completion (est.) | 2028-09 |
| First posted | 2025-09-30 |
| Last updated | 2026-04-17 |
| Official title | Clinical Outcomes of Medications Post Anti-TNF: Researching Effectiveness in Pediatric IBD |
| ClinicalTrials.gov ID | NCT07198113 |
Interventions
- None listed
Full eligibility criteria (from the record)
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
Locations (4)
| Site | City | Country | Site status |
|---|---|---|---|
| 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 |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.