Status:
NOT_YET_RECRUITING
COMPARE - Pediatric Inflammatory Bowel Disease (PIBD)
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Duke Clinical Research Institute
Conditions:
Ulcerative Colitis, Pediatric
Inflammatory Bowel Diseases
Eligibility:
All Genders
1-18 years
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 pediatri...
Detailed Description
COMPARE is a multi-center, observational cohort study that includes both prospective and retrospective components and two patient population cohorts-Crohn's disease (CD) and ulcerative colitis (UC). T...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
1100 Patients enrolled
Trial Details
Trial ID
NCT07198113
Start Date
November 1 2025
End Date
September 1 2028
Last Update
September 30 2025
Active Locations (2)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
2
Duke Health System
Durham, North Carolina, United States, 27701