Actively Recruiting
COMPARE - Pediatric Inflammatory Bowel Disease (PIBD)
Led by University of North Carolina, Chapel Hill · Updated on 2026-04-17
1100
Participants Needed
4
Research Sites
147 weeks
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
COMPARE - Pediatric Inflammatory Bowel Disease (PIBD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age less than 18 years at study enrollment
- Diagnosis of Crohn's disease, ulcerative colitis, or indeterminate colitis by standard criteria
- Prior non-response or loss of response to one or more anti-TNF agents
- Planning to start treatment with vedolizumab, ustekinumab, risankizumab, guselkumab, mirikizumab, tofacitinib, or upadacitinib (including biosimilars or generics)
- Ability to provide child assent if required and parental consent in English or Spanish
You will not qualify if you...
- Plans to change care to a different center within 1 year
- Prior use of any comparator agent; only first-time users of these medications are eligible
- Contraindications to any treatments under study
- Patients with ulcerative colitis or indeterminate colitis who have had a colectomy
- Patients with a current ostomy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
2
Atrium Health
Charlotte, North Carolina, United States, 28203
Actively Recruiting
3
Duke Health System
Durham, North Carolina, United States, 27701
Actively Recruiting
4
University of Pittsburgh Medical Center, Children's Hospital
Pittsburgh, Pennsylvania, United States, 15222
Actively Recruiting
Research Team
D
Duke Clinical Research Institute COMPARE Call Center
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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