COMPARE - Pediatric Inflammatory Bowel Disease (PIBD)

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT07198113
Status
Recruiting
Apply to this trial

Conditions

  • Crohn Disease
  • Inflammatory Bowel Diseases
  • Ulcerative Colitis, Pediatric

Eligibility Criteria

Sex
ALL
Age
1 Year - 18 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Nov 1, 2025
Status verified
Apr 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
1,100 participants (estimated)

Arms

  • Arm: Children with Crohn's disease (CD)
    Pediatric CD patients initiating non-anti-TNF biologics and small molecules that are FDA-approved for adult populations
  • Arm: Children with Ulcerative Colitis (UC)
    Pediatric UC patients initiating non-anti-TNF biologics and small molecules that are FDA-approved for adult populations
  • Arm: Retrospective Safety Analysis
    Retrospective cohort focused on the long-term safety of non-anti-TNF biologics and small molecules that are FDA-approved for adult populations in for CD and or UC. Electronic health record (EHR) data (retrospective cohort) will be collected from medical charts and EHRs at participating institutions.

Primary Outcome Measure

Change in sPCDAI Score for Crohn's Disease [ Time Frame: Each clinic visit (baseline through follow-up, up to 3 years) ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel HillChapel HillNorth Carolina27599
Ajay Gulati, MD
[email protected]
919-962-9900
Atrium HealthCharlotteNorth Carolina28203
Tiffany Linville, MD
[email protected]
704-381-8800
Duke Health SystemDurhamNorth Carolina27701
Annette Babu
[email protected]
919-681-8739
University of Pittsburgh Medical Center, Children's HospitalPittsburghPennsylvania15222
Whitney Sunseri, MD
412-692-5180

Find similar trials in Chapel Hill, NC

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
University of North Carolina at Chapel Hill· Chapel Hill, NCAtrium Health· Charlotte, NCDuke Health System· Durham, NCUniversity of Pittsburgh Medical Center, Children's Hospital· Pittsburgh, PA

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