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COMPARE - Pediatric Inflammatory Bowel Disease (PIBD)

NCT07198113 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1100

Last updated 2026-04-17

No results posted yet for this study

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 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

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

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • Duke Clinical Research Institute

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Michael D Kappelman, MD · Universty of North Carolina, Chapel Hill

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2028-09-30
Completion
2028-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07198113 on ClinicalTrials.gov