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NCT07198113 · ClinicalTrials.gov registry record
COMPARE - Pediatric Inflammatory Bowel Disease (PIBD)
A clinical trial, sponsored by University of North Carolina, Chapel Hill.
- Recruiting
- Registry status
- 1,100
- Enrollment target
NCT07198113: Recruiting study, sponsored by University of North Carolina, Chapel Hill.
NCT07198113 is a clinical trial that is actively recruiting participants, run by University of North Carolina, Chapel Hill. The registered enrollment target is 1,100 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07198113 is actively recruiting participants, sponsored by University of North Carolina, Chapel Hill.
- RECRUITING
- Registry status
- 1,100 participants
- Enrollment target
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.
Primary Outcome
The TUMMY CD patient reported outcome (PRO) has been developed and is undergoing validation. For our CD cohort, we will collect data on both the TUMMY-CD and the PROMIS IBD PROs. If TUMMY-CD is proven to be a reliable and valid PRO by the time of our data analysis, we will utilize this as our primary PRO. Otherwise, we will rely on PROMIS IBD PROs. Change will be calculated as the difference between baseline and post-baseline scores, with higher scores reflecting greater symptom severity.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,100 participants |
| Start Date | 2025-11-01 |
| Est. Completion | 2028-09 |
What NCT07198113 shows while recruiting
NCT07198113 is an observational study that tracks outcomes without assigning an intervention. Its 1,100 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT07198113 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07198113 about?
NCT07198113 is a clinical study titled "COMPARE - Pediatric Inflammatory Bowel Disease (PIBD)". 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 (TN...
What is the current status of trial NCT07198113?
This trial is currently recruiting. The enrollment target is 1,100 participants. The study started on 2025-11-01. Estimated completion is 2028-09.
Who is sponsoring clinical trial NCT07198113?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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