COMPARE - Pediatric Inflammatory Bowel Disease (PIBD)
Recruiting
Observational Study
Ulcerative Colitis, Pediatric
Inflammatory Bowel Diseases
Crohn Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 1 – 18
- Sex
- Any
- Study type
- Observational
- Participants needed
- 1,100 (estimated)
- Sponsor
- University of North Carolina, Chapel Hill · Other
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 …
Contacts