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.
Age range
1 Year – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Measure of Crohn's disease (CD) impact on patients' daily lives (TUMMY CD)
Timeframe: Baseline, months 2, 4, 6, 8, 10, 12, 18, 24, 30, 36
Measures of ulcerative colitis (UC) impact on patients' daily lives (TUMMY UC)
Timeframe: Baseline, months 2, 4, 6, 8, 10, 12, 18, 24, 30, 36
PROMIS Symptom Measure of Irritable Bowel Disease (IBD)
Timeframe: Baseline, months 2, 4, 6, 8, 10, 12, 18, 24, 30, 36
Change in Pediatric PROMIS® Patient-Reported Outcome (PRO) Pain Interference Score for Crohn's Disease and Ulcerative Colitis (CD and UC)
Timeframe: Baseline, months 6, 12, 18, 24, 30, 36
Change in Pediatric PROMIS® Fatigue Score for Crohn's Disease and Ulcerative Colitis (CD and UC)
Timeframe: Baseline, months 6, 12, 18, 24, 30, 36
Change in Pediatric PROMIS® Anxiety Score for Crohn's Disease and Ulcerative Colitis (CD and UC)
Timeframe: Baseline, months 6, 12, 18, 24, 30, 36
Duke Clinical Research Institute COMPARE Call Center
Change in Pediatric PROMIS® Depression Score for Crohn's Disease and Ulcerative Colitis (CD and UC)
Timeframe: Baseline, months 6, 12, 18, 24, 30, 36
Change in sPCDAI Score for Crohn's Disease
Timeframe: Each clinic visit (baseline through follow-up, up to 3 years)
Change in Pediatric Ulcerative Colitis Activity Index (PUCAI) Score
Timeframe: Each clinic visit (baseline through follow-up, up to 3 years)