COMPARE: Pediatric Inflammatory Bowel Disease Study
This study, called COMPARE, is looking at how well newer medications work and how safe they are for children and teenagers (ages 1 to 18) with inflammatory bowel disease (IBD), specifically Crohn's disease or ulcerative colitis. These are children who haven't responded well to previous anti-TNF medications. The study will observe patients already taking medications like vedolizumab (Entyvio™), ustekinumab (Stelara™), risankizumab (Skyrizi™), guselkumab (Tremfya™), or mirikizumab (Omvoh™), tofacitinib (Xeljanz™), or upadacitinib (Rinvoq™). The main goal is to see if these newer treatments improve daily life for patients with IBD, measured by surveys completed over three years. The study plans to include about 1100 participants, but its current status is unclear.
- Study design
- This is an observational study, meaning researchers will watch and collect information from patients already receiving treatment, rather than assigning treatments. It includes both looking back at past records and following patients forward in time.
- What's involved
- You or your child would complete surveys about general health and well-being at the start, every two months for the first year, and then every six months for the next two years.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 36 months (3 years) after starting the study.
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COMPARE - Pediatric Inflammatory Bowel Disease (PIBD)
At a glance
Conditions
Where it's being run
4 sites across 2 statesStudy leadership
- Michael D Kappelman, MD · PRINCIPAL_INVESTIGATOR · Universty of North Carolina, Chapel Hill
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Measure of Crohn's disease (CD) impact on patients' daily lives (TUMMY CD)Baseline, months 2, 4, 6, 8, 10, 12, 18, 24, 30, 36
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.
- Measures of ulcerative colitis (UC) impact on patients' daily lives (TUMMY UC)Baseline, months 2, 4, 6, 8, 10, 12, 18, 24, 30, 36
Description: The TUMMY UC patient reported outcome (PRO) is a validated patient-reported outcome tool designed to assess gastrointestinal symptom burden in children and adolescents with ulcerative colitis (UC). Change will be calculated as the difference between baseline and post-baseline scores, with higher scores reflecting greater symptom severity. Scores range from 0 to 114 with higher values indicating greater symptom burden.
- PROMIS Symptom Measure of Irritable Bowel Disease (IBD)Baseline, months 2, 4, 6, 8, 10, 12, 18, 24, 30, 36
NIH Patient Reported Outcome Measurement Information System (PROMIS) symptoms scale is a disease-specific PRO. Prior validation of the PROMIS IBD measure has demonstrated acceptable internal consistency (Cronbach's alpha of 0.74), as well as discriminative and known groups validity. The PROMIS IBD symptom score has been standardized such that a T score of 50 represents the median score in the reference pediatric IBD population. T scores range from 40 to 80 with higher scores indicating higher symptom burden and a minimal clinically important difference (MCID) of 5. We will not use the PROMIS IBD for measure of UC
- Change in Pediatric PROMIS® Patient-Reported Outcome (PRO) Pain Interference Score for Crohn's Disease and Ulcerative Colitis (CD and UC)Baseline, months 6, 12, 18, 24, 30, 36
Pediatric Patient Reported Outcome Measurement Information System (PROMIS) assesses domains relevant to children and adolescents with CD and UC and their reported pain score. PROMIS Pediatric PROs domains have been standardized such that a T score of 50 represents the median score in the reference pediatric IBD population with higher scores indicating higher symptom burden and minimal clinically important difference (MCID) of 5.
- Change in Pediatric PROMIS® Fatigue Score for Crohn's Disease and Ulcerative Colitis (CD and UC)Baseline, months 6, 12, 18, 24, 30, 36
Pediatric Patient Reported Outcome Measurement Information System (PROMIS) assesses domains relevant to children and adolescents with CD and UC and their reported fatigue score. PROMIS Pediatric PROs domains have been standardized such that a T score of 50 represents the median score in the reference pediatric IBD population with higher scores indicating higher symptom burden and minimal clinically important difference (MCID) of 5.
- Change in Pediatric PROMIS® Anxiety Score for Crohn's Disease and Ulcerative Colitis (CD and UC)Baseline, months 6, 12, 18, 24, 30, 36
Pediatric Patient Reported Outcome Measurement Information System (PROMIS) assesses domains relevant to children and adolescents with CD and UC and their reported anxiety score. PROMIS Pediatric PROs domains have been standardized such that a T score of 50 represents the median score in the reference pediatric IBD population with higher scores indicating higher symptom burden and minimal clinically important difference (MCID) of 5.
- Change in Pediatric PROMIS® Depression Score for Crohn's Disease and Ulcerative Colitis (CD and UC)Baseline, months 6, 12, 18, 24, 30, 36
Pediatric Patient Reported Outcome Measurement Information System (PROMIS) assesses domains relevant to children and adolescents with CD and UC and their reported depression score. PROMIS Pediatric PROs domains have been standardized such that a T score of 50 represents the median score in the reference pediatric IBD population with higher scores indicating higher symptom burden and minimal clinically important difference (MCID) of 5.
- Change in sPCDAI Score for Crohn's DiseaseEach clinic visit (baseline through follow-up, up to 3 years)
The short Pediatric Crohn's Disease Activity Index (sPCDAI) is a validated tool to assess disease activity in children with Crohn's disease. It is based on clinical symptoms, physical examination findings, and laboratory values. Scores range from 0 to 90, with higher scores indicating greater disease activity. The outcome will be measured as the mean change in sPCDAI score from baseline to follow-up. T Scores ≤15 indicate remission, \> 15-29 mild disease and ≥30 indicate moderate to severe disease
- Change in Pediatric Ulcerative Colitis Activity Index (PUCAI) ScoreEach clinic visit (baseline through follow-up, up to 3 years)
The Pediatric Ulcerative Colitis Index (PUCAI) is a patient-centered, 6-item measure assessing abdominal pain, stool characteristics, and patient functioning. Scores ranging from 0 - 85 with higher scores indicate more disease activity. A cut-point of \<10 indicates remission, ≥10 to 34 mild disease, ≥35-65 moderate disease, and ≥65 severe disease. Response is defined as a reduction of ≥ 20 points.