Ulcerative Colitis, PediatricCOMPARENCT07198113
COMPARE - Pediatric Inflammatory Bowel Disease (PIBD)
An observational study of Ulcerative Colitis, Pediatric and Inflammatory Bowel Diseases, run by University of North Carolina, Chapel Hill at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Ulcerative Colitis, Pediatric, Inflammatory Bowel Diseases, Crohn Disease
- How many people
- 1,100 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Nov 2025to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with Crohn's disease (CD) or ulcerative colitis (UC) whose disease is refractory to anti-TNF therapy
Who may be able to join
- 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 antibody), ustekinumab (anti-IL-12/23 antibody), risankizumab, guselkumab, or mirikizumab, (IL-23 inhibitors), tofacitinib (JAK inhibitor), and upadacitinib (JAK inhibitor). Biosimilars or generic medications for any of the above will also be allowed and handled/analyzed in an identical manner to originators.
- Ability to provide child assent, if required per regulatory or local institutional guidelines, and parental informed consent in English or Spanish
Who cannot join
- Plans to change care to a different center within 1 year
- Prior use of a comparator agent (i.e., only patients starting their first comparator medication as monotherapy following anti-TNF will be eligible)
- Contraindication to any of the treatments under investigation
- Patients with UC or IBD-U who have undergone colectomy
- Patients with current ostomy
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Ajay Gulati, MD, 919-962-9900, ajay_gulati@med.unc.edu
- Recruiting
Atrium Health
Charlotte, North Carolina, 28203
Tiffany Linville, MD, 704-381-8800, pediatricresearch@atriumhealth.org
- Recruiting
Duke Health System
Durham, North Carolina, 27701
Annette Babu, 919-681-8739, annette.babu@duke.edu
- Recruiting
University of Pittsburgh Medical Center, Children's Hospital
Pittsburgh, Pennsylvania, 15222
Whitney Sunseri, MD, 412-692-5180
About this study
Official title: Clinical Outcomes of Medications Post Anti-TNF: Researching Effectiveness in Pediatric IBD
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.
Read the detailed description
COMPARE is a multi-center, observational cohort study that includes both prospective and retrospective components and two patient population cohorts-Crohn's disease (CD) and ulcerative colitis (UC). The study will recruit pediatric IBD patients initiating non-anti-TNF biologics and small molecules that are FDA-approved for adult populations. The primary analyses in each cohort will compare the two most frequently used classes, with all IL-23 agents analyzed as a single class. Secondary comparisons will be conducted for any classes initiated by at least 50 participants. The investigators will also perform a retrospective cohort study using EHR data extracted from participating sites.
IL-23 agents could be any of the following medications:
- Vedolizumab (trade name Entyvio™)
- Ustekinumab (trade name Stelara™)
- Risankizumab (trade name Skyrizi™)
- Guselkumab (trade name Tremfya™)
- Mirikizumab (trade name Omvoh™)
- Tofacitinib (trade name Xeljanz™)
- Upadacitinib (trade name Rinvoq™)
While taking these medications, participants (or parent/caregiver proxies) will complete patient-reported outcome surveys (PROS) at baseline, every 2 months for the first 12 months, and every 6 months during the 2nd and 3rd years of follow-up. The surveys will collect information about the participants' general health and well-being while taking these medications.
Clinical follow-up will occur in the context of routine care (e.g., clinic visits, telehealth encounters) for a minimum of 1-year and up to 3 years after the index date, regardless of whether the participant remains on the index treatment. The study anticipates relatively standard follow-up for each participant, based on best clinical practice, while allowing for natural variation.
The study will collect data abstracted from the medical charts of enrolled participants. Baseline data, including potential confounders described in the statistical analysis plan, will be collected by sites upon participant enrollment or shortly thereafter. Follow-up data will be collected with each outpatient gastrointestinal (GI) visit, hospitalization, surgery, colonoscopy, imaging test (MRI, CT, intestinal ultrasound), laboratory test (unless electronically captured), IBD medication change, and adverse events.
In addition, structured electronic health record (EHR) data on enrolled participants will be extracted using automated queries utilizing the PCORnet® PCORnet Common Data Model (CDM) to supplement case report forms. EHR data extraction will include laboratory values, anthropometrics, emergency department (ED) visits (and diagnosis codes), hospitalizations (and diagnosis codes), antibiotic/antiviral prescriptions, encounter dates, and diagnosis codes for events of special interest (e.g., infections, malignancy, blood clots).
The study will collect and record adverse events from participants and their caregivers, as well as via regular EHR queries using the PCORnet® CDM.
Prospective enrollment is expected to take approximately 36 months with a minimum follow-up of 12 months for each participant (maximum of 36 months).
- Keywords
- Ulcerative colitis, pediatric, Inflammatory bowel disease, pediatric, IBD, CD, UC, PIBD, Pediatrics, Children, Anti-TNF, Vedolizumab, Ustekinumab, Risankizumab, Guselkumab, Mirikizumab, Tofacitinib, Upadacitinib, Patient-reported outcomes (PROs), Tumor necrosis factor antagonists, IL-23 agent, PCORI
- Medical subject headings
- Pediatric ulcerative colitis, Inflammatory Bowel Diseases, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children with Crohn's disease (CD) | Pediatric CD patients initiating non-anti-TNF biologics and small molecules that are FDA-approved for adult populations | |
| Children with Ulcerative Colitis (UC) | Pediatric UC patients initiating non-anti-TNF biologics and small molecules that are FDA-approved for adult populations | |
| Retrospective Safety Analysis | Retrospective cohort focused on the long-term safety of non-anti-TNF biologics and small molecules that are FDA-approved for adult populations in for CD and or UC. Electronic health record (EHR) data (retrospective cohort) will be collected from medical charts and EHRs at participating institutions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of Crohn's disease (CD) impact on patients' daily lives (TUMMY CD)
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.
Measured: Baseline, months 2, 4, 6, 8, 10, 12, 18, 24, 30, 36
Measures of ulcerative colitis (UC) impact on patients' daily lives (TUMMY UC)
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.
Measured: Baseline, months 2, 4, 6, 8, 10, 12, 18, 24, 30, 36
PROMIS Symptom Measure of Irritable Bowel Disease (IBD)
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
Measured: 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)
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.
Measured: Baseline, months 6, 12, 18, 24, 30, 36
Change in Pediatric PROMIS® Fatigue Score for Crohn's Disease and Ulcerative Colitis (CD and UC)
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.
Measured: Baseline, months 6, 12, 18, 24, 30, 36
Change in Pediatric PROMIS® Anxiety Score for Crohn's Disease and Ulcerative Colitis (CD and UC)
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.
Measured: Baseline, months 6, 12, 18, 24, 30, 36
Change in Pediatric PROMIS® Depression Score for Crohn's Disease and Ulcerative Colitis (CD and UC)
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.
Measured: Baseline, months 6, 12, 18, 24, 30, 36
Change in sPCDAI Score for Crohn's Disease
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
Measured: Each clinic visit (baseline through follow-up, up to 3 years)
Change in Pediatric Ulcerative Colitis Activity Index (PUCAI) Score
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.
Measured: Each clinic visit (baseline through follow-up, up to 3 years)
Secondary outcomes (4)
Change in Fecal Calprotectin Concentration (CD and UC)
Fecal calprotectin is a noninvasive biomarker of intestinal inflammation. Stool samples will be collected at baseline and follow-up visits. Calprotectin concentration will be measured in micrograms per gram (µg/g) of stool. The outcome will be measured as the mean change in fecal calprotectin from baseline to follow-up. Higher values indicate greater intestinal inflammation. A threshold of < 150 μg/g will be used to define remission.
Measured: 12 months after after taking prescribed medication for CD or UC
Number of Participants Experiencing Adverse Events (CD and UC)
Safety will be assessed by collecting and monitoring all adverse events (AEs) and serious adverse events (SAEs). Adverse events will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), where applicable. The outcome will be summarized as the number of participants experiencing AE/SAE of grade 2 or higher.
Measured: After medication administration and every 3 months, up to 3 years
Proportion of Participants Experiencing Adverse Events (CD and UC)
Safety will be assessed by collecting and monitoring all adverse events (AEs) and serious adverse events (SAEs). Adverse events will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), where applicable. The outcome will be summarized as the proportion of participants experiencing AE/SAE of grade 2 or higher.
Measured: After medication administration and every 3 months, up to 3 years
Exploration of Heterogeneity of Treatment Effects (HTE) Across Clinical Subgroups (CD and UC)
Heterogeneity of treatment effects (HTE) will be evaluated per baseline phenotype query that will run against the electronic health record (EHR) at sites. Treatment effects will be estimated within each subgroup (CD and UC) and compared to assess differential response patterns. This analysis is intended to identify variability in treatment response.
Measured: Baseline through follow -up for up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start1 Nov 2025
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis, PediatricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Duke Clinical Research Institute
- Responsible party
- Sponsor
- Investigators
- Michael D Kappelman, MD, Principal investigator, Universty of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198113
- Sponsor's protocol ID
- 25-2019
- Other IDs
- Pro00118431
- Acronym
- COMPARE
- Status last verified
- Apr 2026
- First submitted
- 19 Sep 2025
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Medications Post Anti-TNF: Researching Effectiveness in Pediatric IBD
- ClinicalTrials.gov ID
- NCT07198113
- Acronym / sponsor ID
- COMPARE / 25-2019
- Keywords
- Ulcerative colitis, pediatric, Inflammatory bowel disease, pediatric, IBD, CD, UC, PIBD, Pediatrics, Children
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Duke Clinical Research Institute
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
COMPARE is a multi-center, observational cohort study that includes both prospective and retrospective components and two patient population cohorts-Crohn's disease (CD) and ulcerative colitis (UC). The study will recruit pediatric IBD patients initiating non-anti-TNF biologics and small molecules that are FDA-approved for adult populations. The primary analyses in each cohort will compare the two most frequently used classes, with all IL-23 agents analyzed as a single class. Secondary comparisons will be conducted for any classes initiated by at least 50 participants. The investigators will also perform a retrospective cohort study using EHR data extracted from participating sites.
IL-23 agents could be any of the following medications:
- Vedolizumab (trade name Entyvio™)
- Ustekinumab (trade name Stelara™)
- Risankizumab (trade name Skyrizi™)
- Guselkumab (trade name Tremfya™)
- Mirikizumab (trade name Omvoh™)
- Tofacitinib (trade name Xeljanz™)
- Upadacitinib (trade name Rinvoq™)
While taking these medications, participants (or parent/caregiver proxies) will complete patient-reported outcome surveys (PROS) at baseline, every 2 months for the first 12 months, and every 6 months during the 2nd and 3rd years of follow-up. The surveys will collect information about the participants' general health and well-being while taking these medications.
Clinical follow-up will occur in the context of routine care (e.g., clinic visits, telehealth encounters) for a minimum of 1-year and up to 3 years after the index date, regardless of whether the participant remains on the index treatment. The study anticipates relatively standard follow-up for each participant, based on best clinical practice, while allowing for natural variation.
The study will collect data abstracted from the medical charts of enrolled participants. Baseline data, including potential confounders described in the statistical analysis plan, will be collected by sites upon participant enrollment or shortly thereafter. Follow-up data will be collected with each outpatient gastrointestinal (GI) visit, hospitalization, surgery, colonoscopy, imaging test (MRI, CT, intestinal ultrasound), laboratory test (unless electronically captured), IBD medication change, and adverse events.
In addition, structured electronic health record (EHR) data on enrolled participants will be extracted using automated queries utilizing the PCORnet® PCORnet Common Data Model (CDM) to supplement case report forms. EHR data extraction will include laboratory values, anthropometrics, emergency department (ED) visits (and diagnosis codes), hospitalizations (and diagnosis codes), antibiotic/antiviral prescriptions, encounter dates, and diagnosis codes for events of special interest (e.g., infections, malignancy, blood clots).
The study will collect and record adverse events from participants and their caregivers, as well as via regular EHR queries using the PCORnet® CDM.
Prospective enrollment is expected to take approximately 36 months with a minimum follow-up of 12 months for each participant (maximum of 36 months).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Children with Crohn's disease (CD) | – | –Pediatric CD patients initiating non-anti-TNF biologics and small molecules that are FDA-approved for adult populations |
| Children with Ulcerative Colitis (UC) | – | –Pediatric UC patients initiating non-anti-TNF biologics and small molecules that are FDA-approved for adult populations |
| Retrospective Safety Analysis | – | –Retrospective cohort focused on the long-term safety of non-anti-TNF biologics and small molecules that are FDA-approved for adult populations in for CD and or UC. Electronic health record (EHR) data (retrospective cohort) will be collected from medical charts and EHRs at participating institutions. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with Crohn's disease (CD) or ulcerative colitis (UC) whose disease is refractory to anti-TNF therapy
Key inclusion criteria (5 listed)
- 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 antibody), ustekinumab (anti-IL-12/23 antibody), risankizumab, guselkumab, or mirikizumab, (IL-23 inhibitors), tofacitinib (JAK inhibitor), and upadacitinib (JAK inhibitor). Biosimilars or generic medications for any of the above will also be allowed and handled/analyzed in an identical manner to originators.
- Ability to provide child assent, if required per regulatory or local institutional guidelines, and parental informed consent in English or Spanish
Key exclusion criteria (5 listed)
- Plans to change care to a different center within 1 year
- Prior use of a comparator agent (i.e., only patients starting their first comparator medication as monotherapy following anti-TNF will be eligible)
- Contraindication to any of the treatments under investigation
- Patients with UC or IBD-U who have undergone colectomy
- Patients with current ostomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure of Crohn's disease (CD) impact on patients' daily lives (TUMMY CD)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 Disease
Time frame: Each 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) Score
Time frame: Each 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.
4 secondary outcomes
Change in Fecal Calprotectin Concentration (CD and UC)
Time frame: 12 months after after taking prescribed medication for CD or UC
Number of Participants Experiencing Adverse Events (CD and UC)
Time frame: After medication administration and every 3 months, up to 3 years
Proportion of Participants Experiencing Adverse Events (CD and UC)
Time frame: After medication administration and every 3 months, up to 3 years
Exploration of Heterogeneity of Treatment Effects (HTE) Across Clinical Subgroups (CD and UC)
Time frame: Baseline through follow -up for up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael D Kappelman, MD principal investigator
Universty of North Carolina, Chapel Hill
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, Pediatric and Inflammatory Bowel Diseases, run by University of North Carolina, Chapel Hill at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Duke Clinical Research Institute COMPARE Call Center (833-850-2848, COMPARE@dm.duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of Crohn's disease (CD) impact on patients' daily lives (TUMMY CD) (time frame: Baseline, months 2, 4, 6, 8, 10, 12, 18, 24, 30, 36). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.