Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
1100 participants
OBSERVATIONAL
2025-11-01
2028-09-30
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Children with Crohn's disease (CD)
Pediatric CD patients initiating non-anti-TNF biologics and small molecules that are FDA-approved for adult populations
No interventions assigned to this group
Children with Ulcerative Colitis (UC)
Pediatric UC patients initiating non-anti-TNF biologics and small molecules that are FDA-approved for adult populations
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
1 Year
18 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Duke Clinical Research Institute
OTHER
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Michael D Kappelman, MD
Role: PRINCIPAL_INVESTIGATOR
Universty of North Carolina, Chapel Hill
Locations
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke Health System
Durham, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Pro00118431
Identifier Type: OTHER
Identifier Source: secondary_id
25-2019
Identifier Type: -
Identifier Source: org_study_id
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