Clinical Outcomes of Medications Post Anti-TNF: Researching Effectiveness in Pediatric IBD
University of North Carolina, Chapel Hill
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). 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.
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 a…
Eligibility
- Age range
- 1–18 years
- Sex
- All
- Healthy volunteers
- No
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 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 or…
Locations (4)
- University of North Carolina at Chapel HillChapel Hill, North Carolina
- Atrium HealthCharlotte, North Carolina
- Duke Health SystemDurham, North Carolina
- University of Pittsburgh Medical Center, Children's HospitalPittsburgh, Pennsylvania