[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608173":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":18,"centralContacts":23,"locations":29,"responsibleParty":91,"collaborators":93,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":100,"sex":106,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":10,"studyType":112,"phases":10,"briefSummary":113,"conditions":114,"keywords":118,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"University of North Carolina, Chapel Hill","OTHER",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"Children with Crohn's disease (CD)",null,"Pediatric CD patients initiating non-anti-TNF biologics and small molecules that are FDA-approved for adult populations",{"label":13,"type":10,"description":14,"interventionNames":10},"Children with Ulcerative Colitis (UC)","Pediatric UC patients initiating non-anti-TNF biologics and small molecules that are FDA-approved for adult populations",{"label":16,"type":10,"description":17,"interventionNames":10},"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.",[19],{"name":20,"affiliation":21,"role":22},"Michael D Kappelman, MD","Universty of North Carolina, Chapel Hill","PRINCIPAL_INVESTIGATOR",[24],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},"Duke Clinical Research Institute COMPARE Call Center","CONTACT","833-850-2848","COMPARE@dm.duke.edu",[30,49,63,77],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"University of North Carolina at Chapel Hill","RECRUITING","Chapel Hill","North Carolina","27599","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-79.05584,35.9132,{"lat":42,"lon":41},[45],{"name":46,"role":26,"phone":47,"phoneExt":10,"email":48},"Ajay Gulati, MD","919-962-9900","ajay_gulati@med.unc.edu",{"facility":50,"status":32,"city":51,"state":34,"zip":52,"country":36,"countryCode":37,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"Atrium Health","Charlotte","28203",{"type":39,"coordinates":54},[55,56],-80.84313,35.22709,{"lat":56,"lon":55},[59],{"name":60,"role":26,"phone":61,"phoneExt":10,"email":62},"Tiffany Linville, MD","704-381-8800","pediatricresearch@atriumhealth.org",{"facility":64,"status":32,"city":65,"state":34,"zip":66,"country":36,"countryCode":37,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Duke Health System","Durham","27701",{"type":39,"coordinates":68},[69,70],-78.89862,35.99403,{"lat":70,"lon":69},[73],{"name":74,"role":26,"phone":75,"phoneExt":10,"email":76},"Annette Babu","919-681-8739","annette.babu@duke.edu",{"facility":78,"status":32,"city":79,"state":80,"zip":81,"country":36,"countryCode":37,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"University of Pittsburgh Medical Center, Children's Hospital","Pittsburgh","Pennsylvania","15222",{"type":39,"coordinates":83},[84,85],-79.99589,40.44062,{"lat":85,"lon":84},[88],{"name":89,"role":26,"phone":90,"phoneExt":10,"email":10},"Whitney Sunseri, MD","412-692-5180",{"type":92,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[94,96],{"name":95,"class":6},"Patient-Centered Outcomes Research Institute",{"name":97,"class":6},"Duke Clinical Research Institute","100608173","compare---pediatric-inflammatory-bowel-disease-pibd-100608173",false,"NCT07198113","COMPARE - Pediatric Inflammatory Bowel Disease (PIBD)","Clinical Outcomes of Medications Post Anti-TNF: Researching Effectiveness in Pediatric IBD","COMPARE","Inclusion Criteria:\n\n* Age \\\u003C 18 years at study enrollment\n* Diagnosis of CD, UC, or IBD-U by standard diagnostic criteria\n* Prior non-response or loss of response to one or more anti-TNF agents\n* Planning to initiate treatment with any of the following comparator agents: vedolizumab (α4β7 integrin antibody), ustekinumab (anti-IL-12\u002F23 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\u002Fanalyzed in an identical manner to originators.\n* Ability to provide child assent, if required per regulatory or local institutional guidelines, and parental informed consent in English or Spanish\n\nExclusion Criteria:\n\n* Plans to change care to a different center within 1 year\n* Prior use of a comparator agent (i.e., only patients starting their first comparator medication as monotherapy following anti-TNF will be eligible)\n* Contraindication to any of the treatments under investigation\n* Patients with UC or IBD-U who have undergone colectomy\n* Patients with current ostomy","ALL","1 Year","18 Years",{"count":110,"type":111},1100,"ESTIMATED","OBSERVATIONAL","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:\n\nAre the newer medications used to treat IBD just as safe and effective for treating IBD in children.\n\nParticipants 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.",[115,116,117],"Ulcerative Colitis, Pediatric","Inflammatory Bowel Diseases","Crohn Disease",[119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,104],"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","PCORnet","DCRI","Duke","UNC","University of North Carolina","Observational cohort","Anti-tumor necrosis factor (TNF) refractory","Comparative Effectiveness Research (CER)","2026-04-13",{"date":149,"type":150},"2026-04-17","ACTUAL",{"date":152,"type":150},"2025-11-01",{"date":154,"type":111},"2028-09",{"name":5,"class":6},4]