[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ibd-unclassified-ibd-u\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ibd-unclassified-ibd-u":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100611808","switching-to-the-il-23-inhibitor-guselkumab-for-people-with-active-ibd-who-previously-used-ustekinumab-shift-ibd-100611808",false,"NCT07245394","Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)","SHIFT-IBD: Switching to High-efficacy Anti-IL-23 Guselkumab in Ustekinumab-exposed Persons With Active IBD","SHIFT-IBD","Inclusion Criteria:\n\n* Subjects of any gender aged ≥ 18.\n* Confirmed diagnosis of IBD (CD, UC, or IBDU) for at least 6 months prior to baseline visit. Subjects with IBDU will be grouped with subjects with UC. The CD proportion of patients will be capped at 75%.\n* Subjects have received ustekinumab for at least 14 weeks and who are currently on or recently discontinued ustekinumab therapy.\n* For subjects that have recently discontinued ustekinumab, the last dose of ustekinumab must have been within 12 weeks before Week 0, and no other advanced therapy (i.e., infliximab, adalimumab, golimumab, certolizumab pegol, vedolizumab, natalizumab, risankizumab, mirikizumab, tofacitinib, upadacitinib, ozanimod, etrasimod) was started since stopping ustekinumab.\n* Subjects with an inadequate response to ustekinumab who require a change in advanced therapy and are initiating guselkumab, as determined by the treating physician.\n* For subjects on off-label ustekinumab dosing (90 mg every 4 or 6 weeks (off-label dosing), enrollment will be capped at 60%.\n* Ability and willingness to give written informed consent and comply with the requirements of this study protocol.\n* Subjects who have evidence of ongoing endoscopic evidence of disease activity within 3 months prior to Week 0, defined as:\n\n  * For Crohn's Disease: Colonoscopy showing SES-CD score (excluding the presence of narrowing component) of ≥6 (or ≥4 for participants with isolated ileal disease), OR presence of ulcers larger than 5 mm in any segment.\n  * For Ulcerative Colitis: Colonoscopy showing Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score ≥4, OR presence of erosions or ulcers in any segment.\n\nExclusion Criteria:\n\n* History of prior exposure to any anti-p19 inhibitor (risankizumab or mirikizumab).\n* Subjects with formal contraindication to guselkumab per the drug label.\n* Use of guselkumab for an off-label indication, dosing regimen, or route of administration. Subjects who did not receive guselkumab induction will be excluded.\n* Subjects with an ostomy or ileo-anal pouch.\n* Subjects with a history of bowel surgery within 6 months prior to Week 0.\n* Subjects displaying clinical signs of acute severe UC, fulminant colitis or toxic megacolon within 3 months prior to Week 0.\n* Subjects who are expected to require bowel surgery by their IBD physician within the year of enrollment.\n* Subjects on 1 or more concomitant biologics.\n* Subjects with a history of colonic dysplasia (low-grade dysplasia, high-grade dysplasia, or colorectal cancer). Note: Patients with a history of indefinite for dysplasia would be eligible.\n* Subjects with formal contraindication or unwilling to undergo lower endoscopy.\n* The patient is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.","ALL","18 Years",{"count":20,"type":21},200,"ESTIMATED","OBSERVATIONAL","The SHIFT-IBD Study is being conducted at multiple medical centers across Canada to evaluate how well guselkumab (Tremfya) works for people with inflammatory bowel disease (IBD) who haven't responded well enough to ustekinumab.\n\nPatients will begin guselkumab based on their doctor's decision. If eligible, they may be invited to participate in the study, which involves monitoring symptoms, test results, and overall health over the course of one year.\n\nGuselkumab will be given according to local medical guidelines. Doctors can adjust the treatment as needed, just like in routine care.\n\nResearchers believe that switching to guselkumab may be as effective as other advanced treatments. For those who saw some improvement on ustekinumab but not enough, guselkumab may offer better symptom control-without worsening results on medical tests like endoscopy.\n\nThe goal is to explore better treatment options for people whose IBD has not been well controlled with current therapies.",[25,26,27,28],"Inflammatory Bowel Disease (IBD)","Crohn Disease (CD)","Ulcerative Colitis (UC)","IBD-unclassified (IBD-U)","RECRUITING","2026-02-10",{"date":32,"type":33},"2026-02-12","ACTUAL",{"date":35,"type":33},"2026-01-29",{"date":37,"type":21},"2028-11-01",{"name":39,"class":40},"TIDHI Innovation Inc.","OTHER",9,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":18,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100589430","therapeutic-drug-monitoring-for-biological-therapy-in-pediatric-inflammatory-bowel-disease-100589430","NCT06954311","Therapeutic Drug Monitoring for Biological Therapy in Pediatric Inflammatory Bowel Disease","Therapeutic Drug Monitoring for Biological Therapy in Pediatric Inflammatory Bowel Disease: a Prospective Non-interventional Multicentric Study","TDMpIBD","Inclusion Criteria:\n\n* Pediatric patients with an Inflammatory Bowel Disease (Crohn's disease, ulcerative colitis, and IBD-unclassified) being under 18 years of age\n* Treatment with Infliximab, Adalimumab, Vedolizumab, or Ustekinumab during induction or maintenance phase\n\nExclusion Criteria:\n\n\\-- Patients with primary (congenital) immunodeficiency","0 Years",{"count":52,"type":21},120,"Inflammatory Bowel Diseases (IBD), which include Crohn's disease (CD), ulcerative colitis (UC), and the unclassified form referred to as indeterminate colitis, are most commonly diagnosed during adolescence and early adulthood. In recent decades, an increasing incidence of IBD has been observed in this age group.\n\nA wide range of immunomodulatory agents, from corticosteroids to monoclonal antibodies, are now available for the treatment of IBD. These antibodies, known as biologics, target, for example, tumor necrosis factor-alpha (TNF-α; e.g., infliximab and adalimumab), integrin α4β7 (vedolizumab), or interleukin-12\u002F23 (ustekinumab). While infliximab and adalimumab are approved for pediatric use in CD and UC, vedolizumab is only approved for moderate-to-severe UC from the age of 16, and ustekinumab is not approved for pediatric use at all. Nevertheless, vedolizumab and ustekinumab are frequently used off-label in cases of treatment failure with approved therapies, as efficacy has been demonstrated in adult IBD patients, and since 2015, increasing pediatric literature has emerged on their use.\n\nTo facilitate appropriate dose adjustment in pediatric clinical practice, biologic therapies can be monitored through measurement of drug trough levels. Current pediatric guidelines already recommend incorporating therapeutic drug monitoring (TDM) of infliximab and adalimumab in the management of CD and UC. Studies on TDM for vedolizumab and ustekinumab have so far been conducted almost exclusively in adult IBD patients, where improved treatment responses have also been demonstrated.\n\nThe presented research is a prospective, non-interventional observational study involving pediatric IBD patients at multiple Austrian pediatric gastroenterology centers. The study duration is five years. The aim is to include at least 40 patients receiving induction and maintenance therapy with infliximab or adalimumab, and 20 patients treated with vedolizumab or ustekinumab during both treatment phases. The primary objective is to gain a better understanding of the pharmacokinetic dynamics of these biologics and the associated treatment response in pediatric settings. Data will be collected exclusively from routine clinical assessments. No additional study-related visits or interventions are planned.",[27,28],[56,57,58,59,60,61,62],"IBD","Pediatric","Biologicals","Infliximab","Adalimumab","Vedolizumab","Ustekinumab","2025-04-24",{"date":65,"type":33},"2025-05-01",{"date":67,"type":33},"2025-02-17",{"date":69,"type":21},"2030-02-17",{"name":71,"class":40},"Medical University Innsbruck",10,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":83,"targetDuration":85,"studyType":22,"phases":4,"briefSummary":86,"conditions":87,"keywords":98,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100566456","family-members-at-increased-risk-for-developing-inflammatory-bowel-disease-100566456","NCT06655415","Family Members At INcreased-risk for Developing Inflammatory Bowel Disease","Family Members At INcreased-risk for Developing Inflammatory Bowel Disease (FIND-IBD)","FIND-IBD","Inclusion Criteria:\n\n* Ability to give informed consent\n* Ability to complete all study visits and study-related procedures\n* Ability to understand and complete study questionnaires\n* Must have at least one first-degree relative with inflammatory bowel disease (Crohn's disease, ulcerative colitis, or IBD-unclassified)\n* Age ≥ 14\n\nExclusion Criteria:\n\n* Individuals with existing diagnoses of inflammatory bowel disease (ulcerative colitis, Crohn's disease, or IBD-unclassified)\n* Evidence of clinical signs or symptoms of IBD, which will be identified on pre-screening interview with the study coordinator.",true,"14 Years",{"count":84,"type":21},50,"10 Years","First-degree relatives of people with inflammatory bowel disease (\"IBD,\" including Crohn's disease and ulcerative colitis) have an increased risk for developing IBD themselves. This study will follow unaffected first-degree relatives (who do not have IBD) over time to understand if their behaviors, diet, and biomarkers for IBD can help predict who gets IBD and if IBD can be prevented in these high-risk individuals. Participants will be asked once per year to complete a questionnaire and have their blood, stool, and urine collected. The anticipated length of the study (registry) is approximately 10 years or longer. Parts of this study, such as the questionnaires and stool and urine collection, may be done from home, while other parts, such as the blood draw, will need to be done from Massachusetts General Hospital.",[25,27,28,88,89,90,91,92,93,94,95,96,97],"Indeterminate Colitis","Crohn's Disease Colon","Crohn's Colitis","Crohn's Ileocolitis","Crohn's Gastritis","Crohn's Jejunitis","Crohn's Duodenitis","Crohn's Esophagitis","Ulcerative Proctitis","Ulcerative Proctosigmoiditis",[99,56,100,101],"Inflammatory Bowel Disease","Ulcerative colitis","Crohn's disease","2024-12-18",{"date":104,"type":33},"2024-12-20",{"date":102,"type":33},{"date":107,"type":21},"2034-12",{"name":109,"class":40},"Massachusetts General Hospital",1]