[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600813":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":16,"locations":22,"responsibleParty":36,"collaborators":10,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":40,"sex":46,"minAge":47,"maxAge":10,"enrollmentInfo":48,"targetDuration":10,"studyType":51,"phases":10,"briefSummary":52,"conditions":53,"keywords":57,"overallStatus":25,"whyStopped":10,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Janssen-Cilag G.m.b.H","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Group 1: Moderate-to-Severe Ulcerative Colitis (UC) or Crohn's Disease (CD)",null,"Participants with confirmed diagnosis of moderate-to-severe UC or CD treated with guselkumab as per standard clinical practice will be enrolled. Only data available from clinical routine will be collected in this study. During the observational period, data will be collected at weeks 0 (baseline), 4, 8, 12, 24, 48, 72, and 96, where available as per clinical routine. The respective collection times relate to the first study dose of guselkumab.",[13],{"name":14,"affiliation":5,"role":15},"Janssen-Cilag G.m.b.H, Germany Clinical Trial","STUDY_DIRECTOR",[17],{"name":18,"role":19,"phone":20,"phoneExt":10,"email":21},"Study Contact","CONTACT","844-434-4210","Participate-In-This-Study1@its.jnj.com",[23],{"facility":24,"status":25,"city":26,"state":10,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":10},"Praxis Fur Gastroenteroligie","RECRUITING","Berlin","10825","Germany","DE",{"type":31,"coordinates":32},"Point",[33,34],13.41053,52.52437,{"lat":34,"lon":33},{"type":37,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100600813","a-study-to-generate-real-world-evidence-of-guselkumab-effectiveness-in-inflammatory-bowel-disease-in-germany-100600813",false,"NCT07102368","A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany","Generation of Real-world Evidence of Guselkumab in IBD Evaluating Effectiveness, Early Outcomes and Patient Relevant Aspects","GORGEOUS","Inclusion Criteria:\n\n1. Must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics\n2. Signed informed consent form is available, allowing data collection and source data verification in accordance with local requirements\n3. By judgement of the treating physician, the participant is able and willing to complete the patient-reported outcome(s) (PROs) assessments for the duration of the study\n\nExclusion Criteria:\n\n1. Has a history of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy\n2. Has been previously exposed to interleukin (IL)-23 inhibitors. As an exception, participants with history of ustekinumab exposure may be included\n3. Has had a colectomy and\u002For a pouch\n4. Is currently enrolled in an interventional clinical study or another non-interventional study from Janssen or Johnson \\& Johnson (J\\&J)","ALL","18 Years",{"count":49,"type":50},500,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to characterize participants with Crohn's Disease (CD) and Ulcerative Colitis (UC) treated with Guselkumab in a real-world setting, and to assess the clinical effectiveness (how well the treatment works) in the overall population and in different participant subgroups. Furthermore patient-reported outcomes like fatigue, health-related quality of life (HRQoL), sexuality, work productivity and activity as well as treatment satisfaction will be assessed.",[54,55,56],"Inflammatory Bowel Disease","Colitis, Ulcerative","Crohn's Disease",[58,59,56,60,61,62,63,64,65,66,55,67,68,69,70],"IBD","Ulcerative Colitis","Gastroenteritis","Gastrointestinal Diseases","Digestive System Diseases","Colonic Diseases","Intestinal Diseases","Pathologic Processes","Inflammatory Bowel Diseases","Ulcer","Guselkumab","Tremfya","Inflammatory","2026-06-04",{"date":73,"type":74},"2026-06-05","ACTUAL",{"date":76,"type":74},"2025-08-18",{"date":78,"type":50},"2029-01-15",{"name":5,"class":6},1]