[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552156":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":21,"centralContacts":25,"locations":33,"responsibleParty":111,"collaborators":113,"id":117,"slug":118,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":119,"sex":124,"minAge":125,"maxAge":10,"enrollmentInfo":126,"targetDuration":129,"studyType":130,"phases":10,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa","OTHER",[8,12,15,18],{"label":9,"type":10,"description":11,"interventionNames":10},"Cohort 1 (Tofacitinib cohort):",null,"Initiation of tofacitinib (i.e., first ever prescription) from 01 July 2018 through to 31 March 2025",{"label":13,"type":10,"description":14,"interventionNames":10},"Cohort 2 (Biologics cohort):","* Initiation (i.e., first ever prescription) of a specific biologic agent (any TNFi or non-TNFi agent) from 01 July 2018 through to 31 March 2025\n* No prior use of specific biologic agent prior to index date using all available data",{"label":16,"type":10,"description":17,"interventionNames":10},"Cohort 3 (Immunosuppressants cohort):","* Initiation (i.e., first ever prescription) of a specific immunosuppressant agent (without concurrent biologic therapy) from 01 July 2018 through to 31 March 2025\n* No prior use of specific immunosuppressant prior to index date using all available data",{"label":19,"type":10,"description":20,"interventionNames":10},"Cohort 4 (Naïve cohort):","* Patients diagnosed with UC since 01 July 2018 through to 31 March 2025\n* Patients with no history of surgery for UC (surgery suggests more severe disease, and such patients would not be representative of patients with generally mild disease in Cohort 4)",[22],{"name":23,"affiliation":5,"role":24},"Manuel MD Barreiro, PhD","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Eva María Rodríguez","CONTACT","+34 691 08 42 07","secretariacientifica1@geteccu.org",{"name":23,"role":28,"phone":10,"phoneExt":10,"email":32},"manubarreiro@hotmail.com",[34,51,64,79,95],{"facility":35,"status":36,"city":37,"state":10,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Imelda General Hospital","RECRUITING","Bonheiden","28202","Belgium","BE",{"type":42,"coordinates":43},"Point",[44,45],4.54714,51.02261,{"lat":45,"lon":44},[48],{"name":49,"role":28,"phone":10,"phoneExt":10,"email":50},"Peter BOSSUYT, MD","peter.bossuyt@imelda.be",{"facility":52,"status":36,"city":53,"state":10,"zip":54,"country":39,"countryCode":40,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"AZ Delta vzw","Roeselare","8800",{"type":42,"coordinates":56},[57,58],3.12269,50.94653,{"lat":58,"lon":57},[61],{"name":62,"role":28,"phone":10,"phoneExt":10,"email":63},"Filip BAERT, MD","filip.baert@azdelta.be",{"facility":65,"status":36,"city":66,"state":10,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Acibadem City Clinic Tokuda University Hospital","Sofia","1407","Bulgaria","BG",{"type":42,"coordinates":71},[72,73],23.32415,42.69751,{"lat":73,"lon":72},[76],{"name":77,"role":28,"phone":10,"phoneExt":10,"email":78},"Anelia DECHEVA, MD","andecheva@gmail.com",{"facility":80,"status":36,"city":81,"state":82,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"General Hospital of Athens \"Evangelismos\"","Ellinikó","Attica","16777","Greece","GR",{"type":42,"coordinates":87},[88,89],23.74406,37.89013,{"lat":89,"lon":88},[92],{"name":93,"role":28,"phone":10,"phoneExt":10,"email":94},"Nikolaos VIAZIS, MD","nikos.viazis@gmail.com",{"facility":96,"status":97,"city":98,"state":10,"zip":99,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Lithuanian University of Life Sciences","NOT_YET_RECRUITING","Kaunas","44307","Lithuania","LT",{"type":42,"coordinates":103},[104,105],23.90909,54.90156,{"lat":105,"lon":104},[108],{"name":109,"role":28,"phone":10,"phoneExt":10,"email":110},"Gediminas KIUDELIS, MD","gediminas.kiudelis@kaunoklinikos.lt",{"type":112,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[114],{"name":115,"class":116},"Pfizer","INDUSTRY","100552156","an-active-surveillance-post-authorization-study-to-characterize-the-safety-of-tofacitinib-in-patients-with-moderately-to-severely-active-ulcerative-colitis-in-the-real-world-setting-using-data-from-the-united-registries-for-clinical-assessment-and-research-ur-care-in-the-european-union-eu-100552156",false,"NCT06469424","An Active Surveillance, Post-Authorization Study to Characterize the Safety of Tofacitinib in Patients With Moderately to Severely Active Ulcerative Colitis in the Real-World Setting Using Data From the United Registries for Clinical Assessment and Research (UR-CARE) in the European Union (EU)","PASS TOFA","Inclusion Criteria:\n\n* Adult patients aged ≥18 years,\n* With Ulcerative colitis diagnosis per ECCO guidelines,\n* Enrolled in UR-CARE registry with 12 months of medical history available in UR-CARE prior to the index date,\n* With an informed consent signed. A minimum follow-up duration of 12 months will allow evaluation of safety events of interest.\n\nExclusion Criteria:\n\n* Patients not meeting the inclusion criteria\n* Patients who have any records of Crohn's Diseases (CD) or IBD unspecified in UR-CARE between the last UC diagnosis and index date \\[i.e. date of first prescription for tofacitinib\\].","ALL","18 Years",{"count":127,"type":128},104,"ESTIMATED","12 Months","OBSERVATIONAL","The purpose of this study is to estimate the incidence rates of malignancy, excluding non-melanoma skin cancer (NMSC), venous thromboembolic events VTE (deep venous thrombosis \\[DVT\\] and pulmonary embolism \\[PE\\]), NMSC, major adverse cardiac events (MACE), progressive multifocal leukoencephalopathy (PML), infections, hospitalization and specific antibiotic or antiviral treatment, lung cancer, lymphoma, herpes zoster, myocardial infarction (MI), gastrointestinal (GI) perforations, fractures, surgery for UC and death; through 4 sub-groups: adult patients with UC who initiate tofacitinib in the course of routine clinical care compared to other medications approved to treat UC.",[133],"Ulcerative Colitis",[135],"prospective observational study with medication","2024-06-17",{"date":138,"type":139},"2024-06-21","ACTUAL",{"date":141,"type":139},"2024-01-11",{"date":143,"type":128},"2026-03-31",{"name":5,"class":6},5]