[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552156":3},{"organization":4,"outcomesModule":7,"designInfo":55,"detailedDescription":58,"studyPopulation":59,"armGroups":60,"interventions":54,"overallOfficials":73,"centralContacts":77,"locations":85,"responsibleParty":163,"collaborators":165,"id":169,"slug":54,"hasResults":170,"nctId":171,"briefTitle":172,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":170,"sex":175,"minAge":176,"maxAge":54,"enrollmentInfo":177,"targetDuration":180,"studyType":181,"phases":54,"briefSummary":182,"conditions":183,"keywords":185,"overallStatus":88,"whyStopped":54,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":196},{"fullName":5,"class":6},"Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":54},[9,13],{"measure":10,"description":11,"timeFrame":12},"Malignancy excluding non-melanoma skin cancer (NMSC)","Malignancy excluding non-melanoma skin cancer (NMSC). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.","from 01 July 2018 through to 31 March 2025",{"measure":14,"description":15,"timeFrame":12},"venous thromboembolic events (VTE),(deep venous thrombosis [DVT] and pulmonary embolism [PE])","deep venous thrombosis \\[DVT\\] and pulmonary embolism \\[PE\\]. As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.",[17,20,23,26,29,32,35,37,40,43,46,49,51],{"measure":18,"description":19,"timeFrame":12},"Non melanoma skin cancer (NMSC)","Non melanoma skin cancer (NMSC). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.",{"measure":21,"description":22,"timeFrame":12},"Lung cancer","Lung cancer. As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.",{"measure":24,"description":25,"timeFrame":12},"Lymphoma","Lymphoma (including 3 main subtypes Hodgkin's lymphoma, non-Hodgkin's lymphoma, and chronic lymphocytic lymphoma).\n\nAs this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.",{"measure":27,"description":28,"timeFrame":12},"Serious infections","Serious infections. As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.",{"measure":30,"description":31,"timeFrame":12},"Opportunistic infections (e.g., tuberculosis)","Opportunistic infections (e.g., tuberculosis). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.",{"measure":33,"description":34,"timeFrame":12},"Herpes zoster(HZ)","Herpes zoster(HZ). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.",{"measure":36,"description":36,"timeFrame":12},"Major adverse cardiac events (MACE)",{"measure":38,"description":39,"timeFrame":12},"Myocardial infarction (MI)","Myocardial infarction (MI). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.",{"measure":41,"description":42,"timeFrame":12},"Progressive multifocal leukoencephalopathy (PML)","Progressive multifocal leukoencephalopathy (PML). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.",{"measure":44,"description":45,"timeFrame":12},"Gastrointestinal (GI) perforations","Gastrointestinal (GI) perforations. As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.",{"measure":47,"description":48,"timeFrame":12},"Fractures","Fractures. As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.",{"measure":50,"description":50,"timeFrame":12},"All-cause mortality",{"measure":52,"description":53,"timeFrame":12},"surgery for Ulcerative colitis (UC)","surgery for Ulcerative colitis (UC). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.",null,{"allocation":54,"interventionModel":54,"interventionModelDescription":54,"primaryPurpose":54,"observationalModel":56,"timePerspective":57,"maskingInfo":54},"COHORT","PROSPECTIVE","Rationale and background:\n\nTofacitinib, an inhibitor of the Janus kinase (JAK) family of kinases, was approved in the European Union (EU) in July 2018 at a dose of 5 mg twice daily or 10 mg twice daily for the treatment of adults with moderate-to-severe ulcerative colitis (UC), who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. Malignancy excluding non-melanoma skin cancer (NMSC) is an important potential risk and venous thromboembolism (VTE) is an important identified risk associated with the use of tofacitinib, and follow-up of large cohorts of patients over a long period is needed to evaluate the risks of these safety events, as well as other potential safety events of interest, that may be associated with tofacitinib treatment. Pfizer will implement a post approval, active surveillance study of tofacitinib exposed and unexposed patients using actively collected prospective data included in the UR-CARE platform.\n\nResearch question:\n\nWhat are the incidence rates of safety events of interest in adult patients with UC treated with tofacitinib in routine clinical care, as compared to the incidence rates in patients with UC treated with other approved systemic agents, and patients with UC naïve to biologics and immunomodulators\u002Fimmunosuppressants (hereafter referred to as immunosuppressants)?\n\nStudy design:\n\nThis is an active cohort study of adult patients with UC aged ≥18 years treated with tofacitinib compared to patient receiving alternative treatment or not treatment. The study will use secondary data collected in the UR-CARE platform, which is an ongoing, prospective, observational, cohort of European Union (EU) patients with inflammatory bowel disease (IBD) with the primary aim of facilitating daily patient care and research studies in IBD. This study will focus only on patients with UC enrolled in the UR-CARE platform.\n\nVariables:\n\nThe study variables include baseline patient characteristics (i.e., clinical and demographic characteristics, comorbidities, and current and past therapies), the primary outcomes of interest, and other safety events of interest.\n\nData sources:UR-CARE will be used as the only data source.\n\nStudy size:\n\nThis study is descriptive, and all eligible patients in UR-CARE registry during the study period who have consented to participate in the study will be included, with no upper limit on the sample size.\n\nData analysis:\n\nAll statistical analysis will be performed by GETECCU using SAS software v9.4, SAS Institute Inc, Cary, NC, USA. Detailed methodology for summary and statistical analyses of data collected in this study will be documented in a statistical analysis plan (SAP).","Adult patients with UC aged ≥18 years treated with tofacitinib compared to patient receiving alternative treatment or not treatment. The study will use secondary data collected in the UR-CARE platform, which is an ongoing, prospective, observational, cohort of European Union (EU) patients with inflammatory bowel disease (IBD) with the primary aim of facilitating daily patient care and research studies in IBD. This study will focus only on patients with UC enrolled in the UR-CARE platform.",[61,64,67,70],{"label":62,"type":54,"description":63,"interventionNames":54},"Cohort 1 (Tofacitinib cohort):","Initiation of tofacitinib (i.e., first ever prescription) from 01 July 2018 through to 31 March 2025",{"label":65,"type":54,"description":66,"interventionNames":54},"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":68,"type":54,"description":69,"interventionNames":54},"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":71,"type":54,"description":72,"interventionNames":54},"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)",[74],{"name":75,"affiliation":5,"role":76},"Manuel MD Barreiro, PhD","PRINCIPAL_INVESTIGATOR",[78,83],{"name":79,"role":80,"phone":81,"phoneExt":54,"email":82},"Eva María Rodríguez","CONTACT","+34 691 08 42 07","secretariacientifica1@geteccu.org",{"name":75,"role":80,"phone":54,"phoneExt":54,"email":84},"manubarreiro@hotmail.com",[86,103,116,131,147],{"facility":87,"status":88,"city":89,"state":54,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":98,"contacts":99},"Imelda General Hospital","RECRUITING","Bonheiden","28202","Belgium","BE",{"type":94,"coordinates":95},"Point",[96,97],4.54714,51.02261,{"lat":97,"lon":96},[100],{"name":101,"role":80,"phone":54,"phoneExt":54,"email":102},"Peter BOSSUYT, MD","peter.bossuyt@imelda.be",{"facility":104,"status":88,"city":105,"state":54,"zip":106,"country":91,"countryCode":92,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"AZ Delta vzw","Roeselare","8800",{"type":94,"coordinates":108},[109,110],3.12269,50.94653,{"lat":110,"lon":109},[113],{"name":114,"role":80,"phone":54,"phoneExt":54,"email":115},"Filip BAERT, MD","filip.baert@azdelta.be",{"facility":117,"status":88,"city":118,"state":54,"zip":119,"country":120,"countryCode":121,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Acibadem City Clinic Tokuda University Hospital","Sofia","1407","Bulgaria","BG",{"type":94,"coordinates":123},[124,125],23.32415,42.69751,{"lat":125,"lon":124},[128],{"name":129,"role":80,"phone":54,"phoneExt":54,"email":130},"Anelia DECHEVA, MD","andecheva@gmail.com",{"facility":132,"status":88,"city":133,"state":134,"zip":135,"country":136,"countryCode":137,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"General Hospital of Athens \"Evangelismos\"","Ellinikó","Attica","16777","Greece","GR",{"type":94,"coordinates":139},[140,141],23.74406,37.89013,{"lat":141,"lon":140},[144],{"name":145,"role":80,"phone":54,"phoneExt":54,"email":146},"Nikolaos VIAZIS, MD","nikos.viazis@gmail.com",{"facility":148,"status":149,"city":150,"state":54,"zip":151,"country":152,"countryCode":153,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Lithuanian University of Life Sciences","NOT_YET_RECRUITING","Kaunas","44307","Lithuania","LT",{"type":94,"coordinates":155},[156,157],23.90909,54.90156,{"lat":157,"lon":156},[160],{"name":161,"role":80,"phone":54,"phoneExt":54,"email":162},"Gediminas KIUDELIS, MD","gediminas.kiudelis@kaunoklinikos.lt",{"type":164,"investigatorFullName":54,"investigatorTitle":54,"investigatorAffiliation":54,"oldNameTitle":54,"oldOrganization":54},"SPONSOR",[166],{"name":167,"class":168},"Pfizer","INDUSTRY","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":178,"type":179},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.",[184],"Ulcerative Colitis",[186],"prospective observational study with medication","2024-06-17",{"date":189,"type":190},"2024-06-21","ACTUAL",{"date":192,"type":190},"2024-01-11",{"date":194,"type":179},"2026-03-31",{"name":5,"class":6},5]