[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100501494":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":115,"collaborators":10,"id":117,"slug":10,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":120,"acronym":10,"eligibilityCriteria":121,"healthyVolunteers":118,"sex":122,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":10,"studyType":128,"phases":10,"briefSummary":129,"conditions":130,"keywords":132,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1: Early treatment arm",null,"All patients who initiated Ofatumumab within 3 years after MS diagnosis (can be treatment-naive or switch).",[13],"Other: Ofatumumab",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2: Late treatment arm","All patients who initiated Ofatumumab with more than 3 years of MS diagnosis.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"OTHER","Ofatumumab","There is no treatment allocation. Ofatumumab will be prescribed by the physician as per locally approved label. No drug will be dispensed from Novartis",[9,15],[25],"Kesimpta",[27],{"name":28,"affiliation":28,"role":29},"Novartis Pharmaceuticals","STUDY_DIRECTOR",[31,35],{"name":28,"role":32,"phone":33,"phoneExt":10,"email":34},"CONTACT","+41613241111","novartis.email@novartis.com",{"name":28,"role":32,"phone":10,"phoneExt":10,"email":10},[37,49,57,65,73,78,83,91,99,107],{"facility":38,"status":39,"city":40,"state":10,"zip":41,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":10},"Novartis Investigative Site","RECRUITING","Amadora","2720-276","Portugal",{"type":44,"coordinates":45},"Point",[46,47],-9.23083,38.75382,{"lat":47,"lon":46},{"facility":38,"status":39,"city":50,"state":10,"zip":51,"country":42,"cosmosGeoPoint":52,"geoPoint":56,"contacts":10},"Guimarães","4835-044",{"type":44,"coordinates":53},[54,55],-8.29619,41.44443,{"lat":55,"lon":54},{"facility":38,"status":39,"city":58,"state":10,"zip":59,"country":42,"cosmosGeoPoint":60,"geoPoint":64,"contacts":10},"Leiria","2410-104",{"type":44,"coordinates":61},[62,63],-8.80705,39.74362,{"lat":63,"lon":62},{"facility":38,"status":39,"city":66,"state":10,"zip":67,"country":42,"cosmosGeoPoint":68,"geoPoint":72,"contacts":10},"Lisbon","1169 050",{"type":44,"coordinates":69},[70,71],-9.1498,38.72509,{"lat":71,"lon":70},{"facility":38,"status":39,"city":66,"state":10,"zip":74,"country":42,"cosmosGeoPoint":75,"geoPoint":77,"contacts":10},"1349-019",{"type":44,"coordinates":76},[70,71],{"lat":71,"lon":70},{"facility":38,"status":39,"city":66,"state":10,"zip":79,"country":42,"cosmosGeoPoint":80,"geoPoint":82,"contacts":10},"1649 035",{"type":44,"coordinates":81},[70,71],{"lat":71,"lon":70},{"facility":38,"status":39,"city":84,"state":10,"zip":85,"country":42,"cosmosGeoPoint":86,"geoPoint":90,"contacts":10},"Matosinhos Municipality","4454 513",{"type":44,"coordinates":87},[88,89],-8.68908,41.18207,{"lat":89,"lon":88},{"facility":38,"status":39,"city":92,"state":10,"zip":93,"country":42,"cosmosGeoPoint":94,"geoPoint":98,"contacts":10},"Ponte de Lima","4990 041",{"type":44,"coordinates":95},[96,97],-8.58393,41.76719,{"lat":97,"lon":96},{"facility":38,"status":39,"city":100,"state":10,"zip":101,"country":42,"cosmosGeoPoint":102,"geoPoint":106,"contacts":10},"Porto","4200 319",{"type":44,"coordinates":103},[104,105],-8.61097,41.1485,{"lat":105,"lon":104},{"facility":38,"status":39,"city":108,"state":10,"zip":109,"country":42,"cosmosGeoPoint":110,"geoPoint":114,"contacts":10},"Setúbal","2910-446",{"type":44,"coordinates":111},[112,113],-8.8882,38.5244,{"lat":113,"lon":112},{"type":116,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100501494",false,"NCT05809986","Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study","Inclusion Criteria:\n\nTo participate in the study, all the following inclusion criteria must be met:\n\n* Patients aged 18 years or older\n* Written informed consent obtained before participating in the study.\n* Patient is willing and able to complete the assessments, including PRO questionnaires, as outlined in this study.\n* Diagnosis of RMS per McDonald Criteria (2017) occurred prior to initiation of Ofatumumab.\n* Treatment with Ofatumumab is in accordance with the Portuguese indication of Kesimpta® (i.e., treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features).\n* Patients that have initiated Ofatumumab up to 12 M prior inclusion in the study OR Patients that are initiating Ofatumumab at the moment of study inclusion.\n\nExclusion Criteria:\n\nTo participate in the study, none of the following exclusion criteria must be met:\n\n* Use of investigational drugs during the study, OR between Ofatumumab initiation and inclusion into the study, OR within 5 half-lives of investigational drug before Ofatumumab initiation, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer.\n* Use of high efficacy therapy (including Ocrelizumab, Natalizumab, Mitoxantrone, Rituximab and Alemtuzumab) in both cohorts prior to the initiation of Ofatumumab.","ALL","18 Years","99 Years",{"count":126,"type":127},174,"ESTIMATED","OBSERVATIONAL","This non-interventional study will compare the effect of Ofatumumab treatment between patients that began Ofatumumab within the 3 years after Multiple Sclerosis diagnosis and patients that began Ofatumumab with more than 3 years of Multiple Sclerosis diagnosis in a real-world setting in Portugal.",[131],"Relapsing Multiple Sclerosis",[131,133,21,134,42],"RMS","NIS","2025-01-12",{"date":137,"type":138},"2025-01-14","ACTUAL",{"date":140,"type":138},"2023-11-27",{"date":142,"type":127},"2026-09-15",{"name":28,"class":6},10]