[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100501494":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":116,"collaborators":10,"id":118,"slug":10,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":121,"acronym":10,"eligibilityCriteria":122,"healthyVolunteers":119,"sex":123,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":10,"studyType":129,"phases":10,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"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},[37,50,58,66,74,79,84,92,100,108],{"facility":38,"status":39,"city":40,"state":10,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":10},"Novartis Investigative Site","RECRUITING","Amadora","2720-276","Portugal","PT",{"type":45,"coordinates":46},"Point",[47,48],-9.23083,38.75382,{"lat":48,"lon":47},{"facility":38,"status":39,"city":51,"state":10,"zip":52,"country":42,"countryCode":43,"cosmosGeoPoint":53,"geoPoint":57,"contacts":10},"Guimarães","4835-044",{"type":45,"coordinates":54},[55,56],-8.29619,41.44443,{"lat":56,"lon":55},{"facility":38,"status":39,"city":59,"state":10,"zip":60,"country":42,"countryCode":43,"cosmosGeoPoint":61,"geoPoint":65,"contacts":10},"Leiria","2410-104",{"type":45,"coordinates":62},[63,64],-8.80705,39.74362,{"lat":64,"lon":63},{"facility":38,"status":39,"city":67,"state":10,"zip":68,"country":42,"countryCode":43,"cosmosGeoPoint":69,"geoPoint":73,"contacts":10},"Lisbon","1169 050",{"type":45,"coordinates":70},[71,72],-9.1498,38.72509,{"lat":72,"lon":71},{"facility":38,"status":39,"city":67,"state":10,"zip":75,"country":42,"countryCode":43,"cosmosGeoPoint":76,"geoPoint":78,"contacts":10},"1349-019",{"type":45,"coordinates":77},[71,72],{"lat":72,"lon":71},{"facility":38,"status":39,"city":67,"state":10,"zip":80,"country":42,"countryCode":43,"cosmosGeoPoint":81,"geoPoint":83,"contacts":10},"1649 035",{"type":45,"coordinates":82},[71,72],{"lat":72,"lon":71},{"facility":38,"status":39,"city":85,"state":10,"zip":86,"country":42,"countryCode":43,"cosmosGeoPoint":87,"geoPoint":91,"contacts":10},"Matosinhos Municipality","4454 513",{"type":45,"coordinates":88},[89,90],-8.68908,41.18207,{"lat":90,"lon":89},{"facility":38,"status":39,"city":93,"state":10,"zip":94,"country":42,"countryCode":43,"cosmosGeoPoint":95,"geoPoint":99,"contacts":10},"Ponte de Lima","4990 041",{"type":45,"coordinates":96},[97,98],-8.58393,41.76719,{"lat":98,"lon":97},{"facility":38,"status":39,"city":101,"state":10,"zip":102,"country":42,"countryCode":43,"cosmosGeoPoint":103,"geoPoint":107,"contacts":10},"Porto","4200 319",{"type":45,"coordinates":104},[105,106],-8.61097,41.1485,{"lat":106,"lon":105},{"facility":38,"status":39,"city":109,"state":10,"zip":110,"country":42,"countryCode":43,"cosmosGeoPoint":111,"geoPoint":115,"contacts":10},"Setúbal","2910-446",{"type":45,"coordinates":112},[113,114],-8.8882,38.5244,{"lat":114,"lon":113},{"type":117,"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":127,"type":128},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.",[132],"Relapsing Multiple Sclerosis",[132,134,21,135,42],"RMS","NIS","2025-01-12",{"date":138,"type":139},"2025-01-14","ACTUAL",{"date":141,"type":139},"2023-11-27",{"date":143,"type":128},"2026-09-15",{"name":28,"class":6},10]