[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656697":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":11,"studyPopulation":34,"armGroups":35,"interventions":49,"overallOfficials":57,"centralContacts":61,"locations":69,"responsibleParty":83,"collaborators":11,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":87,"sex":93,"minAge":94,"maxAge":11,"enrollmentInfo":95,"targetDuration":11,"studyType":98,"phases":11,"briefSummary":99,"conditions":100,"keywords":11,"overallStatus":72,"whyStopped":11,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of Satisfied\u002FVery Satisfied Responses on the Treatment Administration Satisfaction Questionnaire (TASQ) - Satisfaction Item Score at Month 12",null,"At Month 12",[14,16,19,22,24,26,29],{"measure":15,"description":11,"timeFrame":12},"Proportion of Convenient \u002F Very Convenient Responses on the TASQ Convenience Item Score at Month 12",{"measure":17,"description":11,"timeFrame":18},"Change From Baseline in Serum Neurofilament Light Chain (NfL) at Months 6 and 12","Baseline, Months 6 and 12",{"measure":20,"description":11,"timeFrame":21},"Annualized Relapse Rate (ARR) From Baseline to Month 12","Baseline to Month 12",{"measure":23,"description":11,"timeFrame":21},"Proportion of Relapse-Free Participants From Baseline Through Month 12 Following Ocrelizumab s.c. Initiation",{"measure":25,"description":11,"timeFrame":21},"Proportion of Participants Persistent on Treatment From Baseline Through Month 12",{"measure":27,"description":11,"timeFrame":28},"Incidence, Severity and Outcomes of Adverse Events (AEs)","Up to 2.6 years",{"measure":30,"description":11,"timeFrame":28},"Duration of AEs",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":32,"timePerspective":33,"maskingInfo":11},"COHORT","PROSPECTIVE","The study population will consist of participants diagnosed with RRMS who are treated with ocrelizumab s.c. for the first time (initial treatment or treatment switch) as part of their multiple sclerosis (MS) therapy during routine clinical practice",[36,41,45],{"label":37,"type":11,"description":38,"interventionNames":39},"Cohort 1","Treatment-naive participants initiating ocrelizumab s.c., as outlined in the protocol will be observed for 12 months to characterize participant satisfaction following initiation of ocrelizumab s.c.",[40],"Drug: Ocrelizumab",{"label":42,"type":11,"description":43,"interventionNames":44},"Cohort 2","Participants who were receiving ocrelizumab i.v. and then switched to ocrelizumab s.c., representing a change in route of administration as outlined in the protocol will be observed for 12 months to characterize participant satisfaction following initiation of ocrelizumab s.c.",[40],{"label":46,"type":11,"description":47,"interventionNames":48},"Cohort 3","Treatment experienced participants who were receiving prior DMTs and then switched to ocrelizumab s.c., as outlined in the protocol will be observed for 12 months to characterize participant satisfaction following initiation of ocrelizumab s.c.",[40],[50],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"DRUG","Ocrelizumab","Ocrelizumab will be administered at the discretion of the physician per local clinical practice and local labeling.",[37,42,46],[56],"Ocrevus",[58],{"name":59,"affiliation":5,"role":60},"Clinical Trials","STUDY_DIRECTOR",[62,67],{"name":63,"role":64,"phone":65,"phoneExt":11,"email":66},"Reference Study ID Number: MN46738 https:\u002F\u002Fforpatients.roche.com\u002F No attachments to email below.","CONTACT","888-662-6728","global-roche-genentech-trials@gene.com",{"name":68,"role":64,"phone":11,"phoneExt":11,"email":11},"Fastest response: use the inquiry form. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",[70],{"facility":71,"status":72,"city":73,"state":11,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":11},"University Medical Centre","RECRUITING","Ljubljana","1000","Slovenia","SI",{"type":78,"coordinates":79},"Point",[80,81],14.50513,46.05108,{"lat":81,"lon":80},{"type":84,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100656697","non-interventional-study-of-subcutaneous-ocrelizumab-in-persons-with-relapsing-remitting-multiple-sclerosis-100656697",false,"NCT07827586","Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis","A Prospective Longitudinal Multicenter, Multi-Country, Observational Study Assessing Patient Satisfaction After Subcutaneous Ocrelizumab Administration in Persons With Relapsing-Remitting Multiple Sclerosis (SONATA-MS)","SONATA-MS","Inclusion Criteria:\n\n* Diagnosis of RRMS according to the revised McDonald criteria (2017 or 2024 revisions).\n* Initiation of ocrelizumab s.c in accordance with routine clinical practice and local prescribing information.\n* The decision to initiate ocrelizumab s.c. has been made by the treating physician prior to and independently of study participation.\n* Willingness to complete the patient-reported outcome questionnaire TASQ, where applicable.\n\nExclusion Criteria:\n\n* Participation in any clinical study involving disease modifying therapies for multiple sclerosis during the study period or at the time of enrollment.\n* Prior treatment with rituximab.\n* Contraindications to ocrelizumab as per the local prescribing information.\n* Severe psychiatric or cognitive impairment that, in the opinion of the treating physician, would preclude informed consent, reliable participation in the study, or completion of patient-reported outcomes.\n* Any condition which, in the opinion of the treating physician, would interfere with participation in the study or the interpretation of study results.\n* For participants participating in a Market Research and Patient Support Program (MAP), inclusion is permitted only when a cross-reference to the unique MAP patient identifier is available.","ALL","18 Years",{"count":96,"type":97},1800,"ESTIMATED","OBSERVATIONAL","The main purpose of the study is to assess patient-reported satisfaction with subcutaneous (s.c.) ocrelizumab administration in participants with relapsing-remitting multiple sclerosis (RRMS) who are treatment-naive, switching from intravenous (i.v.) ocrelizumab to s.c. ocrelizumab, or switching from a prior disease-modifying therapy (DMT) to s.c. ocrelizumab.",[101],"Relapsing-Remitting Multiple Sclerosis","2026-09-25",{"date":104,"type":105},"2026-09-28","ACTUAL",{"date":107,"type":97},"2026-09-30",{"date":109,"type":97},"2029-05-31",{"name":5,"class":6},1]