[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637069":3},{"organization":4,"outcomesModule":7,"designInfo":51,"detailedDescription":52,"studyPopulation":53,"armGroups":54,"interventions":60,"overallOfficials":11,"centralContacts":66,"locations":72,"responsibleParty":88,"collaborators":11,"id":90,"slug":11,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":11,"studyType":102,"phases":11,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":112,"whyStopped":11,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"University Hospital, Lille","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Slope of serum immunoglobulin G (IgG) levels during ocrelizumab treatment period (minimum 18 months)",null,"42 months",{"measure":14,"description":11,"timeFrame":12},"Slope of serum immunoglobulin G (IgG) levels during ofatumumab treatment period (24 months)",[16,19,22,25,27,29,31,33,35,37,39,41,43,45,47,49],{"measure":17,"description":11,"timeFrame":18},"Age at baseline (years)","Baseline",{"measure":20,"description":11,"timeFrame":21},"Number and percentage of patients with stable serum IgG levels","24 months",{"measure":23,"description":11,"timeFrame":24},"Number of severe infections occurring during ocrelizumab treatment period prior to switch to ofatumumab","18 months",{"measure":26,"description":11,"timeFrame":21},"Slope of serum immunoglobulin M (IgM) levels during ocrelizumab treatment period (minimum 18 months)",{"measure":28,"description":11,"timeFrame":21},"Distribution of Expanded Disability Status Scale (EDSS) scores after switch to ofatumumab",{"measure":30,"description":11,"timeFrame":21},"Number of patients who discontinued ofatumumab before the end of follow-up",{"measure":32,"description":11,"timeFrame":21},"Number and type of adverse events (AEs) during ofatumumab follow-up period",{"measure":34,"description":11,"timeFrame":18},"Disease duration (years since diagnosis)",{"measure":36,"description":11,"timeFrame":18},"Sex distribution (male\u002Ffemale, %)",{"measure":38,"description":11,"timeFrame":21},"Number and percentage of patients with increased serum IgG levels",{"measure":40,"description":11,"timeFrame":21},"Slope of serum immunoglobulin M (IgM) levels during ofatumumab treatment period (24 months)",{"measure":42,"description":11,"timeFrame":21},"Distribution of Fatigue Severity Scale (FSS) scores after switch to ofatumumab",{"measure":44,"description":11,"timeFrame":21},"Distribution of Multiple Sclerosis Functional Composite (MSFC) scores after switch to ofatumumab",{"measure":46,"description":11,"timeFrame":21},"Number of relapses per patient after switch to ofatumumab",{"measure":48,"description":11,"timeFrame":21},"Reasons for discontinuation of ofatumumab before the end of follow-up",{"measure":50,"description":11,"timeFrame":21},"Number and type of serious adverse events (SAEs) during ofatumumab follow-up period",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":6,"timePerspective":6,"maskingInfo":11},"time perspective: retrospective and prospective","The study population will be adult patients with MS (women and men) who initiate treatment with ofatumumab after a treatment with ocrelizumab",[55],{"label":56,"type":11,"description":57,"interventionNames":58},"Ofatumumab","Adult patients (≥18 years) with relapsing multiple sclerosis treated with ocrelizumab for at least 18 months and already switched or switching from ocrelizumab to ofatumumab treatment",[59],"Drug: ofatumumab",[61],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":11},"DRUG","ofatumumab","There is no treatment allocation. Participants with MS that initiated treatment with ofatumumab (Kesimpta ®) as per neurologist practice and regardless of the study protocol.",[56],[67],{"name":68,"role":69,"phone":70,"phoneExt":11,"email":71},"PATRICK VERMERSCH, Pr","CONTACT","06.33.38.32.60","patrick.vermersch@chu-lille.fr",[73],{"facility":74,"status":11,"city":75,"state":11,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"CHU de Lille","Lille","59000","France","FR",{"type":80,"coordinates":81},"Point",[82,83],3.05512,50.63391,{"lat":83,"lon":82},[86],{"name":87,"role":69,"phone":70,"phoneExt":11,"email":71},"Patrick VERMERSCH, Dr",{"type":89,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100637069",false,"NCT07625800","Switch to Ofatumumab and Level of Immunoglobulins","SOLI","Inclusion Criteria:\n\n1. Adult patients (≥ 18 years old) who had been treated with ocrelizumab for a relapsing form of Multiple Sclerosis according to the ocrelizumab marketing authorization (MA) treatment regimen for at least 18 months.\n2. Patients with a decrease of IgG at a minimum of two consecutive dosages (around six months apart) during ocrelizumab treatment\\*.\n3. Patients already switched or switching from ocrelizumab to ofatumumab treatment (decision independent from the study\\*).\n4. Patients agreeing to participate to the study.\n5. Able to provide their non-opposition\n\n   * At the discretion of the investigator, if a benefit for patients is expected based on their experience and depending on patient's characteristics\n\nExclusion Criteria:\n\n1. Patients with ocrelizumab dose spacing \\> 8 months in the last 18 months before switch\n2. Patient who underwent an immunoglobulin supplementation therapy within 18 months before the switch\n3. Ongoing or planned pregnancy","ALL","18 Years","65 Years",{"count":100,"type":101},115,"ESTIMATED","OBSERVATIONAL","This real-life study aims to describe IgG levels after switching from ocrelizumab 600 mg IV every 6 to 8 months in Patients with Multiple Sclerosis (PwMS) to ofatumumab 20 mg SC every month and showing a decreasing level of IgG during treatment by ocrelizumab in real life practice in France over 24 months of follow-up.\n\nThe primary objective is therefore to determine if the downward trend of IgG observed during ocrelizumab treatment is modified after a switch to ofatumumab, in PwMS treated during at least 18 months of ocrelizumab in real life practice, over 24 months of follow-up.",[105],"Multiple Sclerosis",[105,107,56,108,109,110,111],"NIS","Kesimpta","Ocrelizumab","IgG","IgM","NOT_YET_RECRUITING","2026-05-28",{"date":115,"type":116},"2026-06-04","ACTUAL",{"date":118,"type":101},"2026-06",{"date":120,"type":101},"2029-06",{"name":5,"class":6},1]