[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604449":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":38,"centralContacts":43,"locations":52,"responsibleParty":68,"collaborators":71,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":10,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":10,"enrollmentInfo":87,"targetDuration":10,"studyType":90,"phases":10,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":99,"whyStopped":10,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Region Stockholm","OTHER_GOV",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Women with MS during pregnancy",null,"Women over 18 years of age with the diagnosis of multiple sclerosis, regardless of treatment, or no treatment, that have successfully delivered or will deliver a child",[13,14,15],"Drug: monoclonal CD-20 antibodies","Drug: No Drug","Drug: Other treatment",{"label":17,"type":10,"description":18,"interventionNames":19},"Infants born to women with MS","Infants born to women with multiple sclerosis",[13,14,15],[21,30,34],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","monoclonal CD-20 antibodies","Treatment with monoclonal CD-20 antibodies 6 months before or during pregnancy",[17,9],[27,28,29],"rituximab","ocrelizumab","ofatumumab",{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":10},"No Drug","No medication",[17,9],{"type":22,"name":35,"description":36,"armGroupLabels":37,"otherNames":10},"Other treatment","Any other immune modulating treatment",[17,9],[39],{"name":40,"affiliation":41,"role":42},"Katharina Fink, MD, Dr. med.","Karolinska Institutet","STUDY_DIRECTOR",[44,48],{"name":40,"role":45,"phone":46,"phoneExt":10,"email":47},"CONTACT","+46706571789","Katharina.fink@regionstockholm.se",{"name":49,"role":45,"phone":50,"phoneExt":10,"email":51},"Greta Mirzaoff, MD","08-123 400 00","greta.lundborg-mirzaoff@regionstockholm.se",[53],{"facility":54,"status":10,"city":55,"state":10,"zip":10,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Academic specialist center, Center for Neurology","Stockholm","Sweden","SE",{"type":59,"coordinates":60},"Point",[61,62],18.06871,59.32938,{"lat":62,"lon":61},[65,66],{"name":49,"role":45,"phone":50,"phoneExt":10,"email":51},{"name":49,"role":67,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"type":67,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Katharina Fink","MD, Dr. med.",[72,74,77],{"name":73,"class":6},"The Swedish Research Council",{"name":75,"class":76},"Haukeland University Hospital","OTHER",{"name":41,"class":76},"100604449","immune-system-effects-in-children-born-to-women-with-multiple-sclerosis-treated-with-monoclonal-antibody-therapy-during-pregnancy-100604449",false,"NCT07149662","Immune System Effects in Children Born to Women With Multiple Sclerosis Treated With Monoclonal Antibody Therapy During Pregnancy","B-cellspåverkan i Barn Till Kvinnor Med Multipel Skleros Och Rituximabbehandling före Eller Under Graviditeten (B-cell Effects in Children Born to Women With Multiple Sclerosis and Rituximab Treatment Before or During Pregnancy)","Inclusion Criteria:\n\n* Established multiple sclerosis diagnosis\n* Rituximab, ocrelizumab, ofatumumab or other monoclonal CD-20 antibody has been administered within 6 (12) months prior to or during pregnancy\n* Other immun modulation treatment has been administered within 6 (12) months prior to or during pregnancy\n* No treatment has been administered within 6 (12) months prior to or during pregnancy\n\nExclusion Criteria:\n\n\\- Previous stem cell transplantation","FEMALE","18 Years",{"count":88,"type":89},111,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn about consequences for the child when the mother is treated with rituximab (or other monoclonal CD-20 antibodies) before or during pregnancy. The main questions it aims to answer are:\n\n* Is the infant's immune system effected with lower levels of B-cell markers, higher rates of infections or poor vaccine response?\n* Are the monoclonal CD20-antibodies fully eliminated in women treated within 6 (12) months prior to conception?\n\nParticipants will:\n\n* At the time of clinical routine blood sampling (at the end of each trimester) the becoming mother will give some additional blood samples for analysis of drug concentration\n* Within the first year postpartum the child will leave a blood sample to detect antibodies induced by vaccination or infections\n* Within our routine contacts with the participant (mother) will be asked about infections in both the mother and the child",[93,94],"Multiple Sclerosis","Pregnancy",[93,96,97,98,23,94],"Rituximab","Ocrelizumab","Ofatumumab","NOT_YET_RECRUITING","2025-11-20",{"date":102,"type":103},"2025-11-25","ACTUAL",{"date":105,"type":89},"2026-02",{"date":107,"type":89},"2028-03",{"name":5,"class":6},1]