[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596759":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":15,"locations":21,"responsibleParty":35,"collaborators":37,"id":40,"slug":10,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":41,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":10,"studyType":53,"phases":10,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":24,"whyStopped":10,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Exposed cohort",null,"Pregnant individuals with a diagnosis of SLE who are exposed to anifrolumab at any time during pregnancy",{"label":13,"type":10,"description":14,"interventionNames":10},"Unexposed cohort","Pregnant individuals with a diagnosis of moderate\u002Fsevere SLE who are not exposed to anifrolumab at any time during pregnancy but who are exposed to other products for the treatment of SLE",[16],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},"AstraZeneca Clinical Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",[22],{"facility":23,"status":24,"city":25,"state":26,"zip":27,"country":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":10},"Research Site","RECRUITING","Cary","North Carolina","27513","United States",{"type":30,"coordinates":31},"Point",[32,33],-78.78112,35.79154,{"lat":33,"lon":32},{"type":36,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[38],{"name":39,"class":6},"IQVIA Pty Ltd","100596759",false,"NCT07049653","Anifrolumab Pregnancy Study","A Non-Interventional Multi-Database Post-Authorisation Study to Assess Pregnancy-Related Safety Data From Women With SLE Exposed to Anifrolumab","ROSE","Inclusion criteria for EXPOSED SOURCE POPULATION:\n\n* Women with a continuous enrolment in the database for ≥ 12 months prior to LMP2\n* Women diagnosed with SLE before pregnancy\n* Women exposed to anifrolumab (polytherapy, added to SLE SOC) during pregnancy and\u002For 16-week period prior to LMP2\n\nExclusion criteria for EXPOSED SOURCE POPULATION:\n\n\\- Pregnancies whose date of conception cannot be established\n\nInclusion criteria for UNEXPOSED SOURCE POPULATION:\n\n* Women with a continuous enrolment in the database for ≥ 12 months prior to LMP2\n* Women diagnosed with SLE before pregnancy\n* Women treated with SLE SOC during pregnancy\n\nExclusion criteria for UNEXPOSED SOURCE POPULATION:\n\n* Women treated with anifrolumab during pregnancy and\u002For 16-week period prior to LMP2\n* Pregnancies whose date of conception cannot be established\n\nInclusion criteria for EXPOSED and UNEXPOSED STUDY POPULATION:\n\n\\- Women with moderate\u002Fsevere SLE\n\nExclusion criteria for EXPOSED and UNEXPOSED STUDY POPULATION:\n\n* Women with a history of CM or chromosomal abnormalities (according to available records), before delivery\n* Women prescribed a confirmed teratogenic drug prior to LMP2 with a time period of 5-half-lives of relevant drug or during pregnancy","FEMALE","18 Years","130 Years",{"count":51,"type":52},500,"ESTIMATED","OBSERVATIONAL","This is a non-interventional multi-database post-authorisation study to assess pregnancy-related safety data from women with SLE exposed to Anifrolumab.",[56],"Systemic Lupus Erythematosus",[58],"pregnancy, anifrolumab, SLE","2026-06-23",{"date":61,"type":62},"2026-06-26","ACTUAL",{"date":64,"type":62},"2026-06-04",{"date":66,"type":52},"2030-12-10",{"name":5,"class":6},1]