[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577253":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":33,"responsibleParty":46,"collaborators":48,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":10,"maxAge":10,"enrollmentInfo":60,"targetDuration":10,"studyType":63,"phases":10,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Anifrolumab exposed pregnancies",null,"The primary analysis cohort will be prospectively reported pregnancies with anifrolumab exposure anytime from 16 weeks prior to date of conception (DOC) until pregnancy outcome.",[13],"Drug: Anifrolumab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Anifrolumab","Anifrolumab is a human monoclonal antibody that binds to subunit 1 of the type 1 interferon receptor,which was developed based on the evidence supporting the role of type 1 interferon pathway in SLE. Clinical trial evidence from TULIP 1 and TULIP 2 have showed that monthly intravenous administration of anifrolumab led to a higher percentage of patients with a response, assessed with the British Isles Lupus Assessment Group-based Composite Lupus Assessment, compared with patients receiving placebo. Moreover, the phase II MUSE study showed that administration of anifrolumab resulted in substantially reduce disease activity, as measured by the SLE Responder Index,compared to patients receiving placebo. Anifrolumab was approved by the FDA and EMA in July 2021 and February 2022,respectively, for the treatment of adult patients with moderate to severe SLE who are receiving standard therapy.",[9],[21],"Saphnelo",[23],{"name":24,"affiliation":25,"role":26},"Syd Philips","PPD Miami, US","PRINCIPAL_INVESTIGATOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":10,"email":32},"AstraZeneca Clinical Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",[34],{"facility":35,"status":36,"city":37,"state":10,"zip":10,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":10},"Reseach Facility","RECRUITING","Södertälje","Sweden","SE",{"type":41,"coordinates":42},"Point",[43,44],17.62525,59.19554,{"lat":44,"lon":43},{"type":47,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[49],{"name":50,"class":6},"PPD Development, LP","100577253","the-anifrolumab-prim-program-100577253",false,"NCT06795893","The Anifrolumab PRIM Program","Pregnancy and Infant Outcomes in Anifrolumab Exposed Pregnancies Using PRegnancy Outcomes Intensive Monitoring (PRIM) Data: The Anifrolumab PRIM Program","PRIM","Inclusion Criteria:\n\n* Currently or recently (within 1 year of pregnancy outcome) pregnant\n* Exposure to at least 1 dose of anifrolumab at any time during pregnancy or in the 16 weeks prior to date of conception\n\nExclusion Criteria:\n\n* Pregnancy cases that have been enrolled in the prospective pregnancy registry (D3461R00051), those reported prior to the start of the PRIM program, or those that have been exposed to known teratogens or investigational medications will be excluded from the anifrolumab PRIM study.","FEMALE",{"count":61,"type":62},240,"ESTIMATED","OBSERVATIONAL","Pregnancy and infant outcomes in anifrolumab exposed pregnancies using PRegnancy outcomes Intensive Monitoring (PRIM) data: The anifrolumab PRIM program",[66],"Systemic Lupus Erythematosus",[68,69,70,71,72,73,66],"chronic autoimmune disease","immunosuppressants","corticosteroids","human monoclonal antibody (IgG1ƙ mAb)","post Marketing Requirements (PMR) study","pregnancy","2026-08-10",{"date":76,"type":77},"2026-08-11","ACTUAL",{"date":79,"type":77},"2025-11-07",{"date":81,"type":62},"2031-04-15",{"name":5,"class":6},1]