[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566734":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":10,"centralContacts":25,"locations":31,"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":63,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":34,"whyStopped":10,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Exposed cohort",null,"Pregnant individuals with a diagnosis of moderate\u002Fsevere SLE who are exposed to anifrolumab at any time during pregnancy",[13],"Drug: Anifrolumab",{"label":15,"type":10,"description":16,"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",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"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],[24],"Saphnelo",[26],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"AstraZeneca Clinical Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":10},"Research Site","RECRUITING","Wilmington","North Carolina","28401","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-77.94604,34.23556,{"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","100566734","prospective-registry-investigating-maternal-and-infant-outcomes-in-anifrolumab-users-100566734",false,"NCT06659029","Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users","PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users): The AstraZeneca Pregnancy Study for Anifrolumab","PRIMULA_Preg","Inclusion Criteria:\n\nExposed cohort\n\n1. Currently or recently (within 1 year of pregnancy outcome) pregnant\n2. Diagnosis of moderate\u002Fsevere SLE\n3. Consent to participate\n4. Authorization for their HCP(s) to provide data to the registry\n5. Exposure to at least 1 dose of anifrolumab at any time during pregnancy\n\nUnexposed cohort\n\n1. Currently or recently pregnant\n2. Diagnosis of moderate\u002Fsevere SLE\n3. Consent to participate\n4. Authorization for their HCP(s) to provide data to the registry\n5. Exposure to other products for the treatment of moderate\u002Fsevere SLE\n\nExclusion Criteria:\n\nExposed cohort\n\n1. Occurrence of pregnancy outcome prior to first contact (for enrollment) with the Virtual Research Coordination Center (retrospectively enrolled)\n2. Exposure to known teratogens and\u002For investigational medications during pregnancy\n\nUnexposed cohort\n\n1. Occurrence of pregnancy outcome prior to first contact with the Virtual Research Coordination Center (retrospectively enrolled)\n2. Exposure to known teratogens and\u002For investigational medications during pregnancy","FEMALE",{"count":61,"type":62},442,"ESTIMATED","21 Months","OBSERVATIONAL","PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users) is a prospective, observational cohort study designed to evaluate the association between anifrolumab exposure during pregnancy and subsequent adverse maternal, fetal, and infant outcomes. This study will fulfil an FDA post-marketing requirement.",[67],"Systemic Lupus Erythematosus",[69,70,71,72,73,74,67],"Chronic autoimmune disease","Immunosuppressants","Corticosteroids","Human monoclonal antibody (IgG1ƙ mAb)","Post Marketing Requirements (PMR) study","Pregnancy","2026-06-23",{"date":77,"type":78},"2026-06-24","ACTUAL",{"date":80,"type":78},"2025-07-01",{"date":82,"type":62},"2031-04-15",{"name":5,"class":6},1]