[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561738":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":47,"collaborators":49,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":20,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Anifrolumab (IV administration and SC administration)","EXPERIMENTAL","For participants with IV administration, milk will be collected at 14 timepoints: 1 pre-dose (spot) and 13 post-dose: Day 1 \\[0-4, 4-8, 8-12, 12-18, 18-24 hours\\], Day 3 \\[48 hours\\], Day 4 (spot), Day 6 (spot), Day 8 (spot), Day 12 (spot), Day 16 (spot), Day 22 (spot), and Day 29 (prior to next dose, spot). Maternal serum collection: Day 1 (pre-dose and 0-4 hours post-dose), Day 12, and Day 29. Infant serum collection: Day 30 after the next dose and after 24 hours of breastfeeding. Total duration of participation will be 1 month. For participants with SC administration, the total duration of participation will be 9 days. Milk will be collected at 10 timepoints: 1 pre-dose (spot) and 9 post-dose: Day 1 \\[0-4, 4-8, 8-12, 12-18, 18-24 hours\\], Day 3 \\[48 hours\\], Day 4 (spot), Day 6 (spot), Day 8 (prior to next dose, spot). Maternal serum collection: Day 1 (pre-dose and 0-4 hours postdose), and Day 8. Infant serum collection: Day 9 after the next dose and after 24 hours of breastfeeding.",[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 (Furie et al., 2017). Clinical trial evidence from TULIP 1, 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 (Furie et al., 2019; Morand et al., 2020). The phase II MUSE study showed that administration of anifrolumab resulted in substantially reduced disease activity, measured by the SLE Responder Index, compared to patients receiving placebo (Furie et al., 2017). These data resulted with applications to the FDA and the EMA, leading to approvals in July 2021 and February 2022, for the treatment of adult patients with moderate to severe SLE who are receiving standard therapy.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Darin Brimhall, MD","PPD, Las Vegas, US","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"AstraZeneca Clinical Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":20},"Research Site","RECRUITING","Las Vegas","Nevada","89113","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-115.13722,36.17497,{"lat":45,"lon":44},{"type":48,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[50],{"name":51,"class":6},"PPD Development, LP","100561738","phase-4-prospective-registry-investigating-maternal-infant-and-lactation-outcomes-in-anifrolumab-users-100561738",false,"NCT06594068","Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users","PRIMULA Lac (Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users): The AstraZeneca Lactation Study for Anifrolumab","PRIMULA Lac","Inclusion Criteria:\n\nMaternal:\n\n1. 18 years or older\n2. Signed informed consent to participate\n3. Diagnosis of moderate\u002Fsevere SLE\n4. Ongoing treatment with anifrolumab\n5. Has reached or will reach steady state (\\~85 days postpartum, equivalent to at least 3 consecutive previous IV doses or at least 12 previous SC doses during the post-partum period) with anifrolumab by the time of study Day 1 (pre-dose milk collection)\n6. Established lactation in the index post-partum period (breastfeeding or pumping for at least 4 weeks at time of Day 1 visit to ensure mature milk production)\n7. Willing to breastfeed or pump regularly during the study period to maintain milk supply and exclusively pump breast milk for the 24-hour period of breast milk collection on Day 1 post IV dose\n8. Plans to continue feeding infant breast milk at least throughout the duration of the study and is not weaning\n9. Must be exclusively breast milk-feeding their infant (or if not exclusively breast milk-feeding, not providing more than 1 supplemental bottle of formula per day) at the time of enrollment and throughout the study period\n10. Agrees to use only lanolin nipple cream during the sampling period\n\nInfant:\n\n1. Gestational age at delivery ≥32 weeks\n2. Birthweight \\> 10th percentile\n3. Weight \\> 10th percentile at the time of enrollment\n\nExclusion Criteria:\n\nMaternal:\n\n1. Received any investigational compound or approved biologic or biosimilar within 30 days or 5 half-lives (whichever is longer) prior to enrollment in the study\n2. Diagnosis of lupus nephritis in the last 12 months\n3. History of breast implants, breast augmentation, or breast reduction surgery that significantly impacts breastfeeding or collection of milk from 1 or both breasts\n4. History of malignancy in the last 10 years\n5. History of mastectomy\n6. Evidence of mastitis or any other significant active infection at Day 1 (pre-dose)\n\nInfant:\n\n1\\. Any abnormality noted or clinically significant medical condition, including cardiac, pulmonary, and liver disease, glucose instability, or active infection at the time of screening that, in the opinion of the investigator, may make implementation of the protocol or interpretation of the trial difficult or would put the infant participant at risk by participating in the study","FEMALE","18 Years","130 Years",{"count":64,"type":65},16,"ESTIMATED","INTERVENTIONAL",[68],"PHASE4","Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users (PRIMULA Lac) is a Post Marketing Requirements (PMR) study designed to fulfill the FDA post-marketing requirements. The study will collect data about the presence of anifrolumab in human breast milk and serum (maternal and infant) among lactating individuals who are receiving anifrolumab therapeutically via intravenous (IV) or subcutaneous (SC) administration and evaluate exposure and effects on the breastfed infant.",[71],"Systemic Lupus Erythematosus",[73,74,75,76,77,78],"Chronic autoimmune disease","Immunosuppressants","Corticosteroids","Human monoclonal antibody (IgG1ƙ mAb)","Post Marketing Requirements (PMR) study","Systemic Lupus Erythematosus (SLE)","2026-06-24",{"date":81,"type":82},"2026-06-26","ACTUAL",{"date":84,"type":82},"2026-01-16",{"date":86,"type":65},"2027-08-31",{"name":5,"class":6},1]