NCT06594068
Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users
Recruiting · Phase 4 · AstraZeneca · registry updated 2026-09-16
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- years or older
- Signed informed consent to participate
- Diagnosis of moderate/severe SLE
- Ongoing treatment with anifrolumab
- 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)
- 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)
Exclusion
- 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
- Diagnosis of lupus nephritis in the last 12 months
- History of breast implants, breast augmentation, or breast reduction surgery that significantly impacts breastfeeding or collection of milk from 1 or both breasts
- History of malignancy in the last 10 years
- History of mastectomy
- Evidence of mastitis or any other significant active infection at Day 1 (pre-dose)