Overview

Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users

Status:
RECRUITING
Trial end date:
2027-08-31
Target enrollment:
Participant gender:
Summary
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 receive anifrolumab therapeutically.
Phase:
PHASE4
Details
Lead Sponsor:
AstraZeneca
Collaborator:
PPD Development, LP
Treatments:
anifrolumab