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
Who can join
All ages · Women
Full eligibility criteria
Inclusion Criteria: Exposed cohort 1. Currently or recently (within 1 year of pregnancy outcome) pregnant 2. Diagnosis of moderate/severe SLE 3. Consent to participate 4. Authorization for their HCP(s) to provide data to the registry 5. Exposure to at least 1 dose of anifrolumab at any time during pregnancy Unexposed cohort 1. Currently or recently pregnant 2. Diagnosis of moderate/severe SLE 3. Consent to participate 4. Authorization for their HCP(s) to provide data to the registry 5. Exposure to other products for the treatment of moderate/severe SLE Exclusion Criteria: Exposed cohort 1. Occurrence of pregnancy outcome prior to first contact (for enrollment) with the Virtual Research Coordination Center (retrospectively enrolled) 2. Exposure to known teratogens and/or investigational medications during pregnancy Unexposed cohort 1. Occurrence of pregnancy outcome prior to first contact with the Virtual Research Coordination Center (retrospectively enrolled) 2. Exposure to known teratogens and/or investigational medications during pregnancy
About the study
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.
What is being tested
- Anifrolumab (drug)
Sponsor: AstraZeneca · Participants: 442 · Started: Jul 1, 2025
Contact the study team
- AstraZeneca Clinical Study Information Center · Phone: 1-877-240-9479
Official record on ClinicalTrials.gov — NCT06659029
Locations in the U.S.
| North Carolina | Research Site, Wilmington |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.