Actively Recruiting
Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users
Led by AstraZeneca · Updated on 2026-04-17
442
Participants Needed
1
Research Sites
302 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
P
PPD Development, LP
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Currently or recently (within 1 year of pregnancy outcome) pregnant
- Diagnosis of moderate/severe systemic lupus erythematosus (SLE)
- Consent to participate in the study
- Authorization for healthcare providers to share medical data with the registry
- Exposure to at least one dose of anifrolumab at any time during pregnancy (exposed group)
- Exposure to other treatments for moderate/severe SLE if not exposed to anifrolumab (unexposed group)
You will not qualify if you...
- Pregnancy outcome occurred before first contact with the research center (retrospective enrollment)
- Exposure to known harmful drugs for pregnancy (teratogens) or investigational medications during pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Research Site
Wilmington, North Carolina, United States, 28401
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here