Actively Recruiting
The Anifrolumab PRIM Program
Led by AstraZeneca · Updated on 2026-04-27
240
Participants Needed
1
Research Sites
283 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
P
PPD Development, LP
Collaborating Sponsor
AI-Summary
What this Trial Is About
Pregnancy and infant outcomes in anifrolumab exposed pregnancies using PRegnancy outcomes Intensive Monitoring (PRIM) data: The anifrolumab PRIM program
CONDITIONS
Official Title
The Anifrolumab PRIM Program
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Currently or recently (within 1 year of pregnancy outcome) pregnant
- Exposure to at least 1 dose of anifrolumab at any time during pregnancy or in the 16 weeks prior to date of conception
You will not qualify if you...
- Pregnancy cases enrolled in the prospective pregnancy registry (D3461R00051)
- Pregnancy cases reported before the start of the PRIM program
- Exposure to known teratogens during pregnancy
- Exposure to 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
Reseach Facility
Södertälje, Sweden
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
1
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