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The Anifrolumab PRIM Program

RECRUITINGSponsored by AstraZeneca
Actively Recruiting
SponsorAstraZeneca
Started2025-11-07
Est. completion2031-04-15
Eligibility
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06795893

Summary

Pregnancy and infant outcomes in anifrolumab exposed pregnancies using PRegnancy outcomes Intensive Monitoring (PRIM) data: The anifrolumab PRIM program

Eligibility

Sex: FEMALEHealthy volunteers accepted
Inclusion Criteria:

* 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

Exclusion Criteria:

* Pregnancy cases that have been enrolled in the prospective pregnancy registry (D3461R00051), those reported prior to the start of the PRIM program, or those that have been exposed to known teratogens or investigational medications will be excluded from the anifrolumab PRIM study.

Conditions2

LupusSystemic Lupus Erythematosus

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