clinical trial · NCT07049653
Anifrolumab Pregnancy Study
AstraZeneca·—·not yet recruiting·n = 627
Systemic Lupus Erythematosus
brief summary
This is a non-interventional multi-database post-authorisation study to assess pregnancy-related safety data from women with SLE exposed to Anifrolumab.
started
Jan 31, 2026
primary completion
Dec 10, 2030
completion
Dec 10, 2030
last updated
Aug 15, 2025
detailed description
The aim of this study is to describe congenital malformations, adverse pregnancy and birth outcomes in pregnancies/offspring from women with moderate/severe SLE exposed to anifrolumab during pregnancy and to compare with outcomes in women with moderate/severe SLE who are exposed to other standard of care but not anifrolumab. Adverse outcomes related to infant growth up to one year of age will also be investigated.
official title
A Non-Interventional Multi-Database Post-Authorisation Study to Assess Pregnancy-Related Safety Data From Women With SLE Exposed to Anifrolumab
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol