A Non-Interventional Multi-Database Post-Authorisation Study to Assess Pregnancy-Related Safety Data From Women With SLE Exposed to Anifrolumab
AstraZeneca
Summary
This is a non-interventional multi-database post-authorisation study to assess pregnancy-related safety data from women with SLE exposed to Anifrolumab.
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.
Eligibility
- Age range
- 18–130 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion criteria for EXPOSED SOURCE POPULATION: * Women with a continuous enrolment in the database for ≥ 12 months prior to LMP2 * Women diagnosed with SLE before pregnancy * Women exposed to anifrolumab (polytherapy, added to SLE SOC) during pregnancy and/or 16-week period prior to LMP2 Exclusion criteria for EXPOSED SOURCE POPULATION: \- Pregnancies whose date of conception cannot be established Inclusion criteria for UNEXPOSED SOURCE POPULATION: * Women with a continuous enrolment in the database for ≥ 12 months prior to LMP2 * Women diagnosed with SLE before pregnancy * Women treat…
Location
- Research SiteCary, North Carolina