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Anifrolumab Pregnancy Study

RecruitingN/A

Sponsor: AstraZeneca

Conditions: Systemic Lupus Erythematosus

Countries: United States

This is a non-interventional multi-database post-authorisation study to assess pregnancy-related safety data from women with SLE exposed to Anifrolumab.

Eligibility overview

Sex: FEMALE

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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 treated with SLE SOC during pregnancy

Exclusion criteria for UNEXPOSED SOURCE POPULATION:

* Women treated with anifrolumab during pregnancy and/or 16-week period prior to LMP2
* Pregnancies whose date of conception cannot be established

Inclusion criteria for EXPOSED and UNEXPOSED STUDY POPULATION:

\- Women with moderate/severe SLE

Exclusion criteria for EXPOSED and UNEXPOSED STUDY POPULATION:

* Women with a history of CM or chromosomal abnormalities (according to available records), before delivery
* Women prescribed a confirmed teratogenic drug prior to LMP2 with a time period of 5-half-lives of relevant drug or during pregnancy

Locations (1)

Cary, North Carolina, United States