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Anifrolumab Pregnancy Study
RecruitingObservational study
A Non-Interventional Multi-Database Post-Authorisation Study to Assess Pregnancy-Related Safety Data From Women With SLE Exposed to Anifrolumab
Who can join
Ages 18 to 130 · Women
Full 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
About the study
This is a non-interventional multi-database post-authorisation study to assess pregnancy-related safety data from women with SLE exposed to Anifrolumab.
Sponsor: AstraZeneca · Participants: 500 · Started: Jun 4, 2026
Contact the study team
- AstraZeneca Clinical Study Information Center · Phone: 1-877-240-9479
Official record on ClinicalTrials.gov — NCT07049653
Locations in the U.S.
| North Carolina | Research Site, Cary |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.