Anifrolumab Pregnancy Study

AstraZeneca500 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Systemic Lupus Erythematosus

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 130 Years

Medical Language ↔ Plain English

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)

Research Site

Cary, North Carolina, United States

RECRUITING

Outcomes

Primary Outcomes

Risk of major congenital malformations (MCM)

Describe and estimate the risk of MCM in live and non-live offspring from the women who had moderate/severe SLE and were exposed to anifrolumab during the first trimester of pregnancy or exposed to SOC and unexposed to anifrolumab during the first trimester of pregnancy

Time frame: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births

Relative risk of MCM

Estimate the relative risk of MCM in live and non-live offspring from the women who had moderate/severe SLE and were exposed to anifrolumab during the first trimester of pregnancy or exposed to SOC and unexposed to anifrolumab during the first trimester of pregnancy

Time frame: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births

Risk of select pregnancy loss outcomes

Describe and estimate the risk of select pregnancy loss outcomes (composite of spontaneous abortion and stillbirth) in all pregnancies from women who had moderate/severe SLE and were exposed or unexposed to anifrolumab during pregnancy

Time frame: At delivery/birth

Relative risk of select pregnancy loss outcomes

Estimate the relative risk of select pregnancy loss outcomes (composite of spontaneous abortion and stillbirth) in pregnancies from women who had moderate/severe SLE and were exposed or unexposed to anifrolumab during pregnancy

Time frame: At delivery/birth

Secondary Outcomes

Demographic and clinical characteristics

Describe the demographic and clinical characteristics of the live and non-live offspring and their mothers who had moderate/severe SLE and were exposed or unexposed to anifrolumab during the first trimester of pregnancy or anytime during pregnancy

Central Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479 information.center@astrazeneca.com

Data from ClinicalTrials.gov

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