Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 130 Years
Eligible Sex
Female
Accepts 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 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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Arm Groups

ArmDescriptionAssigned Intervention
Exposed cohort Pregnant individuals with a diagnosis of SLE who are exposed to anifrolumab at any time during pregnancy
Unexposed cohort Pregnant individuals with a diagnosis of moderate/severe SLE who are not exposed to anifrolumab at any time during pregnancy but who are exposed to other products for the treatment of SLE

Recruiting Locations

Research Site
Cary, North Carolina 27513

More Details

Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.