Anifrolumab Pregnancy Study (ROSE)

AstraZeneca

Status: Not yet enrolling

Conditions: Systemic Lupus Erythematosus

Study type: Observational

Funder types: Industry

Identifiers

NCT07049653

D3461R00028

Details and patient eligibility

About

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

Full 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.

Enrollment: 627 estimated patients

Sex: Female

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

627 participants in 2 patient groups

Exposed cohort

Description:

Pregnant individuals with a diagnosis of SLE who are exposed to anifrolumab at any time during pregnancy

Unexposed cohort

Description:

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