Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07049653

Anifrolumab Pregnancy Study

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year–130 year

Sex eligibility

Female

Study type

Observational

Primary location

Research Site

Cary, North Carolina, 27513, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Risk of major congenital malformations (MCM)

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

    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

  2. Relative risk of MCM

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

    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

  3. Risk of select pregnancy loss outcomes

    Time frame: At delivery/birth

    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

  4. Relative risk of select pregnancy loss outcomes

    Time frame: At delivery/birth

    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

Secondary outcomes

  1. Demographic and clinical characteristics

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

    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

  2. Risk of minor congenital malformations (mCM)

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

    Describe and estimate the risk of mCM in live and non-live offspring from women with moderate/severe SLE who were exposed or unexposed to anifrolumab during pregnancy

  3. Relative risk of mCM

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

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

  4. Risk of adverse pregnancy outcomes

    Time frame: At delivery/birth

    Describe and estimate the risk of adverse pregnancy outcomes (ectopic pregnancy, spontaneous abortion, elective termination of pregnancy, stillbirth, infections requiring hospitalisation during pregnancy, emergency caesarean section) in all pregnancies from women who had moderate/severe SLE and were exposed or unexposed to anifrolumab during pregnancy

  5. Relative risk of adverse pregnancy outcomes

    Time frame: At delivery/birth

    Estimate the relative risk of adverse pregnancy outcomes (ectopic pregnancy, spontaneous abortion, elective termination of pregnancy, stillbirth, infections requiring hospitalisation during pregnancy, emergency caesarean section) in pregnancies from women who had moderate/severe SLE and were exposed or unexposed to anifrolumab during pregnancy

  6. Risk of adverse birth outcomes

    Time frame: At delivery/birth

    Describe and estimate the risk of adverse birth outcomes (preterm birth,

    small for gestational age (SGA)) in live offspring from women who had moderate/severe SLE and were exposed or unexposed to anifrolumab during pregnancy

  7. Relative risk of adverse birth outcomes

    Time frame: At delivery/birth

    Estimate the relative risk of adverse birth outcomes (preterm birth, small for gestational age (SGA)) in live offspring from women who had moderate/severe SLE and were exposed or unexposed to anifrolumab during pregnancy

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • IQVIA Pty Ltd

Registry information

Official study title

A Non-Interventional Multi-Database Post-Authorisation Study to Assess Pregnancy-Related Safety Data From Women With SLE Exposed to Anifrolumab

Acronym: ROSE

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jul 3, 2025
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.