An observational study in Systemic Lupus Erythematosus, sponsored by AstraZeneca. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by AstraZeneca · Observational
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.
1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's planned enrollment of 500 is above the median of 140 across 283 observational studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
The population will encompass women with SLE of child-bearing potential age (15-49 years old) who start anifrolumab or other selected SLE treatments.
For the safety outcomes analyses the study population will include pregnant women and their infant born anytime during the study period.
Exclusion criteria for EXPOSED SOURCE POPULATION:
- Pregnancies whose date of conception cannot be established
Inclusion criteria for UNEXPOSED SOURCE POPULATION:
Exclusion criteria for UNEXPOSED SOURCE POPULATION:
Inclusion criteria for EXPOSED and UNEXPOSED STUDY POPULATION:
- Women with moderate/severe SLE
Exclusion criteria for EXPOSED and UNEXPOSED STUDY POPULATION:
Pregnant individuals with a diagnosis of SLE who are exposed to anifrolumab at any time during pregnancy
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
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
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
Time frame: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births
Risk of minor congenital malformations (mCM)
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
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 women who had moderate/severe SLE and were exposed or unexposed to anifrolumab during 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 adverse pregnancy outcomes
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
Time frame: At delivery/birth
Relative risk of adverse pregnancy outcomes
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
Time frame: At delivery/birth
Risk of adverse birth outcomes
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
Time frame: At delivery/birth
Relative risk of adverse birth outcomes
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
Time frame: At delivery/birth
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting information: Study protocol, Sap
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