Health TrialsbyHealthPanel

Anifrolumab Pregnancy Study

ConditionSystemic Lupus Erythematosus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-130
SponsorAstraZeneca

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Women treated with anifrolumab during pregnancy and/or 16-week period prior to LMP2

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

500 Participants
are grouped into 2 trial groups
Group A: Exposed cohort
Group B: Unexposed cohort

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

IQVIA Pty Ltd

Collaborator

Source ClinicalTrials.gov
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