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
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 design
Treatments tested in this trial
- Not listed
Trial groups
500 Participants
are grouped into 2 trial groupsSponsors and collaborators
AstraZeneca
Lead sponsor
IQVIA Pty Ltd
Collaborator
Source ClinicalTrials.gov