A Non-Interventional Multi-Database Post-Authorisation Study to Assess Pregnancy-Related Safety Data From Women With SLE Exposed to Anifrolumab
Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY
This is a non-interventional multi-database post-authorisation study to assess pregnancy-related safety data from women with SLE exposed to Anifrolumab.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 130
Healthy Volunteers: f
View:
• 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
• 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 with moderate/severe SLE
Locations
United States
North Carolina
Research Site
RECRUITING
Cary
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2026-06-04
Estimated Completion Date: 2030-12-10
Participants
Target number of participants: 500
Treatments
Exposed cohort
Pregnant individuals with a diagnosis of SLE who are exposed to anifrolumab at any time during pregnancy
Unexposed cohort
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
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca
Collaborators: IQVIA Pty Ltd