Anifrolumab Pregnancy Study - ROSE
Study identifier:D3461R00028
ClinicalTrials.gov identifier:NCT07049653
EudraCT identifier:N/A
CTIS identifier:N/A
Will Be Recruiting
Official Title
A Non-Interventional Multi-Database Post-Authorisation Study to Assess Pregnancy-Related Safety Data from Women with SLE Exposed to Anifrolumab
Medical condition
Systemic Lupus Erythematosus
Phase
N/A
Healthy volunteers
No
Study drug
-
Sex
Female
Estimated Enrollment
627
Study type
Observational
Age
18 Years - 130 Years
Date
Study Start Date: 31 Jan 2026
Estimated Primary Completion Date: 10 Dec 2030
Estimated Study Completion Date: 10 Dec 2030
Study design
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verification:
Verified 01 Aug 2025 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
IQVIA
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| 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 | - |
