Clinical Trial

Anifrolumab Pregnancy Study

Study acronym: ROSE
Recruiting
View on ClinicalTrials.gov →
Summary
This is a non-interventional multi-database post-authorisation study to assess pregnancy-related safety data from women with SLE exposed to Anifrolumab.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-06-25; most recent amendment 2026-07-07.
Status change: Not Yet Recruiting → Recruiting 2026-06-23
Trial Details
NCT Number NCT07049653
Lead Sponsor AstraZeneca
Collaborators: IQVIA Pty Ltd
Conditions Systemic Lupus Erythematosus
Enrollment 500 participants
Start Date 2026-06-04
Primary Completion 2030-12-10 (estimated)
Study Completion 2030-12-10 (estimated)
Updated on ClinicalTrials.gov 2026-07-08