Clinical Trial

Anifrolumab Malignancy and Serious Infections Study

Study acronym: SIMA
Recruiting
View on ClinicalTrials.gov →
Summary
This is an observational study, in which the main research question is to evaluate the risk of malignancies and serious infections among moderate/severe SLE patients who receive anifrolumab compared with a comparable population of moderate/severe SLE patients on standard of care who do not initiate anifrolumab.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2025-05-23; most recent amendment 2026-06-18.
Status change: Not Yet Recruiting → Recruiting 2026-02-18
Trial Details
NCT Number NCT07000110
Lead Sponsor AstraZeneca
Collaborators: IQVIA Pty Ltd
Conditions Systemic Lupus Erythematosus
Enrollment 3,506 participants
Start Date 2026-01-26
Primary Completion 2031-11-30 (estimated)
Study Completion 2031-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-13