Clinical Trial

NIS to Examine Disease Activity in SLE Patients Treated With Subcutaneous Anifrolumab in Routine Care

Study acronym: VIOLET
Recruiting
View on ClinicalTrials.gov →
Summary
VIOLET is a prospective, single-arm, multi-centre, non-interventional study (NIS) evaluating real-world clinical and patient-reported outcome (PRO) data in adult patients who are initiated on subcutaneous anifrolumab treatment of systemic lupus erythematosus (SLE) in line with the applicable european summary of product characteristics (SmPC) and neither having used anifrolumab subcutaneous (SC) or intravenous (IV) before.
Protocol Amendment History 3 changes
notable Trial sites expanded: 6 -> 16 locations 2026-05-13
critical Recruitment opened 2026-04-14
notable Trial sites expanded: 0 -> 6 locations 2026-04-14
Trial Details
NCT Number NCT07424261
Lead Sponsor AstraZeneca
Conditions Lupus Erythematosus, Systemic
Enrollment 125 participants
Start Date 2026-03-19
Primary Completion 2029-08-31 (estimated)
Study Completion 2029-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-24