Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 11:37 PM
Study NCT ID:
NCT07424261
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-20
First Post:
2026-02-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NIS to Examine Disease Activity in SLE Patients Treated With Subcutaneous Anifrolumab in Routine Care
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
Effectiveness of Subcutaneous Anifrolumab in Systemic Lupus Erythematodes - A Non-interventional, Prospective, Multicenter Study on Disease Activity in SLE Patients Treated With Subcutaneous Anifrolumab in Routine Care
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIOLET
Brief 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.
Detailed Description:
This is a prospective, single-arm, multicenter, non-interventional study (NIS) to evaluate real-world clinical and patient-reported outcomes in adult patients with SLE who are initiated on anifrolumab SC therapy in line with the applicable european summary of product characteristics (SmPC) and neither having used anifrolumab SC or IV before.
This study aims to describe disease activity of SLE assessed by key treatment goals remission (DORIS) and lupus low disease activity (LLDAS), patient-reported quality of life, patterns of concomitant medication, and clinically relevant outcomes such as flares and organ damage in SLE patients treated with anifrolumab SC in a real-life setting. The 24-month observation period is chosen to capture long-term disease activity and disease control, and evaluate concomitant medication, and organ damage accrual in routine care.
This study aims to describe disease activity of SLE assessed by key treatment goals remission (DORIS) and lupus low disease activity (LLDAS), patient-reported quality of life, patterns of concomitant medication, and clinically relevant outcomes such as flares and organ damage in SLE patients treated with anifrolumab SC in a real-life setting. The 24-month observation period is chosen to capture long-term disease activity and disease control, and evaluate concomitant medication, and organ damage accrual in routine care.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: