Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07424261
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.
Study:
NCT07424261
Study Brief:
Protocol Section:
NCT07424261