An observational study in Lupus Erythematosus, Systemic, sponsored by AstraZeneca. Recruiting at 21 sites in Germany. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by AstraZeneca · Observational
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.
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.
1,207 studies on the registry are indexed under Lupus Erythematosus, Systemic; 405 are open to participants now.
This study's planned enrollment of 125 is below the median of 151 across 280 observational studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
125 patients ≥18 years of age, who have been diagnosed with systemic lupus erythematosus (SLE) and who are initiated on subcutaneous (SC) anifrolumab therapy independently of the study and in line with the applicable european summary of product characteristics (SmPC) within routine clinical practice neither having used subcutaneous nor intravenous (IV) anifrolumab before will be enrolled. Patients must be willing and able to report PROs. Eligible patients will be enrolled into the study after the after the treating physicians' diagnostic and therapeutic decisions.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Proportion and number of patients who fulfill criteria for definition of remission in SLE (DORIS remission)
To assess disease activity at month 24 by evaluating the attainment of DORIS remission following initiation of anifrolumab SC treatment
Time frame: At month 24
Proportion and number of patients in DORIS remission
To describe the course of DORIS remission in patients initiating treatment with anifrolumab SC
Time frame: During routine visits up to 24 months
Proportion and number of patients who ever achieved DORIS remission
To describe the course of DORIS remission in patients initiating treatment with anifrolumab SC
Time frame: During routine visits up to 24 months
Time (in months) to first DORIS remission among patients achieving DORIS criteria
To describe the course of DORIS remission in patients initiating treatment with anifrolumab SC
Time frame: Baseline up to 24 months
Time (in months) spent in DORIS remission among patients achieving DORIS criteria
To describe the course of DORIS remission in patients initiating treatment with anifrolumab SC
Time frame: Up to 24 months
Time (in months) spent in sustained DORIS remission if in remission for at least 2 consecutive routine visits among patients achieving DORIS criteria
To describe the course of DORIS remission in patients initiating treatment with anifrolumab SC
Time frame: Up to 24 months
Proportion and number of patients attaining sustained DORIS remission among patients achieving DORIS criteria
To describe the course of DORIS remission in patients initiating treatment with anifrolumab SC
Time frame: At month 6 and month 12
Proportion and number of patients who fulfill criteria of lupus low disease activity state (LLDAS)
To describe the course of LLDAS in patients initiating treatment with anifrolumab SC
Time frame: At month 24
Proportion and number of patients ever achieving LLDAS criteria
To describe the course of LLDAS in patients initiating treatment with anifrolumab SC
Time frame: During routine visits up to 24 months
Time (in months) to first achieving LLDAS criteria among patients achieving LLDAS criteria
To describe the course of LLDAS in patients initiating treatment with anifrolumab SC
Time frame: Up to 24 months
Time (in months) spent in LLDAS among patients achieving LLDAS criteria
To describe the course of LLDAS in patients initiating treatment with anifrolumab SC
Time frame: Up to 24 months
Time (in months) spent in sustained LLDAS if in LLDAS for at least 2 consecutive routine visits among patients achieving LLDAS criteria
To describe the course of LLDAS in patients initiating treatment with anifrolumab SC
Time frame: Up to 24 months
Proportion and number of patients attaining sustained LLDAS
To describe the course of LLDAS in patients initiating treatment with anifrolumab SC
Time frame: At month 6 and month 12
Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2k)
To describe the course of disease activity as captured by SLEDAI-2K in patients initiating treatment with anifrolumab SC. The SLEDAI-2K is a global index and includes 24 clinical symptoms and laboratory variables that are weighted by the type of manifestation, but not by severity or dynamic of the individual item. The SLEDAI-2K includes scoring for antibodies and low complement, as well as some renal and hematologic parameters. The total score ranges between 0 and 105, with higher scores representing increased disease activity.
Time frame: From Baseline to every routine visit up to 24 months during routine visits
Change in Systemic Lupus Erythematosus Disease Activity Score (SLE-DAS)
To describe the course of disease activity as captured by SLE-DAS in patients initiating treatment with anifrolumab SC. The Systemic Lupus Erythematosus Disease Activity Score (SLE-DAS) is a validated and reliable composite index that includes 17 clinical and laboratory variables capturing a broad spectrum of SLE manifestations across multiple organ systems. The SLE-DAS will use a 30-day reference window, yielding a continuous score, with higher values indicating greater disease activity.
Time frame: From Baseline to every routine visit up to 24 months during routine visits
Change in Physician Global Assessment (PhGA) analog scale (0-3)
To describe the course of disease activity as captured by PhGA in patients initiating treatment with anifrolumab SC. PhGA is a single-item visual analogue scale that describes the physician assessment of a patient's disease and its impact on daily functioning at the time of assessment. The scale ranges from 0 (asymptomatic disease and no limitation of normal activities) to 3 (severe disease and limitation of normal activities).
Time frame: From Baseline to every routine visit up to 24 months during routine visits
Change in Systemic Lupus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index (SDI) score
To describe organ involvement captured by SLICC damage index (SDI) in patients initiating treatment with anifrolumab SC. The Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index will be used to measure irreversible, accumulated organ damage from either the disease process or disease treatment, which has been present for at least 6 months, in 12 organ systems.
Time frame: Baseline up to month 24
SLE treatment patterns prior to, concomitant with and after anifrolumab
To characterize SLE medication patterns in patients initiating treatment with anifrolumab SC
Time frame: From Baseline (1 year pre-anifrolumab) up to 24 months
Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue)
To describe the course of patient-reported fatigue. The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses patient-reported fatigue and its impact upon daily activities and function over the past 7 days. Patients will be asked to answer each question using a 5-point verbal rating scale, with total scores ranging from 0 (most fatigued) to 52 (least fatigued).
Time frame: Baseline up to 24 months
Patient Global Assessment (PtGA)
To describe the course of overall patient-reported quality of life. The PtGA is a single-item question that takes into account all the ways in which illness and health conditions may affect the patient at this time. The patient should consider the previous week when answering this question. Responses range from 0 (Very Well) to 100 (Very Poorly) on a visual analogue scale (VAS)
Time frame: Baseline up to 24 months
Lupus Quality of Life (LupusQoL)
To describe the course of patient-reported SLE-specific quality of life. The LupusQoL is a validated SLE-specific HRQoL (health-related quality of life) instrument consisting of 34 items across 8 domains (Physical health, Emotional health, Body image, Pain, Planning, Fatigue, Intimate relationships, and Burden to others). The LupusQoL has a 5-point verbal rating scale, and uses a 4-week recall period. The mean raw domain score is transformed to scores ranging from 25 (worst HRQoL) to 125 (best HRQoL) by dividing by 4 and then multiplying by 100.
Time frame: Baseline up to 24 months
SLE Flares assessment by modified revised Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) flare index (rSFI)
To describe frequency and intensity of flares within the observational period. The frequency and intensity of flares will be documented using the modified revised SELENA-SLEDAI Flare Index (rSFI), which detects flares and classifies severity based on changes in SLEDAI-2K. Flare will be defined as any one criterion present either the Mild/Moderate Flare or Severe Flare categories. Flares experienced by the patients since enrolment will be collected at subsequent routine visit by the physician.
Time frame: Baseline up to 24 months
Safety: Collection of Adverse Events (AE)
To describe the safety and tolerability of anifrolumab SC treatment. Safety evaluated based on type of Adverse Event (AE), intensity, causal relationship to treatment, duration, handling, outcome, and seriousness
Time frame: Up to 24 months during routine visits
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Access criteria: When a request has been approved, AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Aug 2029, 41 months after the start.
Of 110 observational studies under Lupus Erythematosus, Systemic, half reached primary completion within 64 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 126. This study's planned 41 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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