Lupus Erythematosus, SystemicVIOLETNCT07424261
NIS to Examine Disease Activity in SLE Patients Treated With Subcutaneous Anifrolumab in Routine Care
An observational study of Lupus Erythematosus, Systemic, run by AstraZeneca at 21 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Lupus Erythematosus, Systemic
- How many people
- 125 participants
- Where
- 21 sitesGermany
- Study dates
- 19 Mar 2026to 31 Aug 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age ≥18 years at the time of signing the informed consent
- Diagnosis of SLE
- Prescription of anifrolumab SC in line with the european summary of product characteristics (SmPC)
- Prescription of anifrolumab SC was decided prior to and independently of the study
- Signed and dated written informed consent prior to enrolment into the study
- Willing and able to participate in all study evaluations and procedures
Who cannot join
- Prior exposure to anifrolumab
- Treatment with concurrent biologics
- Current or planned participation in a clinical study that does not constitute routine care
- Currently experiencing a severe or rapidly progressive Class III or IV glomerulonephritis requiring induction therapy (mycophenolate mofetil [MMF]/cyclophosphamide + high dose steroids), isolated Class V lupus nephritis (in absence of other SLE manifestations, i.e. skin/joint involvement), or active severe or unstable neuropsychiatric lupus
- Conditions (acute or chronic) or events at the time of signing the informed consent that would limit the patient's ability to complete questionnaires or participate in this study over the period of 24 months according to the treating physician (e.g., clinically significant cognitive impairment or dementia, unstable severe psychiatric illness, uncontrolled alcohol or substance use disorder that interferes with adherence to care or other circumstances that preclude completing PROs or attending routine visits)
- Pregnancy or breast feeding at study enrolment
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
21 sites in 1 country
Germany21 sites, 21 recruiting
- Recruiting
Research Site
Altenburg
- Recruiting
Research Site
Bad Bramstedt
- Recruiting
Research Site
Bamberg
- Recruiting
Research Site
Berlin
- Recruiting
Research Site
Braunschweig
- Recruiting
Research Site
Chemnitz
- Recruiting
Research Site
Erlangen
- Recruiting
Research Site
Hanover
- Recruiting
Research Site
Heidelberg
- Recruiting
Research Site
Herne
- Recruiting
Research Site
Kassel
- Recruiting
Research Site
Leipzig
- Recruiting
Research Site
Meerbusch-Lank
- Recruiting
Research Site
München
- Recruiting
Research Site
Neunkirchen
- Recruiting
Research Site
Planegg
- Recruiting
Research Site
Schwerin
- Recruiting
Research Site
Trier
- Recruiting
Research Site
Wetzlar
- Recruiting
Research Site
Wuppertal
- Recruiting
Research Site
Würzburg
About this study
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
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.
Read the 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.
- Conditions
- Lupus Erythematosus, Systemic
- Keywords
- anifrolumab subcutaneous, real-world evidence, remission, fatigue, patient-reported quality of life
- Medical subject headings
- Lupus Erythematosus, Systemic, Fatigue
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At month 24
Secondary outcomes (21)
Proportion and number of patients in DORIS remission
To describe the course of DORIS remission in patients initiating treatment with anifrolumab SC
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Baseline up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start19 Mar 2026
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424261
- Sponsor's protocol ID
- D3461R00100
- Acronym
- VIOLET
- Status last verified
- Oct 2026
- First submitted
- 13 Feb 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07424261
- Acronym / sponsor ID
- VIOLET / D3461R00100
- Conditions
- Lupus Erythematosus, Systemic
- Keywords
- anifrolumab subcutaneous, real-world evidence, remission, fatigue, patient-reported quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- Age ≥18 years at the time of signing the informed consent
- Diagnosis of SLE
- Prescription of anifrolumab SC in line with the european summary of product characteristics (SmPC)
- Prescription of anifrolumab SC was decided prior to and independently of the study
- Signed and dated written informed consent prior to enrolment into the study
Key exclusion criteria (6 listed)
- Prior exposure to anifrolumab
- Treatment with concurrent biologics
- Current or planned participation in a clinical study that does not constitute routine care
- Currently experiencing a severe or rapidly progressive Class III or IV glomerulonephritis requiring induction therapy (mycophenolate mofetil [MMF]/cyclophosphamide + high dose steroids), isolated Class V lupus nephritis (in absence of other SLE manifestations, i.e. skin/joint involvement), or active severe or unstable neuropsychiatric lupus
- Conditions (acute or chronic) or events at the time of signing the informed consent that would limit the patient's ability to complete questionnaires or participate in this study over the period of 24 months according to the treating physician (e.g., clinically significant cognitive impairment or dementia, unstable severe psychiatric illness, uncontrolled alcohol or substance use disorder that interferes with adherence to care or other circumstances that preclude completing PROs or attending routine visits)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion and number of patients who fulfill criteria for definition of remission in SLE (DORIS remission)
Time frame: At month 24
To assess disease activity at month 24 by evaluating the attainment of DORIS remission following initiation of anifrolumab SC treatment
21 secondary outcomes
Proportion and number of patients in DORIS remission
Time frame: During routine visits up to 24 months
Proportion and number of patients who ever achieved DORIS remission
Time frame: During routine visits up to 24 months
Time (in months) to first DORIS remission among patients achieving DORIS criteria
Time frame: Baseline up to 24 months
Time (in months) spent in DORIS remission among patients achieving DORIS criteria
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
Time frame: Up to 24 months
Proportion and number of patients attaining sustained DORIS remission among patients achieving DORIS criteria
Time frame: At month 6 and month 12
Proportion and number of patients who fulfill criteria of lupus low disease activity state (LLDAS)
Time frame: At month 24
Proportion and number of patients ever achieving LLDAS criteria
Time frame: During routine visits up to 24 months
Time (in months) to first achieving LLDAS criteria among patients achieving LLDAS criteria
Time frame: Up to 24 months
Time (in months) spent in LLDAS among patients achieving LLDAS criteria
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
Time frame: Up to 24 months
Proportion and number of patients attaining sustained LLDAS
Time frame: At month 6 and month 12
Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2k)
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)
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)
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
Time frame: Baseline up to month 24
SLE treatment patterns prior to, concomitant with and after anifrolumab
Time frame: From Baseline (1 year pre-anifrolumab) up to 24 months
Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue)
Time frame: Baseline up to 24 months
Patient Global Assessment (PtGA)
Time frame: Baseline up to 24 months
Lupus Quality of Life (LupusQoL)
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)
Time frame: Baseline up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Erythematosus, Systemic, run by AstraZeneca at 21 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion and number of patients who fulfill criteria for definition of remission in SLE (DORIS remission) (time frame: At month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.