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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-13', 'studyFirstSubmitDate': '2026-02-13', 'studyFirstSubmitQcDate': '2026-02-13', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety: Collection of Adverse Events (AE)', 'timeFrame': 'Up to 24 months during routine visits', 'description': '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'}], 'primaryOutcomes': [{'measure': 'Proportion and number of patients who fulfill criteria for definition of remission in SLE (DORIS remission)', 'timeFrame': 'At month 24', 'description': 'To assess disease activity at month 24 by evaluating the attainment of DORIS remission following initiation of anifrolumab SC treatment'}], 'secondaryOutcomes': [{'measure': 'Proportion and number of patients in DORIS remission', 'timeFrame': 'During routine visits up to 24 months', 'description': 'To describe the course of DORIS remission in patients initiating treatment with anifrolumab SC'}, {'measure': 'Proportion and number of patients who ever achieved DORIS remission', 'timeFrame': 'During routine visits up to 24 months', 'description': 'To describe the course of DORIS remission in patients initiating treatment with anifrolumab SC'}, {'measure': 'Time (in months) to first DORIS remission among patients achieving DORIS criteria', 'timeFrame': 'Baseline up to 24 months', 'description': 'To describe the course of DORIS remission in patients initiating treatment with anifrolumab SC'}, {'measure': 'Time (in months) spent in DORIS remission among patients achieving DORIS criteria', 'timeFrame': 'Up to 24 months', 'description': 'To describe the course of DORIS remission in patients initiating treatment with anifrolumab SC'}, {'measure': 'Time (in months) spent in sustained DORIS remission if in remission for at least 2 consecutive routine visits among patients achieving DORIS criteria', 'timeFrame': 'Up to 24 months', 'description': 'To describe the course of DORIS remission in patients initiating treatment with anifrolumab SC'}, {'measure': 'Proportion and number of patients attaining sustained DORIS remission among patients achieving DORIS criteria', 'timeFrame': 'At month 6 and month 12', 'description': 'To describe the course of DORIS remission in patients initiating treatment with anifrolumab SC'}, {'measure': 'Proportion and number of patients who fulfill criteria of lupus low disease activity state (LLDAS)', 'timeFrame': 'At month 24', 'description': 'To describe the course of LLDAS in patients initiating treatment with anifrolumab SC'}, {'measure': 'Proportion and number of patients ever achieving LLDAS criteria', 'timeFrame': 'During routine visits up to 24 months', 'description': 'To describe the course of LLDAS in patients initiating treatment with anifrolumab SC'}, {'measure': 'Time (in months) to first achieving LLDAS criteria among patients achieving LLDAS criteria', 'timeFrame': 'Up to 24 months', 'description': 'To describe the course of LLDAS in patients initiating treatment with anifrolumab SC'}, {'measure': 'Time (in months) spent in LLDAS among patients achieving LLDAS criteria', 'timeFrame': 'Up to 24 months', 'description': 'To describe the course of LLDAS in patients initiating treatment with anifrolumab SC'}, {'measure': 'Time (in months) spent in sustained LLDAS if in LLDAS for at least 2 consecutive routine visits among patients achieving LLDAS criteria', 'timeFrame': 'Up to 24 months', 'description': 'To describe the course of LLDAS in patients initiating treatment with anifrolumab SC'}, {'measure': 'Proportion and number of patients attaining sustained LLDAS', 'timeFrame': 'At month 6 and month 12', 'description': 'To describe the course of LLDAS in patients initiating treatment with anifrolumab SC'}, {'measure': 'Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2k)', 'timeFrame': 'From Baseline to every routine visit up to 24 months during routine visits', 'description': 'To describe the course of disease activity as captured by SLEDAI-2K in patients initiating treatment with anifrolumab SC.\n\nThe 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.'}, {'measure': 'Change in Systemic Lupus Erythematosus Disease Activity Score (SLE-DAS)', 'timeFrame': 'From Baseline to every routine visit up to 24 months during routine visits', 'description': 'To describe the course of disease activity as captured by SLE-DAS in patients initiating treatment with anifrolumab SC.\n\nThe 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.'}, {'measure': 'Change in Physician Global Assessment (PhGA) analog scale (0-3)', 'timeFrame': 'From Baseline to every routine visit up to 24 months during routine visits', 'description': "To describe the course of disease activity as captured by PhGA in patients initiating treatment with anifrolumab SC.\n\nPhGA 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)."}, {'measure': 'Change in Systemic Lupus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index (SDI) score', 'timeFrame': 'Baseline up to month 24', 'description': '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.'}, {'measure': 'SLE treatment patterns prior to, concomitant with and after anifrolumab', 'timeFrame': 'From Baseline (1 year pre-anifrolumab) up to 24 months', 'description': 'To characterize SLE medication patterns in patients initiating treatment with anifrolumab SC'}, {'measure': 'Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue)', 'timeFrame': 'Baseline up to 24 months', 'description': '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).'}, {'measure': 'Patient Global Assessment (PtGA)', 'timeFrame': 'Baseline up to 24 months', 'description': '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)'}, {'measure': 'Lupus Quality of Life (LupusQoL)', 'timeFrame': 'Baseline up to 24 months', 'description': '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.'}, {'measure': 'SLE Flares assessment by modified revised Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) flare index (rSFI)', 'timeFrame': 'Baseline up to 24 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anifrolumab subcutaneous', 'real-world evidence', 'remission', 'fatigue', 'patient-reported quality of life'], 'conditions': ['Lupus Erythematosus, Systemic']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '130 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "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.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥18 years at the time of signing the informed consent\n* Diagnosis of SLE\n* Prescription of anifrolumab SC in line with the european summary of product characteristics (SmPC)\n* Prescription of anifrolumab SC was decided prior to and independently of the study\n* Signed and dated written informed consent prior to enrolment into the study\n* Willing and able to participate in all study evaluations and procedures\n\nExclusion Criteria:\n\n* Prior exposure to anifrolumab\n* Treatment with concurrent biologics\n* Current or planned participation in a clinical study that does not constitute routine care\n* 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\n* 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)\n* Pregnancy or breast feeding at study enrolment"}, 'identificationModule': {'nctId': 'NCT07424261', 'acronym': 'VIOLET', 'briefTitle': 'NIS to Examine Disease Activity in SLE Patients Treated With Subcutaneous Anifrolumab in Routine Care', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'D3461R00100'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'AstraZeneca Clinical Study Information Center', 'role': 'CONTACT', 'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'timeFrame': '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', 'ipdSharing': 'YES', 'description': '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.', 'accessCriteria': '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'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}