NIS to Examine Disease Activity in SLE Patients Treated With Subcutaneous Anifrolumab in Routine Care

NCT07424261 | Recruiting

• 1 other identifier: D3461R00100
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 6

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.

Conditions

Lupus Erythematosus, Systemic

Keywords

anifrolumab subcutaneous; real-world evidence; remission; fatigue; patient-reported quality of life

Outcome Measures

Primary Outcomes (1)

• 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

  At month 24

Secondary Outcomes (21)

• Proportion and number of patients in DORIS remission

  During routine visits up to 24 months

• Proportion and number of patients who ever achieved DORIS remission

  During routine visits up to 24 months

• Time (in months) to first DORIS remission among patients achieving DORIS criteria

  Baseline up to 24 months

• Time (in months) spent in DORIS remission among patients achieving DORIS criteria

  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

  Up to 24 months

Other Outcomes (1)

• Safety: Collection of Adverse Events (AE)

  Up to 24 months during routine visits

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (6)

Research Site

Bad Bramstedt, Germany

RECRUITING

Research Site

Berlin, Germany

RECRUITING

Research Site

Heidelberg, Germany

RECRUITING

Research Site

Kassel, Germany

RECRUITING

Research Site

München, Germany

RECRUITING

Research Site

Wuppertal, Germany

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Fatigue

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 20, 2026
• Study Start: March 19, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• 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

Locations

DE (6)