What is this study trying to find out about systemic lupus erythematosus (SLE)?

This study aims to observe how adults with SLE respond to subcutaneous anifrolumab treatment in real-world routine care. Researchers want to understand disease activity, remission rates, quality of life, medication use, and long-term outcomes over two years. The study is sponsored by AstraZeneca and focuses on patients new to anifrolumab therapy.

Who may be eligible for this systemic lupus erythematosus clinical trial?

Adults aged 18 to 130 years diagnosed with SLE who are starting subcutaneous anifrolumab treatment for the first time may be eligible. Both men and women can participate, but pregnant or breastfeeding individuals are excluded. Participants must be willing and able to complete study evaluations over 24 months. Please review eligibility criteria for more details.

Is there any cost to participate in this systemic lupus erythematosus clinical trial?

Study-related care, including the medication and all study visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or related costs.

Actively Recruiting

Age: 18Years - 130Years

All Genders

ID07424261

Effectiveness of Subcutaneous Anifrolumab in Systemic Lupus Erythematosus A Non-interventional, Prospective, Multicenter Study on Disease Activity in SLE Patients Treated With Subcutaneous Anifrolumab in Routine Care

Led by AstraZeneca · Updated on 2026-05-12

125

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating real-world clinical and patient-reported outcomes in adults with systemic lupus erythematosus SLE who start treatment with subcutaneous anifrolumab. This non-interventional, multicenter study aims to observe disease activity, treatment goals like remission and low disease activity, quality of life, medication use, flares, and organ damage over two years. The study follows patients who have not previously used anifrolumab either subcutaneously or intravenously. Participants receive anifrolumab via subcutaneous injections as prescribed according to the European summary of product characteristics. This study is single-arm and non-interventional, meaning treatment decisions are made independently by doctors and not assigned by the study. The observation period lasts 24 months to capture long-term disease control, medication patterns, and organ damage development during routine care. During the study, patients will be regularly assessed for disease activity using tools such as the DORIS remission criteria and lupus low disease activity state LLDAS. Researchers will also evaluate patient-reported outcomes like quality of life and fatigue, and record changes in disease activity scores and damage indices. Data on treatment patterns and flare events will be collected throughout the 24 months, with safety and health monitored as part of routine visits.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 130Years

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years or older at the time of signing the informed consent
Diagnosis of systemic lupus erythematosus (SLE)
Prescription of subcutaneous anifrolumab according to European summary of product characteristics
Decision to use subcutaneous anifrolumab made before and independently of the study
Signed and dated informed consent before enrollment
Willing and able to participate in all study evaluations and procedures

You will not qualify if you...

Prior use of anifrolumab
Treatment with other biologic therapies concurrently
Current or planned participation in a clinical study outside routine care
Severe or rapidly progressive Class III or IV glomerulonephritis requiring induction therapy
Isolated Class V lupus nephritis without other SLE symptoms
Active severe or unstable neuropsychiatric lupus
Conditions limiting ability to complete questionnaires or participate over 24 months (e.g., significant cognitive impairment, severe psychiatric illness, uncontrolled substance use)
Pregnancy or breastfeeding at study enrollment

Research Team

AstraZeneca Clinical Study Information Center

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