RecruitingOBSERVATIONAL

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

This study, called VIOLET, is for adults with a condition called lupus (Systemic Lupus Erythematosus or SLE). We're looking at people who are starting treatment with a new medicine called anifrolumab, given by injection under the skin. This isn't a typical drug trial where people get different treatments; instead, we're watching how anifrolumab works in patients' everyday lives. We'll be checking how well it controls their lupus symptoms, how it affects their quality of life, and if there are any changes in their other medicines or overall health over a two-year period. The goal is to understand the long-term effects of anifrolumab in real patients.

At a glance

Status

Recruiting

Sponsor

AstraZeneca

Enrolment target

125

Start

19 Mar 2026

Estimated completion

31 Aug 2029

Lupus Erythematosus, Systemic

What is this study about?

This study, called VIOLET, is all about understanding how a medicine called anifrolumab works for people with Systemic Lupus Erythematosus (SLE), often just called lupus. Lupus is a long-term condition that can affect many parts of the body, causing symptoms like joint pain, skin rashes, and tiredness. Anifrolumab is a treatment for lupus that you inject yourself under the skin, and this study looks at how it works for patients in their daily lives, outside of a strict clinical trial setting.

Researchers want to see if anifrolumab helps to get lupus under control, focusing on things like reducing disease activity and improving a patient's overall quality of life. They will also keep an eye on other important things, such as whether patients need to take other lupus medicines less often, if their lupus symptoms get better, or if the condition causes any further damage to their organs. This information helps doctors understand the real-world benefits of this treatment.

The study will follow patients for two years. This longer timeframe allows the researchers to see the long-term effects of anifrolumab. By collecting information from many different hospitals and clinics, they hope to get a clear picture of how this medicine helps adult patients with lupus manage their condition over time.

Key takeaways

The study explores how anifrolumab works for lupus patients in real life.
It's an observational study, not a traditional drug trial.
Participation lasts for two years.
Information is gathered during your regular doctor visits.
Aims to understand long-term effects on lupus symptoms and quality of life.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and have been diagnosed with lupus (SLE). Your doctor must have decided that anifrolumab is the right treatment for you, and this decision should have been made before you consider joining the study. You also need to be able to understand the study information and give your written agreement to take part.

You cannot join if you have used anifrolumab before, either by injection or through a drip. You also can't take part if you are currently using other similar advanced biological medicines. If you are already in another clinical study that involves a new treatment, you won't be able to join this one.

There are also some specific medical situations that would prevent you from joining. For example, if you have certain severe kidney problems (lupus nephritis) or severe brain/nervous system lupus (neuropsychiatric lupus) that need urgent treatment. Additionally, if you have any serious health issues that would make it difficult to complete questionnaires or attend appointments for the next two years, or if you are pregnant or breastfeeding, this study would not be suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of lupus (SLE)?
Has your doctor recently prescribed anifrolumab for you, and you haven't used it before?
Are you able to agree to take part in the study in writing?
Are you not pregnant or breastfeeding?
Are you able to attend your regular doctor appointments for two years and complete questionnaires?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be followed for a period of two years. You'll continue to receive your anifrolumab as prescribed by your doctor, just as you would in your usual care – this study observes your normal treatment. You won't be asked to visit the clinic more often than usual. During your routine check-ups with your doctor, information will be collected about your lupus symptoms, how you're feeling, and any other medicines you're taking. You'll also be asked to complete questionnaires about your quality of life and how your lupus impacts you. There are no additional hospital visits or assessments beyond what your doctor already advises for your care. The study aims to fit into your normal healthcare routine.

Potential risks and benefits

Participating in this study might help us all learn more about how anifrolumab works for people with lupus in everyday life. This information could benefit other lupus patients in the future. As this study observes your usual care, there are no extra medical procedures or treatments that you wouldn't already be receiving. However, like any medicine, anifrolumab can have side effects, which your doctor will discuss with you. Taking part involves sharing your health information, but your privacy will be protected. You are free to withdraw from the study at any time without affecting your medical care.

Locations (16)

Research Site
Verified postcode
Altenburg, Germany· Recruiting
Research Site
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Bad Bramstedt, Germany· Recruiting
Research Site
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Berlin, Germany· Recruiting
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Chemnitz, Germany· Recruiting
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Erlangen, Germany· Recruiting
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Heidelberg, Germany· Recruiting
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Herne, Germany· Recruiting
Research Site
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Kassel, Germany· Recruiting
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Leipzig, Germany· Recruiting
Research Site
City only
Meerbusch-Lank, Germany· Recruiting
Research Site
Verified postcode
München, Germany· Recruiting
Research Site
Verified postcode
Planegg, Germany· Recruiting

Common questions

What is the main goal of the VIOLET study?

The main goal is to understand how anifrolumab works for people with lupus in real-life settings, looking at their disease activity and quality of life over two years.

Is this a trial where I might get a placebo?

No, this is not a trial where you might get a placebo. You will receive anifrolumab as prescribed by your doctor, as part of your normal treatment for lupus.

How long will I be in the study?

You will be in the study for two years, where researchers will observe your progress with anifrolumab treatment.

Will I have extra doctor's appointments because of the study?

No, you will not have extra appointments. The study collects information during your regular, routine visits with your doctor.

What information will the study collect about me?

The study will collect information about your lupus symptoms, how you feel, your quality of life, and any other medicines you are taking, all as part of your normal care.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.