RecruitingNAINTERVENTIONAL

LUPUS-BEST - Treat-to-target in Systemic Lupus Erythematosus

This study, called LUPUS-BEST, is looking at a new way to manage Systemic Lupus Erythematosus (SLE), often just called lupus. It's testing a strategy called "treat-to-target," where doctors work closely with patients to reach remission (a state where lupus symptoms are minimal) and then maintain it. They do this by seeing patients frequently, every six weeks, and adjusting medicines as needed. The study compares this intense approach with the usual way doctors treat lupus. Researchers want to see if this new method helps reduce lupus-related damage and improves how people feel and their quality of life over two years. It's a big study happening in 14 centres, involving over 600 patients in Germany.

At a glance

Status

Recruiting

Phase

Sponsor

Heinrich-Heine University, Duesseldorf

Enrolment target

606

Start

12 Dec 2023

Estimated completion

30 Sep 2026

Systemic Lupus Erythematosus

What is this study about?

If you have systemic lupus erythematosus (SLE), you might be interested in a new study called LUPUS-BEST. This study is exploring a different approach to managing lupus called "treat-to-target" (T2T). Think of it like setting a clear goal for your lupus treatment, which is to reach a state of remission. Remission means your lupus symptoms are very mild or non-existent, and you're possibly on a low dose of steroids. The idea is to work closely with your doctor to get you to this goal and then keep you there.

Currently, doctors usually adjust treatment based on how you're feeling and how active your lupus is during your regular appointments, which can be every few months. This study wants to see if a more focused and regular approach, where doctors check in with you more often (every six weeks) and adjust treatments more quickly, leads to better outcomes. They want to find out if this focused approach can help prevent damage caused by lupus and improve your overall quality of life.

This is a large study involving 14 different hospitals or clinics (called centres) in Germany. Some centres will use the new "treat-to-target" method, and others will continue with standard care. This allows researchers to compare the two approaches fairly and see if the new strategy is truly more effective for people living with lupus.

Key takeaways

Tests a new approach for lupus called 'treat-to-target'.
Aims to achieve and maintain lupus remission more quickly.
Compares frequent doctor visits with standard care.
Could help reduce lupus damage and improve quality of life.
Study lasts for two years and includes over 600 patients.

Who may be eligible?

To be part of this study, you need to be an adult, at least 18 years old, and have a confirmed diagnosis of Systemic Lupus Erythematosus (SLE) based on specific medical criteria. Importantly, you would need to be in a stage where your lupus is *not* in remission yet. This means you might still have active lupus symptoms, or your doctor might have you on more than 5mg of prednisolone daily, or they might feel your lupus isn't fully under control.

There are also some reasons why you might not be able to join. For example, if you're already taking part in another medical study, or if your doctor believes that being in this study wouldn't be safe for you or would make it hard to understand the results. This could include having a very sudden and severe flare-up of lupus that needs intensive care, or other serious health conditions like active cancer or certain infections that make it risky to change your immune-suppressing medicines.

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.

Do I have a confirmed diagnosis of Systemic Lupus Erythematosus (SLE)?
Am I 18 years old or older?
Is my lupus currently not in remission (e.g., active symptoms, on >5mg prednisolone)?
Am I able to understand and speak German fluently? (This study is conducted in Germany.)
Am I currently not part of another medical treatment study?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be part of it for two years (120 weeks). If your centre is using the new "treat-to-target" method and your lupus isn't in remission, you'll have more frequent visits. Initially, you'd come in every six weeks. During these visits, your doctors would check your lupus activity and, working with you, adjust your treatments to try and get your lupus into remission. Once you reach remission and stay there, your visits would be every 12 weeks. If your lupus flares up again, you might go back to the more frequent visits to get it under control. If your centre provides standard care, your visits would happen every 3 to 6 months, and your doctor would adjust your treatment as they usually do. The study will track how your lupus affects your health over time and your overall quality of life.

Potential risks and benefits

Participating in this study might mean your lupus is monitored more closely, which could potentially lead to quicker adjustments in your treatment and better control of your symptoms, possibly reducing future damage from lupus. However, with more frequent treatment adjustments, there's always a possibility of experiencing new side effects from medications, even though your doctors will carefully monitor you. As with any study, you are free to leave at any time without giving a reason, and your regular medical care will not be affected.

Locations (14)

University Clinic Freiburg
Verified postcode
Freiburg im Breisgau, Germany· Recruiting
University Clinic Heidelberg
Verified postcode
Heidelberg, Germany· Recruiting
University Clinic Erlangen
Verified postcode
Erlangen, Germany· Not yet recruiting
LMU Munich
Verified postcode
Munich, Germany· Recruiting
University Clinic Frankfurt
Verified postcode
Frankfurt am Main, Germany· Recruiting
Medical University Hannover
Verified postcode
Hanover, Germany· Recruiting
University Clinic Düsseldorf
Verified postcode
Düsseldorf, Germany· Recruiting
Kliniken Essen Mitte, Essen
Verified postcode
Essen, Germany· Recruiting
Rheumazentrum Ruhrgebiet Herne, Ruhr University Bochum
Verified postcode
Herne, Germany· Recruiting
University Clinic Münster
Verified postcode
Münster, Germany· Recruiting
University Clinic Mainz
Verified postcode
Mainz, Germany· Recruiting
University Medical Center TU Dresden
Verified postcode
Dresden, Germany· Recruiting

Common questions

What is 'treat-to-target'?

It's a treatment approach where doctors set a clear goal, like getting your lupus into remission, and then work to achieve and maintain that goal with regular check-ups and treatment adjustments.

What is remission in lupus?

For this study, remission means having very low or no lupus symptoms, taking a low dose of steroids (5mg or less per day), and your doctor feeling your lupus is well controlled.

How long will the study last if I join?

The study will last for two years, or 120 weeks, from when you start.

Will I get new medicines in this study?

The study is about how doctors manage your current lupus medicines, not necessarily about giving you brand new medicines you haven't taken before. Any changes would be to your existing treatments.

Who is paying for this study?

The information provided doesn't specify the funding body for this particular study.

How to find out more

Matthias Schneider, MD

lupus-best@rheumanet.org 0211 81 17817 Official trial record

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