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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.

Auf einen Blick

Status
Rekrutierung
Phase
NA
Sponsor
Heinrich-Heine University, Duesseldorf
Einschreibeziel
606
Starten
12 Dec 2023
Geschätzte Fertigstellung
30 Sep 2026

Worum geht es in dieser Studie?

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.

Wichtige Erkenntnisse

  • 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.

Wer könnte berechtigt sein?

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.

Könnte diese Studie für Sie geeignet sein?

Beantworten Sie diese kurzen Fragen, um zu sehen, ob Sie möglicherweise berechtigt sind. Dies ist nur ein Leitfaden – das Forschungsteam trifft die endgültige Entscheidung.

  1. Do I have a confirmed diagnosis of Systemic Lupus Erythematosus (SLE)?
  2. Bin ich 18 Jahre alt oder älter?
  3. Is my lupus currently not in remission (e.g., active symptoms, on >5mg prednisolone)?
  4. Am I able to understand and speak German fluently? (This study is conducted in Germany.)
  5. Am I currently not part of another medical treatment study?
Beantworten Sie jede Frage, um Ihr Ergebnis zu sehen.

Was beinhaltet die Teilnahme?

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.

Potenzielle Risiken und Vorteile

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.

Standorte (14)

  • University Clinic Freiburg
    Verifizierte Postleitzahl
    Freiburg im Breisgau, Germany· Rekrutierung
  • University Clinic Heidelberg
    Verifizierte Postleitzahl
    Heidelberg, Deutschland· Rekrutierung
  • University Clinic Erlangen
    Verifizierte Postleitzahl
    Erlangen, Germany· Noch nicht rekrutiert
  • LMU Munich
    Verifizierte Postleitzahl
    München, Deutschland· Rekrutierung
  • University Clinic Frankfurt
    Verifizierte Postleitzahl
    Frankfurt am Main, Germany· Rekrutierung
  • Medical University Hannover
    Verifizierte Postleitzahl
    Hannover, Deutschland· Rekrutierung
  • University Clinic Düsseldorf
    Verifizierte Postleitzahl
    Düsseldorf, Germany· Rekrutierung
  • Kliniken Essen Mitte, Essen
    Verifizierte Postleitzahl
    Essen, Germany· Rekrutierung
  • Rheumazentrum Ruhrgebiet Herne, Ruhr University Bochum
    Verifizierte Postleitzahl
    Herne, Germany· Rekrutierung
  • University Clinic Münster
    Verifizierte Postleitzahl
    Münster, Germany· Rekrutierung
  • University Clinic Mainz
    Verifizierte Postleitzahl
    Mainz, Germany· Rekrutierung
  • University Medical Center TU Dresden
    Verifizierte Postleitzahl
    Dresden, Deutschland· Rekrutierung

Häufige Fragen

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.

Wie lange wird die Studie dauern, wenn ich teilnehme?

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.

Wer bezahlt für diese Studie?

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

Wie Sie mehr erfahren können

Matthias Schneider, MD

Sprechen Sie immer mit Ihrem Hausarzt oder Spezialisten, bevor Sie sich entscheiden, an einer Studie teilzunehmen.

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