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

Launched by HEINRICH-HEINE UNIVERSITY, DUESSELDORF · Jan 25, 2023

Keywords

ClinConnect Summary

The LUPUS-BEST trial is a research study looking at a new way to treat people with systemic lupus erythematosus (SLE), a condition that causes the immune system to attack the body. This study will compare two different treatment approaches: one group of patients will follow a "treat-to-target" strategy, which means they will have regular check-ups every six weeks to aim for remission (a state where the disease's active symptoms are gone), while the other group will receive standard care, where treatment adjustments are made based on their doctor's discretion. The trial will include 606 patients from 14 centers across the country and will last for about 120 weeks, focusing on how well patients feel and any damage caused by the disease.

To participate in this trial, patients must be at least 18 years old, speak German, and currently have SLE that is not in remission. This means they need to show some level of disease activity according to specific medical guidelines. Patients who are involved can expect regular appointments and close monitoring of their health throughout the study. It's important to note that people with certain serious health conditions or those participating in other clinical trials may not be eligible to join. This study aims to find better ways to manage SLE and improve the quality of life for those affected by it.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with SLE according to validated classification criteria
• • Age at least 18 years
• • Not in a stage of remission due to
• • 1. Clinical SLEDAI \> 0 AND/OR
• • 2. GC dosage above 5 mg prednisone equivalent per day AND/OR
• • 3. Physician global assessment ≥ 0.5 on a visual analogue scale (VAS) from 0 to 3
• • Fluent German language skills
• • Written informed consent
• Exclusion Criteria:
• • Participation in other interventional trial(s)
• * Any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this study, would interfere with the interpretation of subject safety or study results, or is considered unsuitable by the investigator for any other reason. Examples could be:
• • Life-threatening SLE manifestations that require intensive care treatment
• • Active life-threatening diseases other than SLE
• • Active malignancies
• • Acute and chronic infections that do not allow the intensification of immunosuppressive treatment