Tests a treat-to-target approach for lupus patients not in remission
Tests a close-monitoring treatment plan in adults with lupus not in remission.
Plain-language title generated from the registry record
Registry title: LUPUS-BEST - Treat-to-target in Systemic Lupus Erythematosus
Key facts
- Where
- Berlin, Dresden, Düsseldorf, Erlangen, Essen, Frankfurt am Main, Freiburg im Breisgau, Hanover, Heidelberg, Herne, Kiel, Mainz, Munich, and Münster, GermanySee the 14 sites
Where in Germany
- Charité - Berlin University of MedicineBerlin, GermanyTaking people
- University Medical Center TU DresdenDresden, GermanyTaking people
- University Clinic DüsseldorfDüsseldorf, GermanyTaking people
- University Clinic ErlangenErlangen, GermanyNot yet recruiting
- Kliniken Essen Mitte, EssenEssen, GermanyTaking people
- University Clinic FrankfurtFrankfurt am Main, GermanyTaking people
- University Clinic FreiburgFreiburg im Breisgau, GermanyTaking people
- Medical University HannoverHanover, GermanyTaking people
- University Clinic HeidelbergHeidelberg, GermanyTaking people
- Rheumazentrum Ruhrgebiet Herne, Ruhr University BochumHerne, GermanyTaking people
- UKSH Campus KielKiel, GermanyTaking people
- University Clinic MainzMainz, GermanyTaking people
- LMU MunichMunich, GermanyTaking people
- University Clinic MünsterMünster, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Heinrich-Heine University, Duesseldorf
- Trial code
- NCT05714930
- Record updated
- 17 June 2026
- Original description
Multicenter, national, two-armed cluster-randomized controlled trial to evaluate the effect of a treat-to-target (T2T) strategy in in systemic lupus erythematosus (SLE). 14 centers will be randomized 1:1 to T2T or standard of care. Per arm 303 patients with SLE who are not in remission will be included and receive either tight control with 6-weekly visits with the aim to reach remission or SoC with control visits and treatment adjustment according to the physicians discretion. Study duration is 120 weeks using damage accrual and Health related Quality of Life as major outcomes.Read full original descriptionShow less
LUPUS-BEST - Treat-to-target in Systemic Lupus Erythematosus. A Multicenter Two-armed Cluster-randomized Controlled Trial
Multicenter, national, two-armed cluster-randomized controlled trial to evaluate the effect of a treat-to-target (T2T) strategy in in systemic lupus erythematosus (SLE). 14 centers will be randomized 1:1 to T2T or standard of care. Per arm 303 patients with SLE who are not in remission will be included and receive either tight control with 6-weekly visits with the aim to reach remission or SoC with control visits and treatment adjustment according to the physicians discretion. Study duration is 120 weeks using damage accrual and Health related Quality of Life as major outcomes.
Inclusion: Patients with SLE according to validated classification criteria; Age at least 18 years; Not in a stage of remission due to; Clinical SLEDAI > 0 AND/OR; GC dosage above 5 mg prednisone equivalent per day AND/OR; Physician global assessment ≥ 0.5 on a visual analogue scale (VAS) from 0 to 3; Fluent German language skills; Written informed consent.
Exclusion: 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; Participation in other interventional trial(s).