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LUPUS-BEST - Treat-to-target in Systemic Lupus Erythematosus
Sponsor: Heinrich-Heine University, Duesseldorf
Summary
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.
Official title: LUPUS-BEST - Treat-to-target in Systemic Lupus Erythematosus. A Multicenter Two-armed Cluster-randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
606
Start Date
2023-12-12
Completion Date
2026-09-30
Last Updated
2025-08-24
Healthy Volunteers
No
Conditions
Interventions
Treat-to-target as a new treatment concept
After trial initiation, the study personnel in the intervention centers will receive a training on T2T and shared decision making (SDM). Patients in the intervention centers will receive 6-weekly visits for at least 24 weeks with therapeutic adjustments to achieve remission. In case of stable remission for 6 weeks at week 24, the patients switch to 12-weekly visits until the end of the trial at week 120. In case of flare, the patient switches to 6-weekly visits for 24 consecutive weeks. Pharmaceutical treatment decisions will be guided by current treatment standards and will be taken in accordance with SDM between patients and treating physicians.
Locations (14)
University Clinic Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
University Clinic Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
University Clinic Erlangen
Erlangen, Bavaria, Germany
LMU Munich
Munich, Bavaria, Germany
University Clinic Frankfurt
Frankfurt am Main, Hesse, Germany
Medical University Hannover
Hanover, Lower Saxony, Germany
University Clinic Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany
Kliniken Essen Mitte, Essen
Essen, North Rhine-Westphalia, Germany
Rheumazentrum Ruhrgebiet Herne, Ruhr University Bochum
Herne, North Rhine-Westphalia, Germany
University Clinic Münster
Münster, North Rhine-Westphalia, Germany
University Clinic Mainz
Mainz, Rhineland-Palatinate, Germany
University Medical Center TU Dresden
Dresden, Saxony, Germany
Charité - Berlin University of Medicine
Berlin, Germany
UKSH Campus Kiel
Kiel, Germany