Treating systemic lupus erythematosus with a target approach

LUPUS-BEST - Treat-to-target in Systemic Lupus Erythematosus. A Multicenter Two-armed Cluster-randomized Controlled Trial

This study is testing if a new treatment approach that focuses on closely managing lupus can help patients feel better compared to the usual care they receive.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 606 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Heinrich-Heine University, Duesseldorf (Academic / other)
• Drugs / interventions: prednisone
• Locations: 14 sites (Freiburg im Breisgau, Baden-Wurttemberg and 13 other locations)
• Trial ID: NCT05714930 on ClinicalTrials.gov

What this trial studies

This multicenter trial evaluates the effectiveness of a treat-to-target (T2T) strategy in managing systemic lupus erythematosus (SLE) compared to standard care. Fourteen centers will be randomized to either T2T or standard of care, with 303 patients in each arm who are not in remission. The T2T approach involves tight control with frequent visits aimed at achieving remission, while the standard care arm will follow physician discretion for treatment adjustments. The study will last 120 weeks, focusing on damage progression and health-related quality of life as primary outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years with systemic lupus erythematosus who are not in remission.

Not a fit: Patients with life-threatening manifestations of SLE or other active malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved management and quality of life for patients with systemic lupus erythematosus.

How similar studies have performed: Previous studies have shown promise with treat-to-target strategies in other chronic conditions, suggesting potential success in this novel application for SLE.

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

Where this trial is running

Freiburg im Breisgau, Baden-Wurttemberg and 13 other locations

• University Clinic Freiburg — Freiburg im Breisgau, Baden-Wurttemberg, Germany (Recruiting)
• University Clinic Heidelberg — Heidelberg, Baden-Wurttemberg, Germany (Recruiting)
• University Clinic Erlangen — Erlangen, Bavaria, Germany (Not_yet_recruiting)
• LMU Munich — Munich, Bavaria, Germany (Recruiting)
• University Clinic Frankfurt — Frankfurt am Main, Hesse, Germany (Recruiting)
• Medical University Hannover — Hanover, Lower Saxony, Germany (Recruiting)
• University Clinic Düsseldorf — Düsseldorf, North Rhine-Westphalia, Germany (Recruiting)
• Kliniken Essen Mitte, Essen — Essen, North Rhine-Westphalia, Germany (Recruiting)
• Rheumazentrum Ruhrgebiet Herne, Ruhr University Bochum — Herne, North Rhine-Westphalia, Germany (Recruiting)
• University Clinic Münster — Münster, North Rhine-Westphalia, Germany (Recruiting)
• University Clinic Mainz — Mainz, Rhineland-Palatinate, Germany (Recruiting)
• University Medical Center TU Dresden — Dresden, Saxony, Germany (Recruiting)
• Charité - Berlin University of Medicine — Berlin, Germany (Recruiting)
• UKSH Campus Kiel — Kiel, Germany (Recruiting)

Study contacts

• Principal investigator: Matthias Schneider, MD — Heinrich-Heine University, Duesseldorf
• Study coordinator: Matthias Schneider, MD

Conditions Systemic Lupus Erythematosus; Treat-to-target; shared decision making