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

NCT05714930 | Recruiting DMC

• 1 other identifier: LUPUS-BEST
• Study Type: interventional
• Target: 606
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Systemic Lupus Erythematosus

Keywords

Treat-to-target; shared decision making

Outcome Measures

Primary Outcomes (1)

• Damage accrual

  Damage is defined as irreversible disease associated damage, captured by the Systemic Lupus International Collaborating Clinics/ American College of Rheumatology (SLICC/ACR-) damage index (SDI). The SDI is a validated tool to assess irreversible damage that has occurred since onset of lupus. It ranges from 0 (no damage) to 44 (highest achievable damage and worst outcome). Primary endpoint is the difference of damage accrued over 120 weeks between the two arms after 120 weeks.

  week 120

Secondary Outcomes (16)

• Health Related Quality of Life (HRQoL)

  week 120

• Disease activity reported by physicians

  week 120

• Patient-reported disease activity

  week 120

• Cumulative time in remission

  120 weeks

• Cumulative number of new organ manifestations

  120 weeks

Study Arms (2)

Treat-to-target

EXPERIMENTAL

T2T will be implemented based on shared decision-making (SDM), tight control and remission as a validated treatment target (disease activity score clinical SLEDAI-2k = 0 \& glucocorticoids (GC) ≤ 5 mg prednisolone equivalent \& physician global assessment (PGA 0-3) \< 0.5 ± immunomodulatory therapy); All intervention centers will receive T2T/SDM trainings. Patients not meeting their target criterion at study entry or at any time during the trial will be included in a tight control T2T loop of 24 weeks with assessments every 6 weeks to reach the target by adjustments of their immunomodulatory treatments. Patients in target will be assessed every 12 weeks as it is standard in clinical routine care.

Other: Treat-to-target as a new treatment concept

Standard of Care

NO INTERVENTION

In the standard of care (SoC) arm, patients receive 3-to 6-monthly controls and treatment adjustments according to their physician's discretion.

Interventions

Treat-to-target as a new treatment concept OTHER

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.

Treat-to-target

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead
• University Hospital Heidelberg: collaborator
• German Diabetes-Center, Leibniz-Institut in Düsseldorf: collaborator
• Lupus Erythematodes-Selbsthilfegemeinschaft e.V.: collaborator

Study Sites (14)

University Clinic Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

RECRUITING

University Clinic Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

University Clinic Erlangen

Erlangen, Bavaria, 91054, Germany

NOT YET RECRUITING

LMU Munich

Munich, Bavaria, 80336, Germany

RECRUITING

University Clinic Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

RECRUITING

Medical University Hannover

Hanover, Lower Saxony, 30625, Germany

RECRUITING

University Clinic Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

RECRUITING

Kliniken Essen Mitte, Essen

Essen, North Rhine-Westphalia, 45136, Germany

RECRUITING

Rheumazentrum Ruhrgebiet Herne, Ruhr University Bochum

Herne, North Rhine-Westphalia, 44649, Germany

RECRUITING

University Clinic Münster

Münster, North Rhine-Westphalia, 48149, Germany

RECRUITING

University Clinic Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

RECRUITING

University Medical Center TU Dresden

Dresden, Saxony, 01307, Germany

RECRUITING

Charité - Berlin University of Medicine

Berlin, 10117, Germany

RECRUITING

UKSH Campus Kiel

Kiel, 24105, Germany

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Matthias Schneider, MD

  Heinrich-Heine University, Duesseldorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias Schneider, MD

CONTACT

0211 81 17817; lupus-best@rheumanet.org

Johanna Mucke, MD

CONTACT

02118117817; lupus-best@rheumanet.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, national, two-armed cluster-randomized controlled trial

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: February 6, 2023
• Study Start: December 12, 2023
• Primary Completion: April 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-08

Locations

DE (14)