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

NCT ID: NCT05714930

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 606 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-12
• Study Completion Date: 2026-09-30

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.

Detailed Description

This is a 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) on damage progression and health related quality of life (HRQoL). The study centers will be assigned 1:1 to standard of care (SoC) or remission, defined as the absence of clinical disease activity (clinical SLEDAI =0) AND prednisolone ≤5mg/day AND physician global assessment (PGA) <0.5 on a VAS 0-3. Patient with SLE > 18 years of age who are not in remission will be eligible.

Per arm, 303 patients will be included. Intervention centers receive a standardized training on T2T and shared decision making (SDM). In the intervention centers, patients not on target enter a phase of tight control with 6-weekly visits and treatment adjustments (at least 4 visits) or until remission is reached and maintained. Patients in remission are reassessed every 12 weeks. In case of flare, they can re-enter tight control based on SDM. In the SoC arm, patients receive 3- to 6-monthly controls and treatment adjustments according to the physician's discretion. Study duration is 120 weeks using damage accrual and HRQoL as major outcomes.

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treat-to-target

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.

Group Type: EXPERIMENTAL

Treat-to-target as a new treatment concept

Intervention Type: 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.

Standard of Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Heidelberg

OTHER

Sponsor Role: collaborator

German Diabetes-Center, Leibniz-Institut in Düsseldorf

OTHER

Sponsor Role: collaborator

Lupus Erythematodes-Selbsthilfegemeinschaft e.V.

UNKNOWN

Sponsor Role: collaborator

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthias Schneider, MD

Role: PRINCIPAL_INVESTIGATOR

Heinrich-Heine University, Duesseldorf

Locations

University Clinic Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status: RECRUITING

University Clinic Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Site Status: RECRUITING

University Clinic Erlangen

Erlangen, Bavaria, Germany

Site Status: NOT_YET_RECRUITING

LMU Munich

Munich, Bavaria, Germany

Site Status: RECRUITING

University Clinic Frankfurt

Frankfurt am Main, Hesse, Germany

Site Status: RECRUITING

Medical University Hannover

Hanover, Lower Saxony, Germany

Site Status: RECRUITING

University Clinic Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Kliniken Essen Mitte, Essen

Essen, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Rheumazentrum Ruhrgebiet Herne, Ruhr University Bochum

Herne, North Rhine-Westphalia, Germany

Site Status: RECRUITING

University Clinic Münster

Münster, North Rhine-Westphalia, Germany

Site Status: RECRUITING

University Clinic Mainz

Mainz, Rhineland-Palatinate, Germany

Site Status: RECRUITING

University Medical Center TU Dresden

Dresden, Saxony, Germany

Site Status: RECRUITING

Charité - Berlin University of Medicine

Berlin, , Germany

Site Status: RECRUITING

UKSH Campus Kiel

Kiel, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Matthias Schneider, MD

Role: CONTACT

lupus-best@rheumanet.org

0211 81 17817

Johanna Mucke, MD

Role: CONTACT

lupus-best@rheumanet.org

02118117817

Facility Contacts

Stephanie Finzel, MD

Role: primary

Hanns Martin Lorenz, MD

Role: primary

Ricardo Grieshaber-Bouyer, MD

Role: primary

Hendrik Schulze-Koops, MD

Role: primary

Michaela Köhm, MD

Role: primary

Torsten Witte, MD

Role: primary

Chehab Gamal, MD

Role: primary

Christof Specker, MD

Role: primary

Ioana Andreica, MD

Role: primary

Martin Kriegel, MD

Role: primary

Andreas Schwarting, MD

Role: primary

Martin Aringer, MD

Role: primary

Tobias Alexander, MD

Role: primary

Sorwe Mojtahed Poor, MD

Role: primary

Other Identifiers

LUPUS-BEST

Identifier Type: -

Identifier Source: org_study_id