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

NCT05714930 · tracked via the Priya Life Science Germany tracker

Sponsor

Heinrich-Heine University, Duesseldorf

Phase

Not applicable

Started

2023-12-12

Last updated

2026-06-17

Condition(s) studied

Systemic Lupus Erythematosus

Investigational drug(s) / intervention(s)

Treat-to-target as a new treatment concept

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Damage accrual — week 120
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.

Trial sites (14)

Facility	City	Region	Status
University Clinic Freiburg	Freiburg im Breisgau	Baden-Wurttemberg	Recruiting
University Clinic Heidelberg	Heidelberg	Baden-Wurttemberg	Recruiting
University Clinic Erlangen	Erlangen	Bavaria	Not Yet Recruiting
LMU Munich	Munich	Bavaria	Recruiting
University Clinic Frankfurt	Frankfurt am Main	Hesse	Recruiting
Medical University Hannover	Hanover	Lower Saxony	Recruiting
University Clinic Düsseldorf	Düsseldorf	North Rhine-Westphalia	Recruiting
Kliniken Essen Mitte, Essen	Essen	North Rhine-Westphalia	Recruiting
Rheumazentrum Ruhrgebiet Herne, Ruhr University Bochum	Herne	North Rhine-Westphalia	Recruiting
University Clinic Münster	Münster	North Rhine-Westphalia	Recruiting
University Clinic Mainz	Mainz	Rhineland-Palatinate	Recruiting
University Medical Center TU Dresden	Dresden	Saxony	Recruiting
Charité - Berlin University of Medicine	Berlin	Germany	Recruiting
UKSH Campus Kiel	Kiel	Germany	Recruiting

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Other trials for the same condition

Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2) Active, not recruiting

A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) Active, not recruiting

Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension). Recruiting

A First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7507062 in Participants With Systemic Lupus Erythematosus Active, not recruiting

An Open-label, Study to Assess Safety, Efficacy and Cellular Kinetics of YTB323 in Severe, Refractory Systemic Lupus Erythematosus Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05714930 on ClinicalTrials.gov ↗ ← All trials in Germany