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

NCT05714930 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 606

Last updated 2025-08-24

No results posted yet for this 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.

Conditions

Interventions

OTHER

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.

Sponsors & Collaborators

  • University Hospital Heidelberg

    collaborator OTHER

  • German Diabetes-Center, Leibniz-Institut in Düsseldorf

    collaborator OTHER

  • Lupus Erythematodes-Selbsthilfegemeinschaft e.V.

    collaborator UNKNOWN

  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Principal Investigators

  • Matthias Schneider, MD · Heinrich-Heine University, Duesseldorf

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-12
Primary Completion
2026-04-30
Completion
2026-09-30

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05714930 on ClinicalTrials.gov