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

Study acronym: Lupus-Best
StatusRecruiting
PhaseNot applicable
Started2023-12-12
View on ClinicalTrials.gov ↗

Amendment history

2026-06-16
Study Status, Contacts/Locations v4
Primary completion date2026-04-30→2029-12-31
Completion date2026-09-30→2030-03-31
Study sitescontacts updated at 2 of 14 sites
2025-08-22
Study Status, Contacts/Locations v3
Study sitesdetails revised at 11 of 14 sites
2024-02-26
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-10-01→confirmed 2023-12-12
Study sitesdetails revised at 14 of 14 sites
2023-09-21
Study Status v1
Start date2023-04-01→2023-10-01
2023-01-25
Original filing
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.
Trial Details
NCT Number NCT05714930
Lead Sponsor Heinrich-Heine University, Duesseldorf
Collaborators: University Hospital Heidelberg, German Diabetes-Center, Leibniz-Institut in Düsseldorf, Lupus Erythematodes-Selbsthilfegemeinschaft e.V.
Conditions Systemic Lupus Erythematosus
Enrollment 606 participants
Start Date 2023-12-12
Primary Completion 2029-12-31 (estimated)
Study Completion 2030-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-17