LUPUS-BEST - Treat-to-target in Systemic Lupus Erythematosus. A Multicenter Two-armed Cluster-randomized Controlled Trial

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Charité - Berlin University of Medicine
RECRUITING
Berlin
University Medical Center TU Dresden
RECRUITING
Dresden
University Clinic Düsseldorf
RECRUITING
Düsseldorf
University Clinic Erlangen
NOT_YET_RECRUITING
Erlangen
Kliniken Essen Mitte, Essen
RECRUITING
Essen
University Clinic Frankfurt
RECRUITING
Frankfurt Am Main
University Clinic Freiburg
RECRUITING
Freiburg Im Breisgau
Medical University Hannover
RECRUITING
Hanover
University Clinic Heidelberg
RECRUITING
Heidelberg
Rheumazentrum Ruhrgebiet Herne, Ruhr University Bochum
RECRUITING
Herne
UKSH Campus Kiel
RECRUITING
Kiel
University Clinic Mainz
RECRUITING
Mainz
LMU Munich
RECRUITING
Munich
University Clinic Münster
RECRUITING
Münster
Contact Information
Primary
Matthias Schneider, MD
lupus-best@rheumanet.org
0211 81 17817
Backup
Johanna Mucke, MD
lupus-best@rheumanet.org
02118117817
Time Frame
Start Date: 2023-12-12
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 606
Treatments
Experimental: 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.
No_intervention: 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.
Related Therapeutic Areas
Sponsors
Collaborators: German Diabetes-Center, Leibniz-Institut in Düsseldorf, Lupus Erythematodes-Selbsthilfegemeinschaft e.V., University Hospital Heidelberg
Leads: Heinrich-Heine University, Duesseldorf

This content was sourced from clinicaltrials.gov