Actively Recruiting
LUPUS-BEST - Treat-to-target in Systemic Lupus Erythematosus
Led by Heinrich-Heine University, Duesseldorf · Updated on 2025-08-24
606
Participants Needed
14
Research Sites
146 weeks
Total Duration
On this page
Sponsors
H
Heinrich-Heine University, Duesseldorf
Lead Sponsor
U
University Hospital Heidelberg
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
LUPUS-BEST - Treat-to-target in Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with systemic lupus erythematosus according to validated classification criteria
- Age at least 18 years
- Not in remission due to clinical SLEDAI greater than 0 and/or glucocorticoid dosage above 5 mg prednisone equivalent per day and/or physician global assessment 0.5 or higher on a visual analogue scale from 0 to 3
- Fluent German language skills
- Written informed consent
You will not qualify if you...
- Participation in other interventional trials
- Any disease or condition that makes the subject unsuitable for the study or interferes with safety or results, such as:
- Life-threatening lupus manifestations requiring intensive care
- Active life-threatening diseases other than lupus
- Active malignancies
- Acute or chronic infections preventing immunosuppressive treatment intensification
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
University Clinic Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
Actively Recruiting
2
University Clinic Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
3
University Clinic Erlangen
Erlangen, Bavaria, Germany, 91054
Not Yet Recruiting
4
LMU Munich
Munich, Bavaria, Germany, 80336
Actively Recruiting
5
University Clinic Frankfurt
Frankfurt am Main, Hesse, Germany, 60590
Actively Recruiting
6
Medical University Hannover
Hanover, Lower Saxony, Germany, 30625
Actively Recruiting
7
University Clinic Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany, 40225
Actively Recruiting
8
Kliniken Essen Mitte, Essen
Essen, North Rhine-Westphalia, Germany, 45136
Actively Recruiting
9
Rheumazentrum Ruhrgebiet Herne, Ruhr University Bochum
Herne, North Rhine-Westphalia, Germany, 44649
Actively Recruiting
10
University Clinic Münster
Münster, North Rhine-Westphalia, Germany, 48149
Actively Recruiting
11
University Clinic Mainz
Mainz, Rhineland-Palatinate, Germany, 55131
Actively Recruiting
12
University Medical Center TU Dresden
Dresden, Saxony, Germany, 01307
Actively Recruiting
13
Charité - Berlin University of Medicine
Berlin, Germany, 10117
Actively Recruiting
14
UKSH Campus Kiel
Kiel, Germany, 24105
Actively Recruiting
Research Team
M
Matthias Schneider, MD
CONTACT
J
Johanna Mucke, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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