NCT05714930Recruiting
LUPUS-BEST - Treat-to-target in Systemic Lupus Erythematosus
LUPUS-BEST - Treat-to-target in Systemic Lupus Erythematosus. A Multicenter Two-armed Cluster-randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 17 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 606 (estimated)
- First submitted
- 10 Jan 2023
- Start date
- 12 Dec 2023
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Diseases
- Lupus (SLE)
- NCT number
- NCT05714930
What you commit to
- Study type: Interventional
- Planned participants: 606
- From 12 Dec 2023 to the primary completion date, 31 Dec 2029
- 14 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Participation in other interventional trial(s)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charité - Berlin University of Medicine Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| University Medical Center TU Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| University Clinic Düsseldorf Coordinator of this site? Confirm its status | Düsseldorf | Germany | Recruiting |
| University Clinic Erlangen Coordinator of this site? Confirm its status | Erlangen | Germany | Not yet recruiting |
| Kliniken Essen Mitte, Essen Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| University Clinic Frankfurt Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Recruiting |
| University Clinic Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Recruiting |
| Medical University Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Recruiting |
| University Clinic Heidelberg Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
| Rheumazentrum Ruhrgebiet Herne, Ruhr University Bochum Coordinator of this site? Confirm its status | Herne | Germany | Recruiting |
| UKSH Campus Kiel Coordinator of this site? Confirm its status | Kiel | Germany | Recruiting |
| University Clinic Mainz Coordinator of this site? Confirm its status | Mainz | Germany | Recruiting |
| LMU Munich Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| University Clinic Münster Coordinator of this site? Confirm its status | Münster | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.