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New treatment option for Systemic Lupus Erythematosus
Official title LUPUS-BEST - Treat-to-target in Systemic Lupus Erythematosus
ClinicalTrials.gov ID: NCT05714930
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Participation in other treatment trial(s)
- Any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this study, would interfere with the...
- 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
See the full eligibility criteria
- 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
- Participation in other treatment trial(s)
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Freiburg im Breisgau, Baden-Wurttemberg, Germany
- Heidelberg, Baden-Wurttemberg, Germany
- Erlangen, Bavaria, Germany
- Munich, Bavaria, Germany
- Frankfurt am Main, Hesse, Germany
- Hanover, Lower Saxony, Germany
- Düsseldorf, North Rhine-Westphalia, Germany
- Essen, North Rhine-Westphalia, Germany
- Herne, North Rhine-Westphalia, Germany
- Münster, North Rhine-Westphalia, Germany
- Mainz, Rhineland-Palatinate, Germany
- Dresden, Saxony, Germany
- Berlin, Germany
- Kiel, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Freiburg im Breisgau, Baden-Wurttemberg, Germany; Heidelberg, Baden-Wurttemberg, Germany; Erlangen, Bavaria, Germany; Munich, Bavaria, Germany; Frankfurt am Main, Hesse, Germany; Hanover, Lower Saxony, Germany and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.