Treating systemic lupus erythematosus with a target approach

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter trial evaluates the effectiveness of a treat-to-target (T2T) strategy in managing systemic lupus erythematosus (SLE) compared to standard care. Fourteen centers will be randomized to either T2T or standard of care, with 303 patients in each arm who are not in remission. The T2T approach involves tight control with frequent visits aimed at achieving remission, while the standard care arm will follow physician discretion for treatment adjustments. The study will last 120 weeks, focusing on damage progression and health-related quality of life as primary outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with SLE according to validated classification criteria
* Age at least 18 years
* Not in a stage of remission due to

  1. Clinical SLEDAI \> 0 AND/OR
  2. GC dosage above 5 mg prednisone equivalent per day AND/OR
  3. Physician global assessment ≥ 0.5 on a visual analogue scale (VAS) from 0 to 3
* Fluent German language skills
* Written informed consent

Exclusion Criteria:

* Participation in other interventional 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 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

Where it's running

• University Clinic Freiburg
  Freiburg im Breisgau, Baden-Wurttemberg, Germany Recruiting
• University Clinic Heidelberg
  Heidelberg, Baden-Wurttemberg, Germany Recruiting
• LMU Munich
  Munich, Bavaria, Germany Recruiting
• University Clinic Frankfurt
  Frankfurt am Main, Hesse, Germany Recruiting
• Medical University Hannover
  Hanover, Lower Saxony, Germany Recruiting
• University Clinic Düsseldorf
  Düsseldorf, North Rhine-Westphalia, Germany Recruiting

Study contacts

• Principal investigator: Matthias Schneider, MD — Heinrich-Heine University, Duesseldorf
• Study coordinator: Matthias Schneider, MD
• Email: lupus-best@rheumanet.org
• Phone: 0211 81 17817

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Biomarker tests in adults with lupus to see how kidney disease changes over time

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.