LUPUS-BEST - Treat-to-target in Systemic Lupus Erythematosus

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

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

Conditions2

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