LUPUS-BEST - Treat-to-target in Systemic Lupus Erythematosus
ConditionSystemic Lupus Erythematosus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHeinrich-Heine University, Duesseldorf
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Participation in other interventional trial(s)
Life-threatening SLE manifestations that require intensive care treatment
Active life-threatening diseases other than SLE
Active malignancies
Trial design
Treatments tested in this trial
- Treat-to-target as a new treatment concept
Treatment groups
606 Participants
are divided into 2 treatment groupsSponsors and collaborators
Heinrich-Heine University, Duesseldorf
Lead sponsor
University Hospital Heidelberg
Collaborator
German Diabetes-Center, Leibniz-Institut in Düsseldorf
Collaborator
Lupus Erythematodes-Selbsthilfegemeinschaft e.V.
Collaborator
Source ClinicalTrials.gov