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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Treat-to-target as a new treatment concept
Other interventionAfter trial initiation, the study personnel in the intervention centers will receive a training on T2T and shared decision making (SDM). Patients in the intervention centers will receive 6-weekly visits for at least 24 weeks with therapeutic adjustments to achieve remission. In case of stable remission for 6 weeks at week 24, the patients switch to 12-weekly visits until the end of the trial at week 120. In case of flare, the patient switches to 6-weekly visits for 24 consecutive weeks. Pharmaceutical treatment decisions will be guided by current treatment standards and will be taken in accordance with SDM between patients and treating physicians.
Treatment groups
606 Participants
are divided into 2 treatment groupsGroup A: Treat-to-targetExperimental treatment 1 intervention
Group B: Standard of CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Damage accrual
Damage is defined as irreversible disease associated damage, captured by the Systemic Lupus International Collaborating Clinics/ American College of Rheumatology (SLICC/ACR-) damage index (SDI). The SDI is a validated tool to assess irreversible damage that has occurred since onset of lupus. It ranges from 0 (no damage) to 44 (highest achievable damage and worst outcome). Primary endpoint is the difference of damage accrued over 120 weeks between the two arms after 120 weeks.
Time frame
week 120Secondary outcomes
1
Health Related Quality of Life (HRQoL)
Health related quality of life (HRGoL) is measured by the Short Form 36 questionnaire (SF-36), an established, patient-reported health survey. It contains 36 items in 8 sections. The lower the score, the higher the level of disability, "0"equalling maximum, a score of 100 no disability. Defined as the difference in Health Related Quality of Life between the two arms at week 120. HRQoL is measured by the disease independent Short Form 36 questionnaire (SF-36).
Time frame
week 1202
Disease activity reported by physicians
Defined as the difference in Systemic Lupus Erythematodes Disease Activity Index 2000 (SLEDAI-2K) between the two arms at week 120. The SLEDAI-2K is a validated measuring tool for disease activity of SLE. Specific manifestations in 9 organ systems are evaluated. There are 24 descriptors included. 16 items are clinical, 8 are based solely on laboratory test results. They are weighted differently based on severity. The final score ranges from 0 (no disease activity) to a maximum of 105 points (highest disease activity).
Time frame
week 1203
Patient-reported disease activity
Defined as the difference in Systemic Lupus Activity Questionnaire (SLAQ) between the two arms at week 120. The SLAQ asks the patient to rate disease activity on a scale of 0-10 over the past 3 months. It consists of 24 items in 9 organs/systems. Regarding disease activity, 0 is defined as no problem, 1 mild, 2 moderate and 3 severe disease activity. The respective numeric rating scale ranges from 0 = "no activity", to 10 = "most activity".
Time frame
week 1204
Cumulative time in remission
Remission is defined as * Clinical SLEDAI-2K = 0 AND * Physician global assessment (VAS 0-3) \< 0.5 AND * Prednisone \< 5mg/d The Systemic Lupus Erythematodes Disease Activity Index 2000 (SLEDAI-2K) is a validated measuring tool for disease activity of SLE. Specific manifestations in 9 organ systems are evaluated. There are 24 descriptors included. 16 items are clinical, 8 are based solely on laboratory test results. They are weighted differently based on severity. The final score ranges from 0 (no disease activity) to a maximum of 105 points (highest disease activity). I Physician Global Assessment is a clinical tool to assess disease activity from the clinician's perspective (rater). It is measured on a Visual Analogous Scale from 0 (no disease activity) to 3 (most severe disease activity). Assessed will be the cumulative time in remission between the two arms over 120 weeks.
Time frame
120 weeksSponsors and contacts
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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