Clinical trial NCT05714930: LUPUS-BEST - Treat-to-target in Systemic Lupus Erythematosus
Official title: LUPUS-BEST - Treat-to-target in Systemic Lupus Erythematosus. A Multicenter Two-armed Cluster-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Systemic Lupus Erythematosus
Keywords: Treat-to-target
shared decision making
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
Collaborators: name: University Hospital Heidelberg
name: German Diabetes-Center, Leibniz-Institut in Düsseldorf
name: Lupus Erythematodes-Selbsthilfegemeinschaft e.V.
First posted: 2023-02-06
Enrollment: 606
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, national, two-armed cluster-randomized controlled trial
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a 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) on damage progression and health related quality of life (HRQoL). The study centers will be assigned 1:1 to standard of care (SoC) or remission, defined as the absence of clinical disease activity (clinical SLEDAI =0) AND prednisolone ≤5mg/day AND physician global assessment (PGA) \<0.5 on a VAS 0-3. Patient with SLE \> 18 years of age who are not in remission will be eligible.

Per arm, 303 patients will be included. Intervention centers receive a standardized training on T2T and shared decision making (SDM). In the intervention centers, patients not on target enter a phase of tight control with 6-weekly visits and treatment adjustments (at least 4 visits) or until remission is reached and maintained. Patients in remission are reassessed every 12 weeks. In case of flare, they can re-enter tight control based on SDM. In the SoC arm, patients receive 3- to 6-monthly controls and treatment adjustments according to the physician's discretion. Study duration is 120 weeks using damage accrual and HRQoL as major outcomes.

Eligibility criteria: 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

Primary outcomes:
measure: Damage accrual
timeFrame: week 120
Secondary outcomes:
measure: Health Related Quality of Life (HRQoL)
timeFrame: week 120
measure: Disease activity reported by physicians
timeFrame: week 120
measure: Patient-reported disease activity
timeFrame: week 120
measure: Cumulative time in remission
timeFrame: 120 weeks
measure: Cumulative number of new organ manifestations
timeFrame: 120 weeks
measure: Time to achieve remission
timeFrame: 120 weeks
measure: Cumulative glucocorticoid (GC) dosage at week 120
timeFrame: week 120
measure: Percentage of patients refusing remission as target
timeFrame: 120 weeks
measure: Percentage of physicians refusing remission as target
timeFrame: 120 weeks
measure: Drug adherence
timeFrame: 120 weeks
measure: Fatigue
timeFrame: 120 weeks
measure: Fatigue
timeFrame: 120 weeks
measure: Work productivity
timeFrame: 120 weeks
measure: Evaluation of shared decision-making (SDM) by patients
timeFrame: 120 weeks
measure: Evaluation of shared decision-making by physicians
timeFrame: 120 weeks
measure: Evaluation of health utilities
timeFrame: 120 weeks
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: University Clinic Freiburg
state: Baden Wurttemberg
city: Heidelberg
country: Germany
facility: University Clinic Heidelberg
state: Baden Wurttemberg
city: Erlangen
country: Germany
facility: University Clinic Erlangen
state: Bavaria
city: Munich
country: Germany
facility: LMU Munich
state: Bavaria
city: Frankfurt am Main
country: Germany
facility: University Clinic Frankfurt
state: Hessen
city: Hannover
country: Germany
facility: Medical University Hannover
state: Lower Saxony
city: Düsseldorf
country: Germany
facility: University Clinic Düsseldorf
state: North Rhine-Westphalia
city: Essen
country: Germany
facility: Kliniken Essen Mitte, Essen
state: North Rhine-Westphalia
city: Herne
country: Germany
facility: Rheumazentrum Ruhrgebiet Herne, Ruhr University Bochum
state: North Rhine-Westphalia
city: Münster
country: Germany
facility: University Clinic Münster
state: North-Rhine Westphalia
city: Mainz
country: Germany
facility: University Clinic Mainz
state: Rhineland Palatinate
city: Dresden
country: Germany
facility: University Medical Center TU Dresden
state: Sachsen
city: Berlin
country: Germany
facility: Charité - Berlin University of Medicine
city: Kiel
country: Germany
facility: UKSH Campus Kiel
Study officials:
affiliation: Heinrich-Heine University, Duesseldorf
name: Matthias Schneider, MD
role: PRINCIPAL_INVESTIGATOR
References: