LUPUS-BEST - Treat-to-target in Systemic Lupus Erythematosus (Lupus-Best)

Heinrich-Heine University, Duesseldorf

Status: Enrolling

Conditions: Systemic Lupus Erythematosus

Treatments: Other: Treat-to-target as a new treatment concept

Study type: Interventional

Funder types: Other

Identifiers

NCT05714930

LUPUS-BEST

Details and patient eligibility

About

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.

Full 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.

Enrollment: 606 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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606 participants in 2 patient groups

Treat-to-target

Experimental group

Description:

T2T will be implemented based on shared decision-making (SDM), tight control and remission as a validated treatment target (disease activity score clinical SLEDAI-2k = 0 \& glucocorticoids (GC) ≤ 5 mg prednisolone equivalent \& physician global assessment (PGA 0-3) \< 0.5 ± immunomodulatory therapy); All intervention centers will receive T2T/SDM trainings. Patients not meeting their target criterion at study entry or at any time during the trial will be included in a tight control T2T loop of 24 weeks with assessments every 6 weeks to reach the target by adjustments of their immunomodulatory treatments. Patients in target will be assessed every 12 weeks as it is standard in clinical routine care.

Treatment:

Other: Treat-to-target as a new treatment concept

Standard of Care

No Intervention group

Description:

In the standard of care (SoC) arm, patients receive 3-to 6-monthly controls and treatment adjustments according to their physician's discretion.