Overview
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.
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
Inclusion Criteria:
- 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
- GC dosage above 5 mg prednisone equivalent per day AND/OR
- 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