LUPUS-BEST - Treat-to-target in Systemic Lupus Erythematosus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Treat-to-target as a new treatment concept.
- Who it may be relevant to
- Registry conditions: Systemic Lupus Erythematosus. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
LUPUS-BEST - Treat-to-target in Systemic Lupus Erythematosus. A Multicenter Two-armed Cluster-randomized Controlled Trial
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.
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.
Interventions
- Other Treat-to-target as a new treatment concept
After 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. Pharmace
Primary outcome measures
- Damage accrual [Time frame: week 120]
Secondary outcome measures (12)
- Health Related Quality of Life (HRQoL) [Time frame: week 120]
- Disease activity reported by physicians [Time frame: week 120]
- Patient-reported disease activity [Time frame: week 120]
- Cumulative time in remission [Time frame: 120 weeks]
- Cumulative number of new organ manifestations [Time frame: 120 weeks]
- Time to achieve remission [Time frame: 120 weeks]
- Cumulative glucocorticoid (GC) dosage at week 120 [Time frame: week 120]
- Percentage of patients refusing remission as target [Time frame: 120 weeks]
- Percentage of physicians refusing remission as target [Time frame: 120 weeks]
- Drug adherence [Time frame: 120 weeks]
- Fatigue [Time frame: 120 weeks]
- Fatigue [Time frame: 120 weeks]
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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 14 centers
- University Clinic Freiburg — Freiburg im Breisgau
- University Clinic Heidelberg — Heidelberg
- University Clinic Erlangen — Erlangen
- LMU Munich — Munich
- University Clinic Frankfurt — Frankfurt am Main
- Medical University Hannover — Hanover
- University Clinic Düsseldorf — Düsseldorf
- Kliniken Essen Mitte, Essen — Essen
- … and 6 more centers
Identifiers
NCT: NCT05714930 · LUPUS-BEST