LUPUS-BEST - Treat-to-target in Systemic Lupus Erythematosus

Официальное название

LUPUS-BEST - Treat-to-target in Systemic Lupus Erythematosus. A Multicenter Two-armed Cluster-randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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

Первичные конечные точки

• Damage accrual [Срок оценки: week 120]

Вторичные конечные точки (12)

• Health Related Quality of Life (HRQoL) [Срок оценки: week 120]
• Disease activity reported by physicians [Срок оценки: week 120]
• Patient-reported disease activity [Срок оценки: week 120]
• Cumulative time in remission [Срок оценки: 120 weeks]
• Cumulative number of new organ manifestations [Срок оценки: 120 weeks]
• Time to achieve remission [Срок оценки: 120 weeks]
• Cumulative glucocorticoid (GC) dosage at week 120 [Срок оценки: week 120]
• Percentage of patients refusing remission as target [Срок оценки: 120 weeks]
• Percentage of physicians refusing remission as target [Срок оценки: 120 weeks]
• Drug adherence [Срок оценки: 120 weeks]
• Fatigue [Срок оценки: 120 weeks]
• Fatigue [Срок оценки: 120 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 14 центров

• 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
• … и ещё 6 центров

Идентификаторы

NCT: NCT05714930 · LUPUS-BEST

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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