LUPUS-BEST - Treat-to-target in Systemic Lupus Erythematosus. A Multicenter Two-armed Cluster-randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 606
- 试验地点
- 28
- 主要终点
- Damage accrual
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Standard of Care
In the standard of care (SoC) arm, patients receive 3-to 6-monthly controls and treatment adjustments according to their physician's discretion.
Treat-to-target
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.
干预措施: Treat-to-target as a new treatment concept (Other)
结局指标
主要结局
Damage accrual
时间窗: week 120
Damage is defined as irreversible disease associated damage, captured by the Systemic Lupus International Collaborating Clinics/ American College of Rheumatology (SLICC/ACR-) damage index (SDI). The SDI is a validated tool to assess irreversible damage that has occurred since onset of lupus. It ranges from 0 (no damage) to 44 (highest achievable damage and worst outcome). Primary endpoint is the difference of damage accrued over 120 weeks between the two arms after 120 weeks.
次要结局
- Time to achieve remission(120 weeks)
- Drug adherence(120 weeks)
- Evaluation of shared decision-making by physicians(120 weeks)
- Evaluation of health utilities(120 weeks)
- Cumulative glucocorticoid (GC) dosage at week 120(week 120)
- Percentage of patients refusing remission as target(120 weeks)
- Disease activity reported by physicians(week 120)
- Cumulative time in remission(120 weeks)
- Cumulative number of new organ manifestations(120 weeks)
- Health Related Quality of Life (HRQoL)(week 120)
- Patient-reported disease activity(week 120)
- Work productivity(120 weeks)
- Percentage of physicians refusing remission as target(120 weeks)
- Evaluation of shared decision-making (SDM) by patients(120 weeks)
- Fatigue(120 weeks)