LUMIER² Study : LUpus Molecular Immunomonitoring to Evaluate the Risk of Relapse
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Area under the curve of the blood transcriptomic score to predict SLE flares.
研究概览
简要总结
We aim to determine the accuracy or blood transcriptomic signatures to predict the occurrence of flares in patients with SLE that are clinically quiescent at inclusion Systemic Lupus Erythematosus (SLE) is a chronic auto-immune disease evolving by flares, with possible organ damage, and periods of remission. Current biological markers of disease activity are not sufficient to predict the occurrence of flares, monitor response to treatment or adapt therapeutic strategies. A previous study on genome-wide whole blood transcriptomic signatures in SLE (Chiche et al, Arthritis Rheumatology 2014) has identified gene panels associated with SLE disease activity
详细描述
Systemic Lupus Erythematosus (SLE) is a chronic auto-immune disease evolving by flares, with possible organ damage, and periods of remission. Current biological markers of disease activity are not sufficient to predict the occurrence of flares, monitor response to treatment or adapt therapeutic strategies. A previous study on genome-wide whole blood transcriptomic signatures in SLE (Chiche et al, Arthritis Rheumatology 2014) has identified gene panels associated with SLE disease activity.
We aim to determine the accuracy or blood transcriptomic signatures to predict the occurrence of flares in patients with SLE that are clinically quiescent at inclusion.
LUMIER² is a prospective multicentric observational study conducted in the departments of Clinical Nephrology, Internal Medicine and Rheumatology in the South of France. Adult patients with SLE, clinically quiescent and with no change in treatment in the past 3 months, will be included and followed-up for 12 months. Blood samples will be drawn every 3 months during 12 months in the absence of flare. Patients presenting a flare will be sampled at the time of the flare and 1 month later.
The inclusion of 300 patients is expected, with a test cohort (150 patients) and a validation cohort (150 patients).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •SLE defined by ACR criteria
- •Clinically quiescent disease (SLEDAI =< 4 without clinical flare) and absence of treatment increase in the past 3 months
- •Written informed consent
排除标准
- •Pregnancy, lactation
结局指标
主要结局
Area under the curve of the blood transcriptomic score to predict SLE flares.
时间窗: 3 months
次要结局
未报告次要终点
