跳至主要内容
临床试验/NCT02811094
NCT02811094终止不适用

LUMIER² Study : LUpus Molecular Immunomonitoring to Evaluate the Risk of Relapse

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2016年11月9日最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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