跳至主要内容
临床试验/NCT01772069
NCT01772069已完成不适用

Health-Related Quality of Life in Patients With Systemic Lupus Erythematosus:Focusing on Fibromyalgia

The Catholic University of Korea0 个研究点目标入组 300 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
主要终点
EuroQoL (EQ-5D)

研究概览

简要总结

Systemic lupus erythematosus (SLE) patients show a high prevalence of fibromyalgia though rates vary considerably from one study to another (from 8.2% to 45%). Although fibromyalgia can bring out the disability in daily life, the majority of previous reports only ascertained no significant association between the presence of fibromyalgia and the severity of SLE.

It is necessary to make unremitting effort to reduce the mortality and life-threatening disease flare-up due to SLE disease itself. Additionally, we think that physicians need to pay more attention to improve health-related quality of life (HRQoL) in the patients with SLE. HRQoL could be influenced by various factors such as depression, fibromyalgia, disease duration, disease activity and etc. To improve the HRQoL in SLE patients, it might be the clinically important and constructive theme to investigate that which is the most important factor among the fibromyalgia, depression, sleep quality, SLE activity and SLE duration.

The objective of this study is to evaluate the degree of contribution of fibromyalgia for reduced HRQoL and to identify the status of managing fibromyalgia in Korean patients with SLE.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Woman between 30 and 60 years of age, inclusive
  • Have a diagnosis of Systemic lupus erythematosus according to the 1997 updated American college of Rheumatology criteria for classification of systemic lupus erythematosus

排除标准

  • Patients were excluded if they had had a history of head injury that led to unconsciousness
  • Have unstable disease necessitating an increase in prednisone dose or the addition of another immunosuppressive medication
  • Have a current malignancy
  • Have a history of or current evidence of substance abuse (drug or alcohol) problem within the previous 2 years

结局指标

主要结局

EuroQoL (EQ-5D)

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jun-Ki Min

Professor

The Catholic University of Korea

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