Comparison of the Clinical Examination and the Joint Ultrasonography in the Evaluation of Disease Activity in Systemic Lupus Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 7
- 主要终点
- Clinical joint assessment (synovitis / tenosynovitis / effusion)
研究概览
简要总结
Arthritis is a current manifestation of systemic lupus erythematosus (SLE) and participates to the SLEDAI composite score calculation (0 to 105). Ultrasonography (US) is a validated and sensitive tool for joint assessment. Published studies showed US joint abnormalities in systemic lupus erythematosus patients with or without joint pain. Nevertheless, ultrasonography evaluations were not standardized and no study compared clinical and ultrasonography assessments. The objectives were 1) to describe ultrasonography joint abnormalities in systemic lupus erythematosus population, 2) to compare clinical and ultrasonography standardized joint assessments, 3) to estimate the reliability of clinical swollen joint count (C-SJC) and SLEDAI (C-SLEDAI) score versus ultrasonography-SJC and ultrasonography-SLEDAI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Systemic Lupus Erythematosus patients (with or without joint involvement).
- •subjects will have to sign the inform consent before the beginning of the study
排除标准
- •Current pregnancy or no effective contraception
研究组 & 干预措施
Ultrasonography
B-mode and power Doppler Ultrasonography examination
干预措施: Ultrasonography (Other)
结局指标
主要结局
Clinical joint assessment (synovitis / tenosynovitis / effusion)
时间窗: Day 0
Ultrasonography record (synovitis / tenosynovitis / effusion)
时间窗: Day 0 (there is only one point measurement in the study)
Evaluate SELENA SLEDAI (C-SLEDAI) score
时间窗: Day 0
Evaluate musculoskeletal BILAG score
时间窗: Day 0
次要结局
未报告次要终点