Evaluation of Muscle Involvement in Systemic Sclerosis
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Systemic Sclerosis
- 发起方
- Central Hospital, Nancy, France
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of patients with muscle involvement
- 状态
- 招募中
- 最后更新
- 去年
概览
简要总结
Muscle involvement is poorly described in patients with systemic sclerosis (SSc) .
The prevalence of muscle damage is evaluated at 5-95 % of SSc patients, particularly due to variable definitions depending on the series in the scientific litterature. Muscle clinicobiological and histological presentation an response to immunosuppressive treatments are highly variable. Muscle involvement defined by creatinine kinase (CK) elevation, the presence of electromyography (EMG) abnormalities and/or muscle magnetic resonance imaging (MRI) hyperintensities and/or muscle biopsy inflammation appears to be associated with diffuse SSc, the presence of cardiac damage, and anti-PM-Scl antibodies.
The main objective is to describe muscular manifestations associated with SSc.
Secondary objectives are:
- to compare characteristics between SSc patients with and without muscle involvement
- to determine homogeneous groups of SSc patients with muscle involvement
研究者
Paul DECKER, MD
Principal Investigator
Central Hospital, Nancy, France
入排标准
入选标准
- •Patients with systemic sclerosis according to 2013 ACR/EULAR classification criteria
排除标准
- 未提供
结局指标
主要结局
Number of patients with muscle involvement
时间窗: baseline (J0)
Muscle involvement is defined by persistent CK elevation, and/or muscle MRI hyperintensities, and/or myogenic abnormalities on EMG, and/or presence of inflammatory myopathy on muscle biopsy