跳至主要内容
临床试验/NCT06051773
NCT06051773
招募中
不适用

Evaluation of Muscle Involvement in Systemic Sclerosis

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 150 人2024年1月1日

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
注册库
clinicaltrials.gov
开始日期
2024年1月1日
结束日期
2024年12月31日
最后更新
去年
研究类型
Observational
性别
All

研究者

发起方
Central Hospital, Nancy, France
责任方
Principal Investigator
主要研究者

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

研究点 (1)

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