Evaluation of Muscle Involvement in Systemic Sclerosis
- Conditions
- Systemic Sclerosis
- Interventions
- Other: muscle involvement
- Registration Number
- NCT06051773
- Lead Sponsor
- Central Hospital, Nancy, France
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- Patients with systemic sclerosis according to 2013 ACR/EULAR classification criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description SSc patients muscle involvement -
- Primary Outcome Measures
Name Time Method Number of patients with muscle involvement 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Paul Decker
🇫🇷Nancy, France