Evaluation of Muscle Involvement in Systemic Sclerosis

Systemic Sclerosis Clinical Trial

— MUSSc  

Official title:

Evaluation of Muscle Involvement in Systemic Sclerosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06051773
• Other study ID #: 2023PI160
• Status: Not yet recruiting
• Start date: January 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Central Hospital, Nancy, France
• Contact: Paul Decker, MD
• Phone: +33383157240
• Email: p.decker[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with systemic sclerosis according to 2013 ACR/EULAR classification criteria

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Other:
• muscle involvement
evaluation of muscle involvement

Locations

Country	Name	City	State
France	Paul Decker	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with muscle involvement	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	baseline (J0)