Evaluation of Muscle Involvement in Systemic Sclerosis (MUSSc)

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

Study Overview

• Status: Recruiting
• Conditions: Systemic Sclerosis
• Intervention / Treatment: Other: muscle involvement

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Paul DECKER, MD; Phone Number: +33383157240; Email: p.decker@chru-nancy.fr

Study Locations

• France
  • Nancy, France
    • Recruiting
    • Paul Decker
    • Contact: Paul Decker; Phone Number: +33383157240; Email: p.decker@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with systemic sclerosis

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SSc patients	Other: muscle involvement; evaluation of muscle involvement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 13, 2023
• First Submitted That Met QC Criteria: September 21, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Connective Tissue Diseases; Sclerosis; Scleroderma, Systemic; Scleroderma, Diffuse
• Other Study ID Numbers: 2023PI160

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No