Evaluation of Muscle Involvement in Systemic Sclerosis

NCT06051773 | Recruiting

• 1 other identifier: 2023PI160
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

SSc patients

Other: muscle involvement

Interventions

muscle involvement OTHER

evaluation of muscle involvement

SSc patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with systemic sclerosis

You may qualify if:

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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Paul Decker

Nancy, France

RECRUITING

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Paul Decker, MD

CONTACT

+33383157240; p.decker@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 25, 2023
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)