MUSSc: Evaluation of Muscle Involvement in Systemic Sclerosis

Sponsor

Central Hospital, Nancy, France (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06051773

Collaborator

(none)

150

Enrollment

Location

Anticipated Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Systemic Sclerosis	Other: muscle involvement

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Evaluation of Muscle Involvement in Systemic Sclerosis

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
SSc patients	Other: muscle involvement evaluation of muscle involvement

Arm

Intervention/Treatment

SSc patients

Other: muscle involvement

evaluation of muscle involvement

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Paul Decker	Nancy		France

Sponsors and Collaborators

Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Paul DECKER, MD, Principal Investigator, Central Hospital, Nancy, France

ClinicalTrials.gov Identifier:

NCT06051773

Other Study ID Numbers:

2023PI160

First Posted:

Sep 25, 2023

Last Update Posted:

Sep 25, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Scleroderma, Systemic

Scleroderma, Diffuse

Sclerosis

Study Results

No Results Posted as of Sep 25, 2023