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Evaluation of Muscle Involvement in Systemic Sclerosis

Evaluation of Muscle Involvement in Systemic Sclerosis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06051773
Acronym
MUSSc
Enrollment
150
Registered
2023-09-25
Start date
2024-01-01
Completion date
2024-12-31
Last updated
2024-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Sclerosis

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

Interventions

OTHERmuscle involvement

evaluation of muscle involvement

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with muscle involvementbaseline (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

Countries

France

Contacts

Primary ContactPaul Decker, MD
p.decker@chru-nancy.fr+33383157240

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026