Actively Recruiting

Age: 18Years +
All Genders
NCT06051773

Evaluation of Muscle Involvement in Systemic Sclerosis

Led by Central Hospital, Nancy, France · Updated on 2024-08-27

150

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Evaluation of Muscle Involvement in Systemic Sclerosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with systemic sclerosis according to 2013 ACR/EULAR classification criteria
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

Paul Decker

Nancy, France

Actively Recruiting

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Research Team

P

Paul Decker, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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