Evaluation of Muscle Involvement in Systemic Sclerosis

NCT ID: NCT06051773

Last Updated: 2024-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Systemic Sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SSc patients

muscle involvement

Intervention Type OTHER

evaluation of muscle involvement

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

muscle involvement

evaluation of muscle involvement

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Paul DECKER, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Paul Decker

Nancy, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Paul Decker, MD

Role: CONTACT

+33383157240

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Paul Decker

Role: primary

+33383157240

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023PI160

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Primary Sjögren Syndrome
NCT01989819 COMPLETED
Taking Charge of Systemic Sclerosis
NCT02494401 COMPLETED NA
Echo Systemic Sclerosis
NCT03143413 UNKNOWN