Systemic SclerosisMUSScNCT06051773
Evaluation of Muscle Involvement in Systemic Sclerosis
An observational study of Systemic Sclerosis, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- muscle involvement
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with systemic sclerosis
Who may be able to join
- Patients with systemic sclerosis according to 2013 ACR/EULAR classification criteria
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Paul Decker
Nancy
Paul Decker, +33383157240, p.decker@chru-nancy.fr
About this study
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.
Read more
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
- Being tested
- muscle involvement
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
muscle involvementOther
evaluation of muscle involvement
| Study group | Role | What they receive |
|---|---|---|
| SSc patients | Not described Receives: Other: muscle involvement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline (J0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start1 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul DECKER, MD, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051773
- Sponsor's protocol ID
- 2023PI160
- Acronym
- MUSSc
- Status last verified
- Aug 2024
- First submitted
- 13 Sep 2023
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Muscle Involvement in Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT06051773
- Acronym / sponsor ID
- MUSSc / 2023PI160
- Conditions
- Systemic Sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SSc patients | – | Other: muscle involvement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with systemic sclerosis
Key inclusion criteria (1 listed)
- Patients with systemic sclerosis according to 2013 ACR/EULAR classification criteria
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| muscle involvementevaluation of muscle involvement | Other | SSc patients |
Primary outcome
Number of patients with muscle involvement
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Decker, MD (+33383157240, p.decker@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with muscle involvement (time frame: baseline (J0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.