Status:
TERMINATED
Exercise Capacity of Patients with Dermatomyosis
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Dermatomyositis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Dermatomyositis (DM) patients experience muscle weakness and low aerobic capacities, which are associated with poor health status and increased mortality. The origin of this muscle impairment remains ...
Eligibility Criteria
Inclusion
- Woman or man\> 18 years,
- Signature of informed consent,
- Muscle biopsy for suspicion of recent inflammatory myopathy (\<6 months) or for exclusion of neuromuscular pathology.
- Prospectively, following the results of the muscle biopsy, the subjects will divided into three groups meeting the following criteria:
- "DM" group: DM according to the ENMC criteria;
- "other inflammatory myopathy" group: polymyositis, autoimmune necrotizing myopathy, non-specific myositis or inclusion myositis according to the ENMC criteria;
- Group "no neuromuscular pathology": i) myalgia and / or intolerance to exercise and ii) normal neuromuscular examination, iii) no increase in blood creatine kinase level, iv) absence of electromyographic abnormality, v) histological Muscle mass.
Exclusion
- \- Taking an immunomodulatory treatment within 6 months before inclusion,
- Paraneoplastic form of the disease,
- Presence of associated interstitial pneumonitis,
- Neuromuscular pathology different from inflammatory myopathy,
- Unbalanced cardiovascular disease,
- Impossibility of giving the subject informed information (subject in an emergency situation, difficulty in understanding the subject, ...),
- Subject under safeguard of justice,
- Subject under tutelage or under curators,
- Pregnancy (positive pregnancy test)
- Breastfeeding.
Key Trial Info
Start Date :
November 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2024
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03293615
Start Date
November 28 2019
End Date
September 1 2024
Last Update
September 19 2024
Active Locations (1)
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1
Meyer
Strasbourg, France, 67000