Clinical trial: Exercise Capacity of Patients With Dermatomyosis (NCT03293615)

Eligibility criteria:
Inclusion Criteria:

          -  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 Criteria:

          -  - 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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 50-year-old woman comes to the clinic complaining of difficulty swallowing both liquids and solid foods, as well as occasional cough while eating.  She also has difficulty lifting her arms above her head and getting up from a chair. The weakness seems to get worse gradually. The patient has no prior medical problems and takes no medications.  Vital signs are normal.  Physical examination shows an erythematous rash on the upper eyelids. There are some red papules over joints of her hands. The rest of the physical examination is unremarkable. Antinuclear antibodies, anti-Jo-1 antibodies and anti-MDA5 antibody are positive.  Muscle biopsy shows perifascicular inflammation and atrophy of the fascicle and surrounding blood vessels.

Patient description (patient's own words): I had to go to the clinic because of difficulty swallowing all kinds of food, liquid and solid. I also sometimes cough when I eat my dinner. At only 50 year old, I had some difficulties lifting up my arms and getting up from a chair! And it's only getting worse! I never had any medical issues in the past and I'm not under any medication, I just don't get it! My vitals were normal. The physical exam showed a red rash on my upper eyelids. I also have red papules on my hands' joints. After a blood test, they told me that my antinuclear antibodies, anti-Jo-1 antibodies, and anti-MDA5 antibodies were positive.  I also did a muscle biopsy and it showed that I had an atrophy of my blood vessels around my muscle fibers and that I have an inflammation of these.

Does the patient match the trial criteria? Entailment