Clinical trial: Methimazole to Treat Polymyositis and Dermatomyositis (NCT00001421)

Eligibility criteria:
Diagnosis of Polymyositis or Dermatomyositis.

        Baseline muscle weakness score of less than or equal to 139 out of 160 on manual testing
        (MMT).

        Baseline functional assessment score of less than or equal to 82 out of 91.

        Ability to provide informed consent to all aspects of the study after full information is
        provided.

        Age equal to or older than 18.

        A diagnosis of classic or definite polymyositis or dermatomyositis (Critieria A and B plus
        at least one of the three other criteria):

          1. Symmetrical proximal muscle weakness;

          2. Muscle biopsy abnormalities at some time during their disease:

        i. degeneration and regeneration of muscle fibers

        ii. necrosis

        iii. phagocytosis

        iv. interstitial mononuclear infiltration;

        c. Elevation of serum creatinine phosphokinase (CPK), transaminases, lactic dehydrogenase
        (LDH) or aldolase activity;

        d. Electromyography (EMG) triad of changes

        i. small amplitude, short duration polyphasic motor unit potentials

        ii. fibrillations, positive sharp waves, increased insertional irritability

        iii. spontaneous bizarre high frequency discharges;

        e. Typical skin rash of DM.

        Willingness to undergo 2 muscle biopsies.

        Evidence of active disease as measured by weakness, and an elevated CK or an active MRI.

        Must be tapered to a stable dose of steroid equal to or less than 0.50 mg/kg/day equivalent
        of prednisone for one month prior to the study.

        If on additional immunosuppressive drugs, the drugs must be maintained at a stable dose for
        1 month prior to the initiation of therapy and will be maintained throughout the trial.

        Women of childbearing potential and men whose partners are of childbearing potential must
        practice an acceptable form of contraception. No pregnant females or nursing mothers.

        No history of hepatitis or abnormal liver function tests.

        No history of prior thyroid disease.

        No active acute or chronic infections requiring antimicrobial therapy, or serious viral or
        fungal infections.

        No preexisting or coexisting malignancy other than basal cell and localized squamous cell
        carcinoma of the skin.

        No history of cerebrovascular accidents, seizure disorder, aseptic meningitis, transverse
        myelitis or central nervous system disease.

        No history of documented coronary artery disease, cardiomyopathy, greater than first-degree
        heart block, or dysrhythmia requiring therapy.

        No confounding medical illness that in the judgement of the investigators would pose added
        risk for study participants.

        No anemia requiring maintenance blood transfusions; leukoplakia with WBC less than 3,000
        micrograms or absolute neutrophil count less than 2,000 micrograms; and platelet count less
        than 100,000 micrograms on at least two different occasions.

        No history of (or current) autoimmune hemolytic anemia.

        No current anticoagulant therapy.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.



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