Clinical trial: Safety and Effectiveness of h5G1.1-mAb for Dermatomyositis (NCT00005571)

Eligibility criteria:
Patients age greater than or equal to 18 years.

        Patients with a diagnosis of definite or probable dermatomyositis by criteria of Bohan et.
        al., with either active rash typical of dermatomyositis, history of rash typical of
        dermatomyositis, or Gottron's papules.

        Patients with a manual muscle testing score less than or equal to 136/170.

        Patients with a disease duration greater than or equal to 6 months.

        Patients with persistent disease (defined as active rash plus CK greater than or equal to 2
        times ULN), or rapidly progressive disease, or response to steroids with inability to taper
        dose, or unacceptable side effects of steroids.

        Patients may be on stable (times 28 days prior to Visit 2) dose of MTX or AZA.

        No other immunosuppressive agents times 84 days prior to first dose.

        Patients on stable oral steroid use for 28 days prior to Visit 2.

        Patients with adequate hematologic function, defined as hemoglobin greater than or equal to
        8.5 g/dl, WBC greater than or equal to 3,000 mm(3), neutrophils greater than or equal to
        1,200 mm(3), platelets greater than or equal to 100,000 mm(3).

        Patients must be willing and able to give informed consent.

        Women must be post-menopausal, surgically sterile or practicing a medically approved method
        of contraception.

        Patients with liver disease will be excluded.

        Patients with history of alcohol or drug abuse within two years of screening, or a history
        of positive Hepatitis B or Hepatitis C serology, unless vaccinated will be excluded.

        Patients with renal insufficiency, defined as creatinine greater than or equal to 2.0 mg/dl
        will be excluded.

        Patients with history of malignancy, except basal cell carcinoma and remote (greater than
        or equal to 5 years) malignancies in complete remission will be excluded.

        Patients with history of poorly controlled diabetes will be excluded.

        Patients with presence or suspicion of active infection, recent serious infection, or
        chronic/recurrent viral or bacterial infection will be excluded.

        Patients with throat culture positive for pathogenic Neisseria species (meningitidis or
        gonorrhoeae) will be exluded. Subjects with a positive culture may be treated with
        appropriate antibiotic therapy and retested.

        Patients with joint disease or replacement that would interfere with patient's ability to
        perform muscle testing will be excluded.

        Patients with any clinically significant medical condition that is likely to interfere with
        the participation in the study or the evaluation of the study medication's safety profile
        will be excluded.

        No patients with known or suspected hereditary complement deficiency will be excluded.

        Patients with history of allergic reaction to murine proteins will be excluded.

        Patients participating in any other investigational drug trial, or exposure to other
        investigational agent or device within thirty days prior to screening will be excluded.

        Pregnant or breastfeeding patients will be excluded.

        Women intending to conceive during the course of the study, including follow-up period will
        be excluded.

        Patients with history of HIV, Lyme disease, or other environmentally induced myositis will
        be excluded.
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