Clinical trial: A Study of Ustekinumab in Participants With Active Polymyositis and Dermatomyositis Who Have Not Adequately Responded to One or More Standard-of-care Treatments (NCT03981744)

Eligibility criteria:
Inclusion Criteria:

          -  Has a diagnosis of polymyositis (PM)/ dermatomyositis (DM) made or confirmed by a
             physician (such as a rheumatologist, neurologist, or dermatologist) experienced in
             treatment of PM/DM at least 6 weeks prior to first dose of the study drug

          -  Has PM or DM which is considered active despite receiving at least 1 standard-of-care
             treatment by the investigator

          -  Must be receiving 1 or more of the following protocol-permitted, systemic
             standard-of-care treatments: i) glucocorticoids, ii) 1 or 2 of the following
             immunomodulatory drugs: mycophenolate mofetil, azathioprine, oral methotrexate, oral
             tacrolimus, or oral cyclosporine A

          -  Regular or as needed treatment with topical use of glucocorticoids are permitted to
             treat skin lesions on a stable dose for greater than or equal to (>=) 2 weeks prior to
             first dose of the study drug

          -  Contraceptive (birth control) use by men or women should be consistent with local
             regulations regarding the acceptable methods of contraception for those participating
             in clinical studies

          -  Must be medically stable on the basis of clinical laboratory tests performed at
             screening. If the results of the clinical laboratory tests are outside the normal
             reference ranges, the participant may be included only if the investigator judges the
             abnormalities or deviations from normal to be not clinically significant

          -  Demonstrable muscle weakness at screening and Week 0 measured by the Manual Muscle
             Testing (MMT)-8 less than or equal to (<=)135 units

          -  Demonstrable muscle weakness at screening measured by any 2 or more of the followings:
             (i) PhGA greater than or equal to (>=) 1.5 centimeter (cm), (ii) 1 or more muscle
             enzymes (Creatine kinase [CK], and aldolase) >=1.4*upper limit of normal (ULN), (iii)
             Myositis disease activity assessment tool (MDAAT)-Extramuscular Global Assessment
             >=1.5 cm

        Exclusion Criteria:

          -  Has myositis other than PM/DM, including but not limited to amyopathic dermatomyositis
             (ADM), clinically amyopathic DM, juvenile DM, inclusion body myositis (IBM)
             immune-mediated necrotizing myopathy diagnosed based on muscle biopsy findings and
             positive anti-SRP or anti-HMGCR antibody, drug-induced myositis, PM associated with
             human immunodeficiency virus (HIV), and muscular dystrophy, congenital myopathy,
             metabolic myopathy, and mitochondrial myopathy

          -  Has other inflammatory diseases that might confound the evaluations of efficacy,
             including but not limited to rheumatoid arthritis (RA), psoriatic arthritis (PsA),
             systemic lupus erythematosus (SLE), psoriasis, or Crohn's disease

          -  Has severe respiratory muscle weakness confirmed by the investigator based on the
             consultation with a pulmonologist and the measures of respiratory muscle strength such
             as maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) and/or
             maximal voluntary ventilation (MVV) measurements and lung capacity such as forced
             vital capacity (FVC). The results need to be within population appropriate normal
             limits

          -  Has severe muscle damage (Myositis Damage Index-VAS [Muscle Damage] greater than (>) 7
             centimeter [cm]), permanent weakness due to a non-IIM cause, or myositis with cardiac
             dysfunction

          -  Has glucocorticoid-induced myopathy which the investigator considers the primary cause
             of muscle weakness

          -  Has positive test result of anti-melanoma differentiation-associated protein 5 (MDA5)
             antibody (anti clinically amyopathic dermatomyositis (C-ADM)-140 antibody).

          -  Has had a nontuberculous mycobacterial infection or opportunistic infection

          -  Has a history of, or ongoing, chronic or recurrent infectious disease

          -  Has past history of severe Interstitial lung disease (ILD) flare, severe
             non-infectious lung inflammation which required active intervention, or multiple
             relapses of these conditions

          -  Presence or history of malignancy within 5 years before screening
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.
Subject must be at most 75 Years

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? Contradiction