As a T2T, our patients with idiopathic inflammatory myopathies will receive pulse therapies with methyprednisolone and/or human intravenous immunoglobulin, or only methyprednisolone at disease onset. This scheme is an internal routine protocol of our Service.
To compare two groups of patients as described in Brief Summary.
Study Type
OBSERVATIONAL
Enrollment
60
Intravenous infusion of follow medicine at disease onset: methyprednisolone and/or human intravenous immunoglobulin
Samuel Katsuyuki Shinjo
São Paulo, Brazil
RECRUITINGPhysician Global Activity
This partially validated tool measures the global evaluation by the treating physician of the overall disease activity of the patient at the time of assessment using a 10 cm. visual analogue scale and a 5 point Likert scale.
Time frame: Six months
Patient/Parent Global Activity -
This partially validated tool measures the global evaluation by the patient, or by the parent if the patient is a minor, of the patient's overall disease activity at the time of assessment using a 10 cm. visual analogue scale.
Time frame: Six months
Manual Muscle Testing
This partially validated tool assesses muscle strength using manual muscle testing (MMT). A 0 - 10 point scale is proposed for use. An abbreviated group of 8 proximal, distal, and axial muscles performs similarly to a total of 24 muscle groups, and is also proposed for use for research studies.
Time frame: Six months
Health Assessment Questionnaire
Define the health assessement questionnaire. Pontuaction: 0.00-3.00
Time frame: Six months
Muscle Enzymes
This partially validated tool measures the serum activities of at least 2 of the 4 muscle-associated enzymes including creatine phosphokinase (CK), the transaminases (ALT, AST), lactate dehydrogenase (LD) and aldolase.
Time frame: Six months
Myositis Disease Activity Assessment Tool
After local anesthesia, a cutaneous incision will be made in lateral thigh face. The biopsy will be done using the Bergstrom needle. Histological (hematoxylin and eosin)/immunohistochemical (CD4, CD8, CD68, CD20, C5b-9, MHCI, MHCII, CD31) analysis will be performed in muscle samples (at baseline and after 12 weeks) in all patients (present study)
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Time frame: Six months
Side effects to treatment (glucocorticoid, immunosuppressants and/or human intravenous immunoglobulin)
Effect of drugs in disease outcomes
Time frame: Six months