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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Idiopathic inflammatory myopathies 1 | Intravenous infusion with methyprednisolone / human intravenous immunoglobulin at disease onset |
| |
| Idiopathic inflammatory myopathies 2 | Intravenous infusion with methyprednisolone at disease onset |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Infusion | Drug | Intravenous infusion of follow medicine at disease onset: methyprednisolone and/or human intravenous immunoglobulin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physician 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. | 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. | 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. | Six months |
| Health Assessment Questionnaire | Define the health assessement questionnaire. Pontuaction: 0.00-3.00 | 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects to treatment (glucocorticoid, immunosuppressants and/or human intravenous immunoglobulin) | Effect of drugs in disease outcomes | Six months |
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Inclusion Criteria:
Exclusion Criteria:
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Idiopathic inflammatory myopathies
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samuel K Shinjo, PhD | Contact | 55-11-3061-7176 | samuel.shinjo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Samuel K Shinjo, PhD | Universidade de Sao Paulo - Rheumatology Division | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samuel Katsuyuki Shinjo | Recruiting | São Paulo | 01246903 | Brazil |
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| ID | Term |
|---|---|
| D009220 | Myositis |
| D003882 | Dermatomyositis |
| D017285 | Polymyositis |
| C537778 | Antisynthetase syndrome |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D007262 | Infusions, Intravenous |
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D061605 | Administration, Intravenous |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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Serum and muscle biopsies
NOTE: This is a observational study. Subjects in the study will receive a routine care that has been established in our Instituition (diagnostic, therapeutic, biospecimen analysis and retention).
|
| Six months |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D007263 |
| Infusions, Parenteral |
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |