Idiopathic Inflammatory Myopathies
Conditions
Keywords
Dermatomyositis, Immunomodulation, Immunosuppressive agents, Myositis, Polymyositis, Necrotizing myopathies, Antisynthetase syndrome
Brief summary
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.
Detailed description
To compare two groups of patients as described in Brief Summary.
Interventions
DRUGIntravenous Infusion
Intravenous infusion of follow medicine at disease onset: methyprednisolone and/or human intravenous immunoglobulin
Sponsors
University of Sao Paulo
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Idiopathic inflammatory myopathies
Exclusion criteria
* Inclusion body myositis, muscular dystrophies, neoplasia-associated myopathies, overlapped myopathies, others myopathies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Manual Muscle Testing | Six months | 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. |
| Physician Global Activity | Six months | 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. |
| Patient/Parent Global Activity - | Six months | 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. |
| Myositis Disease Activity Assessment Tool | Six months | 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) |
| Health Assessment Questionnaire | Six months | Define the health assessement questionnaire. Pontuaction: 0.00-3.00 |
| Muscle Enzymes | Six months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side effects to treatment (glucocorticoid, immunosuppressants and/or human intravenous immunoglobulin) | Six months | Effect of drugs in disease outcomes |
Countries
Brazil
Contacts
Primary ContactSamuel K Shinjo, PhD
Outcome results
None listed