Optimizing Treatment on Idiopathic Inflammatory Myopathies

Study Overview
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Brief Summary
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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.

Detailed Description
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To compare two groups of patients as described in Brief Summary.

Official Title
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Optimizing Treatment on Idiopathic Inflammatory Myopathies

Conditions
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Idiopathic Inflammatory Myopathies

Intervention / Treatment
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* Drug: Intravenous Infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Idiopathic inflammatory myopathies Exclusion Criteria: Inclusion body myositis, muscular dystrophies, neoplasia-associated myopathies, overlapped myopathies, others myopathies

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Idiopathic inflammatory myopathies 1<br>Intravenous infusion with methyprednisolone / human intravenous immunoglobulin at disease onset | Drug: Intravenous Infusion<br>* Intravenous infusion of follow medicine at disease onset: methyprednisolone and/or human intravenous immunoglobulin<br>* Other names: Medicine;|
| Idiopathic inflammatory myopathies 2<br>Intravenous infusion with methyprednisolone at disease onset | Drug: Intravenous Infusion<br>* Intravenous infusion of follow medicine at disease onset: methyprednisolone and/or human intravenous immunoglobulin<br>* Other names: Medicine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects to treatment (glucocorticoid, immunosuppressants and/or human intravenous immunoglobulin) | Effect of drugs in disease outcomes | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dermatomyositis, Immunomodulation, Immunosuppressive agents, Myositis, Polymyositis, Necrotizing myopathies, Antisynthetase syndrome