Optimizing Treatment on Idiopathic Inflammatory Myopathies

Sponsor

University of Sao Paulo (Other)

Overall Status

Recruiting

CT.gov ID

NCT03092180

Collaborator

(none)

Enrollment

Location

208.9

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Inflammatory Myopathies	Drug: Intravenous Infusion

Detailed Description

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Optimizing Treatment on Idiopathic Inflammatory Myopathies

Study Start Date :

Jan 1, 2005

Actual Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

May 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Idiopathic inflammatory myopathies 1 Intravenous infusion with methyprednisolone / human intravenous immunoglobulin at disease onset	Drug: Intravenous Infusion Intravenous infusion of follow medicine at disease onset: methyprednisolone and/or human intravenous immunoglobulin Other Names: Medicine
Idiopathic inflammatory myopathies 2 Intravenous infusion with methyprednisolone at disease onset	Drug: Intravenous Infusion Intravenous infusion of follow medicine at disease onset: methyprednisolone and/or human intravenous immunoglobulin Other Names: Medicine

Arm

Intervention/Treatment

Idiopathic inflammatory myopathies 1

Intravenous infusion with methyprednisolone / human intravenous immunoglobulin at disease onset

Drug: Intravenous Infusion

Intravenous infusion of follow medicine at disease onset: methyprednisolone and/or human intravenous immunoglobulin

Other Names:

Medicine

Idiopathic inflammatory myopathies 2

Intravenous infusion with methyprednisolone at disease onset

Drug: Intravenous Infusion

Intravenous infusion of follow medicine at disease onset: methyprednisolone and/or human intravenous immunoglobulin

Other Names:

Medicine

Outcome Measures

Primary Outcome Measures

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.
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.
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.
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)

Secondary Outcome Measures

Side effects to treatment (glucocorticoid, immunosuppressants and/or human intravenous immunoglobulin) [Six months]
Effect of drugs in disease outcomes