Optimizing Treatment on Idiopathic Inflammatory Myopathies

Recruiting

• Conditions: Idiopathic Inflammatory Myopathies
• Interventions: Drug: Intravenous Infusion

• Registration Number: NCT03092180
• Lead Sponsor: University of Sao Paulo

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2017-03-09
• Study First Submitted QC: 2017-03-21
• Study First Posted: 2017-03-27
• Primary Completion: 2024-05-06
• Status Verified: 2024-12
• Study Completion: 2024-12-04
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Idiopathic inflammatory myopathies

Read More

Exclusion Criteria

• Inclusion body myositis, muscular dystrophies, neoplasia-associated myopathies, overlapped myopathies, others myopathies

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Idiopathic inflammatory myopathies 1	Intravenous Infusion	Intravenous infusion with methyprednisolone / human intravenous immunoglobulin at disease onset
Idiopathic inflammatory myopathies 2	Intravenous Infusion	Intravenous infusion with methyprednisolone at disease onset

Primary Outcome Measures

Name	Time	Method
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)
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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Samuel Katsuyuki Shinjo; 🇧🇷 Sao Paulo, Brazil