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Optimizing Treatment on Idiopathic Inflammatory Myopathies

NCT ID: NCT03092180

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Study Completion Date

2024-12-04

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.

Conditions

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Idiopathic Inflammatory Myopathies

Keywords

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Dermatomyositis Immunomodulation Immunosuppressive agents Myositis Polymyositis Necrotizing myopathies Antisynthetase syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Idiopathic inflammatory myopathies 1

Intravenous infusion with methyprednisolone / human intravenous immunoglobulin at disease onset

Intravenous Infusion

Intervention Type DRUG

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

Idiopathic inflammatory myopathies 2

Intravenous infusion with methyprednisolone at disease onset

Intravenous Infusion

Intervention Type DRUG

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

Interventions

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Intravenous Infusion

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

Intervention Type DRUG

Other Intervention Names

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Medicine

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Samuel Katsuyuki Shinjo, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samuel K Shinjo, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade de Sao Paulo - Rheumatology Division

Locations

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Samuel Katsuyuki Shinjo

São Paulo, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Samuel K Shinjo, PhD

Role: CONTACT

Phone: 55-11-3061-7176

Email: [email protected]

Other Identifiers

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MYO-HCFMUSP-01

Identifier Type: -

Identifier Source: org_study_id