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Recruiting

NCT Number: NCT03092180

Optimizing Treatment on Idiopathic Inflammatory Myopathies

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Samuel Katsuyuki Shinjo

São Paulo, 01246903, Brazil

Location status: Recruiting

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Idiopathic inflammatory myopathies

Exclusion criteria

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

Treatment and study plan

Intravenous Infusion

Drug

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

Other names: Medicine

Primary outcomes

  1. Physician Global Activity

    Time frame: 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.

  2. Patient/Parent Global Activity -

    Time frame: 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.

  3. Manual Muscle Testing

    Time frame: 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.

  4. Health Assessment Questionnaire

    Time frame: Six months

    Define the health assessement questionnaire. Pontuaction: 0.00-3.00

  5. Muscle Enzymes

    Time frame: 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.

  6. Myositis Disease Activity Assessment Tool

    Time frame: 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 outcomes

  1. Side effects to treatment (glucocorticoid, immunosuppressants and/or human intravenous immunoglobulin)

    Time frame: Six months

    Effect of drugs in disease outcomes

Study contacts

Contact information is provided by the study sponsor or research team.

Samuel K Shinjo, PhD

CONTACT

[email protected]

55-11-3061-7176

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Important dates

Study start
2005
Primary completion
2024
Study completion
2024
First posted
Mar 27, 2017
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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