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Optimizing Treatment on Idiopathic Inflammatory Myopathies

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ClinicalTrials.gov Identifier: NCT03092180
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):

March 9, 2017
March 27, 2017
March 28, 2017
January 2005
January 2018   (Final data collection date for primary outcome measure)
  • 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.
  • 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.
  • 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.
  • Health Assessment Questionnaire [ Time Frame: Six months ]
    Define the health assessement questionnaire. Pontuaction: 0.00-3.00
  • 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.
  • 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)
  • Physician Global Activity - Visual Analogue Scale/Likert [ 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.
  • Patient/Parent Global Activity - Visual Analogue Scale/Likert [ 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.
  • Muscle Strength Testing - Manual Muscle Testing (MMT) [ 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.
  • Functional Assessment Tools - HAQ [ Time Frame: Six months ]
    Define the health assessement questionnaire. Pontuaction: 0.00-3.00
  • Laboratory - 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.
  • Extramuscular Assessment - Myositis Disease Activity Assessment Tool [ Time Frame: Six months ]
    This partially validated tool measures the degree of disease activity of extra-muscular organ systems and muscle. This is a combined tool that includes the MYOSITIS DISEASE ACTIVITY ASSESSMENT VISUAL ANALOGUE SCALES (MYOACT), which is a series of physician's assessments of disease activity, and the MYOSITIS INTENTION TO TREAT ACTIVITY INDEX (MITAX)
Complete list of historical versions of study NCT03092180 on ClinicalTrials.gov Archive Site
Side effects to treatment (glucocorticoid, immunosuppressants and/or human intravenous immunoglobulin) [ Time Frame: Six months ]
Same as current
Not Provided
Not Provided
 
Optimizing Treatment on Idiopathic Inflammatory Myopathies
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.

To compare two groups of patients as described in Brief Summary.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Serum and muscle biopsies

NOTE: This is a observational study. Subjects in the study will receive a routine care that has been established in our Instituition (diagnostic, therapeutic, biospecimen analysis and retention).

Non-Probability Sample
Idiopathic inflammatory myopathies
Idiopathic Inflammatory Myopathies
Drug: Intravenous Infusion
Intravenous infusion of follow medicine at disease onset: methyprednisolone and/or human intravenous immunoglobulin
Other Name: Medicine
  • Idiopathic inflammatory myopathies 1
    Intravenous infusion with methyprednisolone / human intravenous immunoglobulin at disease onset
    Intervention: Drug: Intravenous Infusion
  • Idiopathic inflammatory myopathies 2
    Intravenous infusion with methyprednisolone at disease onset
    Intervention: Drug: Intravenous Infusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
January 2026
January 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Idiopathic inflammatory myopathies

Exclusion Criteria:

  • Inclusion body myositis, muscular dystrophies, neoplasia-associated myopathies, overlapped myopathies, others myopathies
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Samuel K Shinjo, PhD 55-11-3061-7176 samuel.shinjo@gmail.com
Brazil
 
 
NCT03092180
MYO-HCFMUSP-01
Yes
Not Provided
Plan to Share IPD: No
Samuel Katsuyuki Shinjo, PhD, University of Sao Paulo
University of Sao Paulo
Not Provided
Principal Investigator: Samuel K Shinjo, PhD Universidade de Sao Paulo - Rheumatology Division
University of Sao Paulo
March 2017