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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 : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Samuel Katsuyuki Shinjo, PhD, University of Sao Paulo

Tracking Information
First Submitted Date March 9, 2017
First Posted Date March 27, 2017
Last Update Posted Date April 22, 2019
Study Start Date January 2005
Actual Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 24, 2017)
  • 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)
Original Primary Outcome Measures
 (submitted: March 21, 2017)
  • 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)
Change History Complete list of historical versions of study NCT03092180 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 21, 2017)
Side effects to treatment (glucocorticoid, immunosuppressants and/or human intravenous immunoglobulin) [ Time Frame: Six months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Optimizing Treatment on Idiopathic Inflammatory Myopathies
Official Title Optimizing Treatment on Idiopathic Inflammatory Myopathies
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen 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).

Sampling Method Non-Probability Sample
Study Population Idiopathic inflammatory myopathies
Condition Idiopathic Inflammatory Myopathies
Intervention Drug: Intravenous Infusion
Intravenous infusion of follow medicine at disease onset: methyprednisolone and/or human intravenous immunoglobulin
Other Name: Medicine
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 21, 2017)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2026
Actual Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Idiopathic inflammatory myopathies

Exclusion Criteria:

  • Inclusion body myositis, muscular dystrophies, neoplasia-associated myopathies, overlapped myopathies, others myopathies
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Samuel K Shinjo, PhD 55-11-3061-7176 samuel.shinjo@gmail.com
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT03092180
Other Study ID Numbers MYO-HCFMUSP-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Samuel Katsuyuki Shinjo, PhD, University of Sao Paulo
Study Sponsor University of Sao Paulo
Collaborators Not Provided
Investigators
Principal Investigator: Samuel K Shinjo, PhD Universidade de Sao Paulo - Rheumatology Division
PRS Account University of Sao Paulo
Verification Date April 2019