Clinical Trial: Optimizing Treatment on Idiopathic Inflammatory Myopathies

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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 Summary: To compare two groups of patients as described in Brief Summary.
Sponsor: University of Sao Paulo

Current Primary Outcome:

• 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 ]
• 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.
• Same as current
  
  Information By: University of Sao Paulo
  

  Dates:
  Date Received: March 9, 2017
  Date Started: January 2005
  Date Completion: January 2026
  Last Updated: March 24, 2017
  Last Verified: March 2017