Recruiting NCT03092180
Optimizing Treatment on Idiopathic Inflammatory Myopathies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intravenous Infusion.
- Who it may be relevant to
- Registry conditions: Idiopathic Inflammatory Myopathies. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug Intravenous Infusion
Intravenous infusion of follow medicine at disease onset: methyprednisolone and/or human intravenous immunoglobulin
Primary outcome measures
- Physician Global Activity [Time frame: Six months]
- Patient/Parent Global Activity - [Time frame: Six months]
- Manual Muscle Testing [Time frame: Six months]
- Health Assessment Questionnaire [Time frame: Six months]
- Muscle Enzymes [Time frame: Six months]
- Myositis Disease Activity Assessment Tool [Time frame: Six months]
Secondary outcome measures (1)
- Side effects to treatment (glucocorticoid, immunosuppressants and/or human intravenous immunoglobulin) [Time frame: Six months]
Eligibility criteria
Inclusion criteria
- Idiopathic inflammatory myopathies
Exclusion criteria
- Inclusion body myositis, muscular dystrophies, neoplasia-associated myopathies, overlapped myopathies, others myopathies
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Brazil · 1 center
- Samuel Katsuyuki Shinjo — São Paulo
Identifiers
NCT: NCT03092180 · MYO-HCFMUSP-01