Samuel Katsuyuki Shinjo
São Paulo, 01246903, Brazil
Location status: Recruiting
NCT Number: NCT03092180
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
São Paulo, 01246903, Brazil
Location status: Recruiting
To compare two groups of patients as described in Brief Summary.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous infusion of follow medicine at disease onset: methyprednisolone and/or human intravenous immunoglobulin
Other names: Medicine
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.
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.
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.
Time frame: Six months
Define the health assessement questionnaire. Pontuaction: 0.00-3.00
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.
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)
Time frame: Six months
Effect of drugs in disease outcomes
Contact information is provided by the study sponsor or research team.
University of Sao Paulo
Other
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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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