NCT03092180|RecruitingDMC
Loading search results
Sponsor study identifier
observational
60
1 country
1
Study Start
January 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 6, 2024
Actual (reported)Study Completion
December 4, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 4, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2005
Date type not reportedThis date has not been verified as actual or estimated.
March 9, 2017
Actual (reported)March 27, 2017
Actual (reported)May 6, 2024
Actual (reported)December 4, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Physician Global Activity
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.
Six months
Patient/Parent Global Activity -
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.
Six months
Manual Muscle Testing
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.
Six months
Side effects to treatment (glucocorticoid, immunosuppressants and/or human intravenous immunoglobulin)
Six months
Intravenous infusion with methyprednisolone / human intravenous immunoglobulin at disease onset
Intravenous infusion with methyprednisolone at disease onset
Intravenous infusion of follow medicine at disease onset: methyprednisolone and/or human intravenous immunoglobulin
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Idiopathic inflammatory myopathies
Contact the study team to confirm eligibility.
Samuel Katsuyuki Shinjo
São Paulo, 01246903, Brazil
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).
Samuel K Shinjo, PhD
Universidade de Sao Paulo - Rheumatology Division
First Submitted
March 9, 2017
First Posted
March 27, 2017
Study Start
January 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 6, 2024
Intravenous immunoglobulin and prednisone vs. prednisone in newly diagnosed myositis: a double blind randomized clinical trial
Health Assessment Questionnaire
Define the health assessement questionnaire. Pontuaction: 0.00-3.00
Six months
Muscle Enzymes
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.
Six months
Myositis Disease Activity Assessment Tool
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)
Six months
Study Completion
December 4, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 5, 2024
Record last verified: 2024-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: