Optimizing Treatment on Idiopathic Inflammatory Myopathies

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.

Study Overview

• Status: Recruiting
• Conditions: Idiopathic Inflammatory Myopathies
• Intervention / Treatment: Drug: Intravenous Infusion

Detailed Description

To compare two groups of patients as described in Brief Summary.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Samuel K Shinjo, PhD; Phone Number: 55-11-3061-7176; Email: samuel.shinjo@gmail.com

Study Locations

• Brazil
  • Sao Paulo, Brazil, 01246903
    • Recruiting
    • Samuel Katsuyuki Shinjo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Idiopathic inflammatory myopathies

Description

Inclusion Criteria:

• Idiopathic inflammatory myopathies

Exclusion Criteria:

• Inclusion body myositis, muscular dystrophies, neoplasia-associated myopathies, overlapped myopathies, others myopathies

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Idiopathic inflammatory myopathies 1; Intravenous infusion with methyprednisolone / human intravenous immunoglobulin at disease onset	Drug: Intravenous Infusion; Intravenous infusion of follow medicine at disease onset: methyprednisolone and/or human intravenous immunoglobulin; Other Names: Medicine
Idiopathic inflammatory myopathies 2; Intravenous infusion with methyprednisolone at disease onset	Drug: Intravenous Infusion; Intravenous infusion of follow medicine at disease onset: methyprednisolone and/or human intravenous immunoglobulin; Other Names: Medicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects to treatment (glucocorticoid, immunosuppressants and/or human intravenous immunoglobulin)	Effect of drugs in disease outcomes	Six months

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Samuel K Shinjo, PhD, Universidade de Sao Paulo - Rheumatology Division

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): May 6, 2024
• Study Completion (Estimated): December 4, 2024

Study Registration Dates

• First Submitted: March 9, 2017
• First Submitted That Met QC Criteria: March 21, 2017
• First Posted (Actual): March 27, 2017

Study Record Updates

• Last Update Posted (Actual): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Myositis; Dermatomyositis; Immunomodulation; Polymyositis; Immunosuppressive agents; Necrotizing myopathies; Antisynthetase syndrome
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Neuromuscular Diseases; Muscular Diseases; Myositis
• Other Study ID Numbers: MYO-HCFMUSP-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO