Optimizing Treatment on Idiopathic Inflammatory Myopathies

NCT03092180 | Recruiting DMC

• 1 other identifier: MYO-HCFMUSP-01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Inflammatory Myopathies

Keywords

Dermatomyositis; Immunomodulation; Immunosuppressive agents; Myositis; Polymyositis; Necrotizing myopathies; Antisynthetase syndrome

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Side effects to treatment (glucocorticoid, immunosuppressants and/or human intravenous immunoglobulin)

  Six months

Study Arms (2)

Idiopathic inflammatory myopathies 1

Intravenous infusion with methyprednisolone / human intravenous immunoglobulin at disease onset

Drug: Intravenous Infusion

Idiopathic inflammatory myopathies 2

Intravenous infusion with methyprednisolone at disease onset

Drug: Intravenous Infusion

Interventions

Intravenous Infusion DRUG

Intravenous infusion of follow medicine at disease onset: methyprednisolone and/or human intravenous immunoglobulin

Also known as: Medicine

Idiopathic inflammatory myopathies 1; Idiopathic inflammatory myopathies 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Idiopathic inflammatory myopathies

You may qualify if:

• Idiopathic inflammatory myopathies

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Samuel Katsuyuki Shinjo

São Paulo, 01246903, Brazil

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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).

MeSH Terms

Conditions

Myositis; Dermatomyositis; Polymyositis; Antisynthetase syndrome

Interventions

Infusions, Intravenous; Dosage Forms

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Samuel K Shinjo, PhD

  Universidade de Sao Paulo - Rheumatology Division

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel K Shinjo, PhD

CONTACT

55-11-3061-7176; samuel.shinjo@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2017
• First Posted: March 27, 2017
• Study Start: January 1, 2005
• Primary Completion: May 6, 2024
• Study Completion: December 4, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)