Optimizing Treatment on Idiopathic Inflammatory Myopathies

Idiopathic Inflammatory Myopathies Clinical Trial

Official title:

Optimizing Treatment on Idiopathic Inflammatory Myopathies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03092180
• Other study ID #: MYO-HCFMUSP-01
• Status: Recruiting
• Start date: January 2005
• Est. completion date: May 7, 2024

Study information

• Verified date: May 2024
• Source: University of Sao Paulo
• Contact: Samuel K Shinjo, PhD
• Phone: 55-11-3061-7176
• Email: samuel.shinjo[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 7, 2024
• Est. primary completion date: May 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Idiopathic inflammatory myopathies

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Idiopathic Inflammatory Myopathies
• Muscular Diseases
• Myositis

Intervention

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

Locations

Country	Name	City	State
Brazil	Samuel Katsuyuki Shinjo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Health Assessment Questionnaire	Define the health assessement questionnaire. Pontuaction: 0.00-3.00	Six months
Primary	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
Primary	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	Side effects to treatment (glucocorticoid, immunosuppressants and/or human intravenous immunoglobulin)	Effect of drugs in disease outcomes	Six months