Optimizing Treatment on Idiopathic Inflammatory Myopathies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Physician Global Activity
研究概览
简要总结
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.
详细描述
To compare two groups of patients as described in Brief Summary.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic inflammatory myopathies
排除标准
- •Inclusion body myositis, muscular dystrophies, neoplasia-associated myopathies, overlapped myopathies, others myopathies
研究组 & 干预措施
Idiopathic inflammatory myopathies 1
Intravenous infusion with methyprednisolone / human intravenous immunoglobulin at disease onset
干预措施: Intravenous Infusion (Drug)
Idiopathic inflammatory myopathies 2
Intravenous infusion with methyprednisolone at disease onset
干预措施: Intravenous Infusion (Drug)
结局指标
主要结局
Physician Global Activity
时间窗: 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.
Patient/Parent Global Activity -
时间窗: 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.
Myositis Disease Activity Assessment Tool
时间窗: 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)
Manual Muscle Testing
时间窗: 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.
Health Assessment Questionnaire
时间窗: Six months
Define the health assessement questionnaire. Pontuaction: 0.00-3.00
Muscle Enzymes
时间窗: 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.
次要结局
- Side effects to treatment (glucocorticoid, immunosuppressants and/or human intravenous immunoglobulin)(Six months)
研究者
Samuel Katsuyuki Shinjo, PhD
Principal Investigator
University of Sao Paulo