A Novel Anti-inflammation Treatment for Idiopathic Inflammatory Myopathies
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to learn if the drug Maraviroc works to treat refractory idiopathic inflammatory myopathy (myositis) in patients who have not responded well to traditional therapies. It will also learn about how the drug affects muscle inflammation and function. The main questions it aims to answer are: Does Maraviroc reduce inflammation in the muscles? Does Maraviroc improve patients' muscle function and overall clinical symptoms? This is an open-label study, meaning researchers will give Maraviroc to all participants (there is no placebo) to see if the drug works to treat refractory myositis. Participants will: Take a 300mg Maraviroc tablet every day for 12 weeks. Undergo exams and tests with their doctors to check their muscle function, symptom improvement, and specific health markers (like enzyme levels).
详细描述
Objective:
This is an open-label clinical trial using Maraviroc for the treatment of refractory idiopathic inflammatory myopathy (myositis).
The hypothesis to be tested:
Findings from our pilot study demonstrate that Maraviroc has an anti-inflammatory effect in both dystrophic and aging muscle. We thus hypothesize that Maraviroc can be used for treating patients with refractory myositis by repressing the inflammation in muscles.
Design and subjects:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 to <80 years of age
- •Myositis disease onset >18 years
- •Fulfillment of 2017 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) IIM classification criteria
- •Active myositis defined as Manual Muscle Testing 8 (MMT8) score <142 with at least two other abnormal International Myositis Assessment & Clinical Studies Group (IMACS) core set measures (Visual Analogue Scale (VAS) of patient global activity ≥2 cm, physician's global disease activity ≥2 cm, at least one muscle enzyme >1.5 times upper limit of normal, Health ssessment Questionnaire(HAQ) ≥0.25), despite 2 additional immunosuppressive treatments on top of glucocorticoids.
排除标准
- •Pregnancy or lactation,
- •Functional class 4
- •Contraindication to Maraviroc.
结局指标
主要结局
未指定
次要结局
- Muscle histological features(From enrollment to the end of treatment at 12 weeks)
- Muscle oedema (inflammation) and fatty infiltration (damage)(From enrollment to the end of treatment at 12 weeks)
研究者
Huating Wang
Professor
Chinese University of Hong Kong