Acthar Dermatomyositis and Polymyositis Treatment
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Determining if Acthar treatment improves disease progression
研究概览
简要总结
By creating a registry, physicians will have the opportunity to understand the clinical outcomes of Myositis patients treated with Acthar. Despite the availability of clinical exams, muscle biopsies, and other testing, it is surmised that there may be a more important classification of myositis that physicians are not diagnosing which could possibly lead to improper treatment due to inaccurate diagnosis. There may be several types of immune and inflammatory myositis (IIM) that do not fit well into the typical sub classifications of myositis.
详细描述
Retrospective and prospective data will be collected from physicians who have prescribed Acthar to myositis patients to determine what specific characteristics each patient has based on biopsy analysis, laboratory results, and clinical exams. Through biopsy analysis, subcategories of IIM will be determined and could illustrate which of these IIMs may be more responsive to Acthar therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female
- •Clinical or pathologic diagnosis of polymyositis or dermatomyositis
- •Capable of providing informed consent and complying with treatment regimen
排除标准
- •History of scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex
- •Recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, or sensitivity to proteins of porcine origin
- •Any other co-morbid condition which would make completion of the trial unlikely
- •If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to use appropriate birth control
结局指标
主要结局
Determining if Acthar treatment improves disease progression
时间窗: 2 years
To create and maintain a registry linking clinical information, dosing and clinical response in patients with refractory myositis and to determine if Acthar treatment improves disease progression
次要结局
- Subgroups may predict response to Acthar therapy(2 years)