Dermatomyositis and Polymyositis Registry

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Acthar Dermatomyositis and Polymyositis Treatment

Conditions
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Dermatomyositis, Polymyositis

Intervention / Treatment
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* Drug: Acthar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-85 Male or Female Clinical or pathologic diagnosis of polymyositis or dermatomyositis Capable of providing informed consent and complying with treatment regimen Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Acthar|Physicians will prescribe Acthar at their own discretion; however the recommended dose is 80 units subcutaneously twice a week.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determining if Acthar treatment improves disease progression | 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 | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subgroups may predict response to Acthar therapy | To determine if there are different subgroups that can be defined myopathologically that may predict response to Acthar therapy. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myositis, Acthar treatment