Dermatomyositis, Polymyositis
Conditions
Keywords
Myositis, Acthar treatment
Brief summary
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
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.
Interventions
DRUGActhar
Physicians will prescribe Acthar at their own discretion; however the recommended dose is 80 units subcutaneously twice a week.
Sponsors
Phoenix Neurological Associates, LTD
Study design
Observational model
CASE_ONLY
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-85 2. Male or Female 3. Clinical or pathologic diagnosis of polymyositis or dermatomyositis 4. Capable of providing informed consent and complying with treatment regimen
Exclusion criteria
1. History of scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex 2. Recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, or sensitivity to proteins of porcine origin 3. Any other co-morbid condition which would make completion of the trial unlikely 4. If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to use appropriate birth control
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determining if Acthar treatment improves disease progression | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subgroups may predict response to Acthar therapy | 2 years | To determine if there are different subgroups that can be defined myopathologically that may predict response to Acthar therapy. |
Countries
United States
Outcome results
None listed