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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acthar | Drug | Physicians will prescribe Acthar at their own discretion; however the recommended dose is 80 units subcutaneously twice a week. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All sites chosen are well-established universities, academic centers or private practices that specialize in neuromuscular diseases. These are physicians who have several myositis patients and who are prescribing or would prescribe Acthar to myositis patients
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| Name | Affiliation | Role |
|---|---|---|
| Todd D Levine, MD | Phoenix Neurological Associates, LTD | Principal Investigator |
| Petros Efthimiou, MD | New York Presbyterian Brooklyn Methodist Hospital | Principal Investigator |
| Ara Dikranian, MD | Ara Dikranian MD | Principal Investigator |
| Justine Malone, MD | Neurology INC | Principal Investigator |
| Rup Tandan, MD | University of Vermont | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PNA Center for Neurological Research | Phoenix | Arizona | 85018 | United States | ||
| Ara Dikranian MD |
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| ID | Term |
|---|---|
| D003882 | Dermatomyositis |
| D017285 | Polymyositis |
| D009220 | Myositis |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000324 | Adrenocorticotropic Hormone |
| ID | Term |
|---|---|
| D053486 | Melanocortins |
| D011333 | Pro-Opiomelanocortin |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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This is a retrospective and prospective study
| San Diego |
| California |
| 92108 |
| United States |
| Neurology INC | Columbia | Missouri | 65201 | United States |
| New York Methodist Hospital | Brooklyn | New York | 11215 | United States |
| University of Vermont | Burlington | Vermont | 05401 | United States |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |