ADAPT: Dermatomyositis and Polymyositis Registry
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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.
Study Design
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | PNA Center for Neurological Research | Phoenix | Arizona | United States | 85018 |
| 2 | Ara Dikranian MD | San Diego | California | United States | 92108 |
| 3 | Neurology INC | Columbia | Missouri | United States | 65201 |
| 4 | New York Methodist Hospital | Brooklyn | New York | United States | 11215 |
| 5 | University of Vermont | Burlington | Vermont | United States | 05401 |
Sponsors and Collaborators
- Phoenix Neurological Associates, LTD
Investigators
- Principal Investigator: 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ADAPT