Dermatomyositis and Polymyositis Registry (ADAPT)
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Purpose
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 | Intervention |
|---|---|
|
Dermatomyositis Polymyositis |
Drug: Acthar |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only |
| Official Title: | Acthar Dermatomyositis and Polymyositis Treatment |
- Determining if Acthar treatment improves disease progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]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
- Subgroups may predict response to Acthar therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]To determine if there are different subgroups that can be defined myopathologically that may predict response to Acthar therapy.
Biospecimen Retention: None Retained
This is a retrospective and prospective study
| Estimated Enrollment: | 100 |
| Study Start Date: | April 2013 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
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Drug: Acthar
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
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| Contact: Todd D Levine, MD | 602 258 2432 | levine865@aol.com |
| Contact: Nicole C Hank, MHSM | 602 258 2432 | nhank@pnal.net |
| United States, Arizona | |
| PNA Center for Neurological Research | Recruiting |
| Phoenix, Arizona, United States, 85018 | |
| Contact: Nicole C Hank, MHSM 602-258-2432 nhank@pnal.net | |
| Principal Investigator: Todd D Levine, MD | |
| United States, California | |
| California Pacific Medical Center | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: John Katz, MD 415-600-3180 | |
| Principal Investigator: Jon Katz, MD | |
| United States, Maryland | |
| Johns Hopkins University | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Lisa Christopher-Stine, MD 410-955-5000 | |
| Principal Investigator: Lisa Christopher-Stine, MD | |
| United States, Pennsylvania | |
| University of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States | |
| Contact: Chet Oddis, MD 412-624-4141 | |
| Principal Investigator: Chet Oddis, MD | |
| Principal Investigator: | Todd D Levine, MD | Phoenix Neurological Associates, LTD |
| Principal Investigator: | John Katz, MD | University of California Pacific |
| Principal Investigator: | Lisa Christopher-Stine, MD | John Hopkins Hospital |
| Principal Investigator: | Chet Oddis, MD | University of Pittsburgh |
| Principal Investigator: | Lara Katzin, MD | University of South Florida |
More Information
No publications provided
| Responsible Party: | Phoenix Neurological Associates, LTD |
| ClinicalTrials.gov Identifier: | NCT01637064 History of Changes |
| Other Study ID Numbers: | ADAPT |
| Study First Received: | July 6, 2012 |
| Last Updated: | April 2, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Phoenix Neurological Associates, LTD:
|
Myositis Acthar treatment |
Additional relevant MeSH terms:
|
Dermatomyositis Polymyositis Myositis Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases Nervous System Diseases |
Connective Tissue Diseases Skin Diseases Adrenocorticotropic Hormone Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013