Dermatomyositis and Polymyositis Registry (ADAPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01637064
Recruitment Status : Unknown
Verified November 2015 by Phoenix Neurological Associates, LTD.
Recruitment status was:  Enrolling by invitation
First Posted : July 10, 2012
Last Update Posted : November 6, 2015
Information provided by (Responsible Party):
Phoenix Neurological Associates, LTD

July 6, 2012
July 10, 2012
November 6, 2015
April 2013
December 2015   (Final data collection date for primary outcome measure)
Determining if Acthar treatment improves disease progression [ Time Frame: 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
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Complete list of historical versions of study NCT01637064 on Archive Site
Subgroups may predict response to Acthar therapy [ Time Frame: 2 years ]
To determine if there are different subgroups that can be defined myopathologically that may predict response to Acthar therapy.
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Dermatomyositis and Polymyositis Registry
Acthar Dermatomyositis and Polymyositis Treatment
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.
Observational Model: Case-Only
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Retention:   None Retained
This is a retrospective and prospective study
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
  • Dermatomyositis
  • Polymyositis
Drug: Acthar
Physicians will prescribe Acthar at their own discretion; however the recommended dose is 80 units subcutaneously twice a week.
Other Name: ACTH
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
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December 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Phoenix Neurological Associates, LTD
Phoenix Neurological Associates, LTD
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Principal Investigator: Todd D Levine, MD Phoenix Neurological Associates, LTD
Principal Investigator: Petros Efthimiou, MD New York 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
Phoenix Neurological Associates, LTD
November 2015