Dermatomyositis and Polymyositis Registry (ADAPT)
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ClinicalTrials.gov 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
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Condition or disease | Intervention/treatment |
---|---|
Dermatomyositis Polymyositis | Drug: Acthar |
Study Type : | Observational |
Estimated Enrollment : | 100 participants |
Observational Model: | Case-Only |
Official Title: | Acthar Dermatomyositis and Polymyositis Treatment |
Study Start Date : | April 2013 |
Estimated Primary Completion Date : | December 2015 |

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Drug: Acthar
- 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
- 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.
Biospecimen Retention: None Retained

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01637064
United States, Arizona | |
PNA Center for Neurological Research | |
Phoenix, Arizona, United States, 85018 | |
United States, California | |
Ara Dikranian MD | |
San Diego, California, United States, 92108 | |
United States, Missouri | |
Neurology INC | |
Columbia, Missouri, United States, 65201 | |
United States, New York | |
New York Methodist Hospital | |
Brooklyn, New York, United States, 11215 | |
United States, Vermont | |
University of Vermont | |
Burlington, Vermont, United States, 05401 |
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 |
Responsible Party: | Phoenix Neurological Associates, LTD |
ClinicalTrials.gov Identifier: | NCT01637064 History of Changes |
Other Study ID Numbers: |
ADAPT |
First Posted: | July 10, 2012 Key Record Dates |
Last Update Posted: | November 6, 2015 |
Last Verified: | November 2015 |
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 |