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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 November 2015 |
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Main ID: |
NCT01637064 |
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Date of registration:
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06/07/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Dermatomyositis and Polymyositis Registry
ADAPT |
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Scientific title:
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Acthar Dermatomyositis and Polymyositis Treatment |
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Date of first enrolment:
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April 2013 |
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Target sample size:
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100 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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https://clinicaltrials.gov/show/NCT01637064 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Petros Efthimiou, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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New York Methodist Hospital |
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Name:
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Todd D Levine, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Phoenix Neurological Associates, LTD |
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Name:
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Rup Tandan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Vermont |
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Name:
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Justine Malone, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Neurology INC |
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Name:
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Ara Dikranian, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ara Dikranian MD |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dermatomyositis
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Polymyositis
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Intervention(s)
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Drug: Acthar
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Primary Outcome(s)
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Determining if Acthar treatment improves disease progression
[Time Frame: 2 years]
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Secondary Outcome(s)
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Subgroups may predict response to Acthar therapy
[Time Frame: 2 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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