Predictor of Clinical Response to Acthar in Myositis
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|ClinicalTrials.gov Identifier: NCT03414086|
Recruitment Status : Enrolling by invitation
First Posted : January 29, 2018
Last Update Posted : June 25, 2018
|Condition or disease||Intervention/treatment|
|Myositis Dermatomyositis Polymyositis||Other: Healthy Control Other: Myositis in Remission|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Predictor of Clinical Response to Acthar in Myositis: Phase II of Acthar Clinical Trial|
|Actual Study Start Date :||November 6, 2017|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||June 30, 2019|
Myositis in Remission
Subjects who are in remission with their myositis diagnosis.
Other: Myositis in Remission
Ten patients (four who have polymyositis, six dermatomyositis) from our database who are followed in the Myositis Center. We will collect serum, PBMC's, and RNA samples will be obtained at baseline and at six months. Remission is defined as a global myositis disease activity score less than or equal to 1 on the MDAAT assessments with no new immunosuppressive drug or glucocorticoid use and no increase in dose of either in the preceding year.
Subjects who do not have a myositis diagnosis.
Other: Healthy Control
Ten healthy adult patients evaluating serum, PBMC's, and RNA.
- IMACS Core Set Measures Improvement [ Time Frame: 6 Months ]The International Myositis Assessment & Clinical Studies (IMACS) definition of improvement: Three of any of the six core set measures improved by greater than or equal to twenty percent, with no more than two core set measuring by greater than or equal to twenty five percent.
- Myositis Response Criteria [ Time Frame: 6 Months ]This criteria yields a continuous improvement score which can be more readily extrapolated to individual response in subjects allowing correlation with baseline and longitudinal immunologic markers in these subjects.
Biospecimen Retention: Samples Without DNA
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): NCT03414086
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15261|
|Principal Investigator:||Rohit Aggarwal, MD||University of Pittsburgh|