University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
NCT Number: NCT03414086
Comparing the clinical effects of Acthar Gel before and after treatment and compare it to patients with inactive disease.
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Notify Me18 year and older
All sexes
Observational
Pittsburgh, Pennsylvania, 15261, United States
To compare the clinical impact of Acthar Gel at the cellular and molecular level before and after treatment and compare it to patients with inactive disease. The cohort of active myositis subjects are not actually enrolled in this study, but rather the data for those with active myositis will be obtained from a previously completed trial entitled "Efficacy and safety of Adenocorticotropic Hormone Gel in Refractory dermatomyositis and polymyositis".
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ten healthy adult patients evaluating serum, PBMC's, and RNA.
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.
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.
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.
University of Pittsburgh
Other
Predictor of Clinical Response to Acthar in Myositis: Phase II of Acthar Clinical Trial
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