NCT03414086

Predictor of Clinical Response to Acthar in Myositis

Predictor of Clinical Response to Acthar in Myositis: Phase II of Acthar Clinical Trial

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Comparing the clinical effects of Acthar Gel before and after treatment and compare it to patients with inactive disease.

Detailed description

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".

Conditions

• Myositis
• Dermatomyositis
• Polymyositis

Interventions

Type	Name	Description
OTHER	Healthy Control	Ten healthy adult patients evaluating serum, PBMC's, and RNA.
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.

Timeline

• Start date: 2017-11-06
• Primary completion: 2022-07-30
• Completion: 2022-07-30
• First posted: 2018-01-29
• Last updated: 2022-08-09

Locations

1 site across 1 country: United States