NCT01637064

Dermatomyositis and Polymyositis Registry

Acthar Dermatomyositis and Polymyositis Treatment

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Phoenix Neurological Associates, LTD · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

By creating a registry, physicians will have the opportunity to understand the clinical outcomes of Myositis patients treated with Acthar. Despite the availability of clinical exams, muscle biopsies, and other testing, it is surmised that there may be a more important classification of myositis that physicians are not diagnosing which could possibly lead to improper treatment due to inaccurate diagnosis. There may be several types of immune and inflammatory myositis (IIM) that do not fit well into the typical sub classifications of myositis.

Detailed description

Retrospective and prospective data will be collected from physicians who have prescribed Acthar to myositis patients to determine what specific characteristics each patient has based on biopsy analysis, laboratory results, and clinical exams. Through biopsy analysis, subcategories of IIM will be determined and could illustrate which of these IIMs may be more responsive to Acthar therapy.

Conditions

• Dermatomyositis
• Polymyositis

Interventions

Type	Name	Description
DRUG	Acthar	Physicians will prescribe Acthar at their own discretion; however the recommended dose is 80 units subcutaneously twice a week.

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-12-01
• First posted: 2012-07-10
• Last updated: 2015-11-06

Locations

5 sites across 1 country: United States