Clinical Trial: Dermatomyositis and Polymyositis Registry

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational

Official Title: Acthar Dermatomyositis and Polymyositis Treatment

Brief 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 Summary: 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.
Sponsor: Phoenix Neurological Associates, LTD

Current Primary Outcome: Determining if Acthar treatment improves disease progression [ Time Frame: 2 years ]

To create and maintain a registry linking clinical information, dosing and clinical response in patients with refractory myositis and to determine if Acthar treatment improves disease progression


Original Primary Outcome:

Current Secondary Outcome: Subgroups may predict response to Acthar therapy [ Time Frame: 2 years ]

To determine if there are different subgroups that can be defined myopathologically that may predict response to Acthar therapy.


Original Secondary Outcome:

Information By: Phoenix Neurological Associates, LTD

Dates:
Date Received: July 6, 2012
Date Started: April 2013
Date Completion:
Last Updated: November 5, 2015
Last Verified: November 2015