Dermatomyositis and Polymyositis Registry

• Conditions: Dermatomyositis; Polymyositis

• Registration Number: NCT01637064
• Lead Sponsor: Phoenix Neurological Associates, LTD

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 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.

Study Timeline

• Study First Submitted: 2012-07-06
• Study First Submitted QC: 2012-07-06
• Study First Posted: 2012-07-10
• Study Start: 2013-04
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-05
• Last Update Posted: 2015-11-06
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Age 18-85
2. Male or Female
3. Clinical or pathologic diagnosis of polymyositis or dermatomyositis
4. Capable of providing informed consent and complying with treatment regimen

Exclusion Criteria

1. History of scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex
2. Recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, or sensitivity to proteins of porcine origin
3. Any other co-morbid condition which would make completion of the trial unlikely
4. If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to use appropriate birth control

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determining if Acthar treatment improves disease progression	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

Secondary Outcome Measures

Name	Time	Method
Subgroups may predict response to Acthar therapy	2 years	To determine if there are different subgroups that can be defined myopathologically that may predict response to Acthar therapy.

Trial Locations

Locations (5)

PNA Center for Neurological Research; 🇺🇸 Phoenix, Arizona, United States

Neurology INC; 🇺🇸 Columbia, Missouri, United States

New York Methodist Hospital; 🇺🇸 Brooklyn, New York, United States

Ara Dikranian MD; 🇺🇸 San Diego, California, United States

University of Vermont; 🇺🇸 Burlington, Vermont, United States