Dermatomyositis and Polymyositis Registry

NCT ID: NCT01637064

Last Updated: 2015-11-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-04-30

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.

Conditions

Dermatomyositis; Polymyositis

Study Design

• Observational Model Type: CASE_ONLY

Interventions

Acthar

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

Intervention Type: DRUG

Other Intervention Names

ACTH

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Phoenix Neurological Associates, LTD

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Todd D Levine, MD

Role: PRINCIPAL_INVESTIGATOR

Phoenix Neurological Associates, LTD

Petros Efthimiou, MD

Role: PRINCIPAL_INVESTIGATOR

New York Presbyterian Brooklyn Methodist Hospital

Ara Dikranian, MD

Role: PRINCIPAL_INVESTIGATOR

Ara Dikranian MD

Justine Malone, MD

Role: PRINCIPAL_INVESTIGATOR

Neurology INC

Rup Tandan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Locations

PNA Center for Neurological Research

Phoenix, Arizona, United States

Ara Dikranian MD

San Diego, California, United States

Neurology INC

Columbia, Missouri, United States

New York Methodist Hospital

Brooklyn, New York, United States

University of Vermont

Burlington, Vermont, United States

Countries

United States

Other Identifiers

ADAPT

Identifier Type: -

Identifier Source: org_study_id