Dermatomyositis and Polymyositis Registry (ADAPT)

Phoenix Neurological Associates, LTD

Status: Unknown

Conditions: Dermatomyositis; Polymyositis

Treatments: Drug: Acthar

Study type: Observational

Funder types: Other

Identifiers

NCT01637064

ADAPT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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