Clinical trial NCT01637064: Dermatomyositis and Polymyositis Registry
Official title: Acthar Dermatomyositis and Polymyositis Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dermatomyositis
Polymyositis
Keywords: Myositis
Acthar treatment
Lead sponsor: Phoenix Neurological Associates, LTD
Sponsor class: OTHER
First posted: 2012-07-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All sites chosen are well-established universities, academic centers or private practices that specialize in neuromuscular diseases. These are physicians who have several myositis patients and who are prescribing or would prescribe Acthar to myositis patients

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.

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

Primary outcomes:
measure: Determining if Acthar treatment improves disease progression
timeFrame: 2 years
Secondary outcomes:
measure: Subgroups may predict response to Acthar therapy
timeFrame: 2 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: PNA Center for Neurological Research
state: Arizona
city: San Diego
country: United States
facility: Ara Dikranian MD
state: California
city: Columbia
country: United States
facility: Neurology INC
state: Missouri
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: Phoenix Neurological Associates, LTD
name: Todd D Levine, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York Presbyterian Brooklyn Methodist Hospital
name: Petros Efthimiou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ara Dikranian MD
name: Ara Dikranian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neurology INC
name: Justine Malone, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Vermont
name: Rup Tandan, MD
role: PRINCIPAL_INVESTIGATOR
References: