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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01637064
Other study ID # ADAPT
Secondary ID
Status Enrolling by invitation
Phase N/A
First received July 6, 2012
Last updated November 5, 2015
Start date April 2013

Study information

Verified date November 2015
Source Phoenix Neurological Associates, LTD
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 100
Est. completion date
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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

Observational Model: Case-Only


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States New York Methodist Hospital Brooklyn New York
United States University of Vermont Burlington Vermont
United States Neurology INC Columbia Missouri
United States PNA Center for Neurological Research Phoenix Arizona
United States Ara Dikranian MD San Diego California

Sponsors (1)

Lead Sponsor Collaborator
Phoenix Neurological Associates, LTD

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determining if Acthar treatment improves disease progression 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 2 years No
Secondary Subgroups may predict response to Acthar therapy To determine if there are different subgroups that can be defined myopathologically that may predict response to Acthar therapy. 2 years No
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