Dermatomyositis and Polymyositis Registry

Dermatomyositis Clinical Trial

— ADAPT  

Official title:

Acthar Dermatomyositis and Polymyositis Treatment

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01637064
• Other study ID #: ADAPT
• 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. 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

• Dermatomyositis
• Polymyositis

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