Dermatomyositis and Polymyositis Registry - Full Text View

Purpose

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.

Condition	Intervention
Dermatomyositis Polymyositis	Drug: Acthar


Study Type:	Observational
Study Design:	Observational Model: Case-Only
Official Title:	Acthar Dermatomyositis and Polymyositis Treatment

Resource links provided by NLM:

Drug Information available for: Corticotropin

Genetic and Rare Diseases Information Center resources: Dermatomyositis Idiopathic Inflammatory Myopathy Polymyositis

U.S. FDA Resources

Further study details as provided by Phoenix Neurological Associates, LTD:

Primary Outcome Measures:

Determining if Acthar treatment improves disease progression [ Time Frame: 2 years ]
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

Secondary Outcome Measures:

Subgroups may predict response to Acthar therapy [ Time Frame: 2 years ]
To determine if there are different subgroups that can be defined myopathologically that may predict response to Acthar therapy.

Biospecimen Retention: None Retained

This is a retrospective and prospective study


Estimated Enrollment:	100
Study Start Date:	April 2013
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Intervention Details:

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

Other Name: ACTH

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


Ages Eligible for Study:	18 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
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

Criteria

Inclusion Criteria:

Age 18-85
Male or Female
Clinical or pathologic diagnosis of polymyositis or dermatomyositis
Capable of providing informed consent and complying with treatment regimen

Exclusion Criteria:

History of scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex
Recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, or sensitivity to proteins of porcine origin
Any other co-morbid condition which would make completion of the trial unlikely
If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to use appropriate birth control

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01637064

Locations


United States, Arizona
PNA Center for Neurological Research
Phoenix, Arizona, United States, 85018
United States, California
Ara Dikranian MD
San Diego, California, United States, 92108
United States, Missouri
Neurology INC
Columbia, Missouri, United States, 65201
United States, New York
New York Methodist Hospital
Brooklyn, New York, United States, 11215
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05401

Sponsors and Collaborators

Phoenix Neurological Associates, LTD

Investigators


Principal Investigator:	Todd D Levine, MD	Phoenix Neurological Associates, LTD
Principal Investigator:	Petros Efthimiou, MD	New York Methodist Hospital
Principal Investigator:	Ara Dikranian, MD	Ara Dikranian MD
Principal Investigator:	Justine Malone, MD	Neurology INC
Principal Investigator:	Rup Tandan, MD	University of Vermont

More Information


Responsible Party:	Phoenix Neurological Associates, LTD
ClinicalTrials.gov Identifier:	NCT01637064 History of Changes
Other Study ID Numbers:	ADAPT
Study First Received:	July 6, 2012
Last Updated:	November 5, 2015

Keywords provided by Phoenix Neurological Associates, LTD:


Myositis Acthar treatment

Additional relevant MeSH terms:


Dermatomyositis Polymyositis Myositis Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases Nervous System Diseases	Connective Tissue Diseases Skin Diseases Adrenocorticotropic Hormone Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 23, 2017

Dermatomyositis and Polymyositis Registry (ADAPT)