Dermatomyositis and Polymyositis Registry

NCT01637064 | Unknown DMC

• 1 other identifier: ADAPT
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 5

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.

Conditions

Dermatomyositis; Polymyositis

Keywords

Myositis; Acthar treatment

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Subgroups may predict response to Acthar therapy

  2 years

Interventions

Acthar DRUG

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

Also known as: ACTH

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Phoenix Neurological Associates, LTD: lead

Study Sites (5)

PNA Center for Neurological Research

Phoenix, Arizona, 85018, United States

Location

Ara Dikranian MD

San Diego, California, 92108, United States

Location

Neurology INC

Columbia, Missouri, 65201, United States

Location

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

University of Vermont

Burlington, Vermont, 05401, United States

Location

Biospecimen

Retention: NONE RETAINED

This is a retrospective and prospective study

MeSH Terms

Conditions

Dermatomyositis; Polymyositis; Myositis

Interventions

Adrenocorticotropic Hormone

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Todd D Levine, MD

  Phoenix Neurological Associates, LTD

  PRINCIPAL INVESTIGATOR

• Petros Efthimiou, MD

  New York Presbyterian Brooklyn 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2012
• First Posted: July 10, 2012
• Study Start: April 1, 2013
• Primary Completion: December 1, 2015
• Last Updated: November 6, 2015

Record last verified: 2015-11

Locations

US (5)