Dermatomyositis and Polymyositis Registry (ADAPT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Phoenix Neurological Associates, LTD
Sponsor:
Information provided by (Responsible Party):
Phoenix Neurological Associates, LTD
ClinicalTrials.gov Identifier:
NCT01637064
First received: July 6, 2012
Last updated: April 2, 2013
Last verified: April 2013
  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:


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

Primary Outcome Measures:
  • Determining if Acthar treatment improves disease progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: October 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Acthar
    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
Genders Eligible for Study:   Both
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:

  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
  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

Contacts
Contact: Todd D Levine, MD 602 258 2432 levine865@aol.com
Contact: Nicole C Hank, MHSM 602 258 2432 nhank@pnal.net

Locations
United States, Arizona
PNA Center for Neurological Research Recruiting
Phoenix, Arizona, United States, 85018
Contact: Nicole C Hank, MHSM    602-258-2432    nhank@pnal.net   
Principal Investigator: Todd D Levine, MD         
United States, California
California Pacific Medical Center Recruiting
San Francisco, California, United States, 94115
Contact: John Katz, MD    415-600-3180      
Principal Investigator: Jon Katz, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Lisa Christopher-Stine, MD    410-955-5000      
Principal Investigator: Lisa Christopher-Stine, MD         
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States
Contact: Chet Oddis, MD    412-624-4141      
Principal Investigator: Chet Oddis, MD         
Sponsors and Collaborators
Phoenix Neurological Associates, LTD
Investigators
Principal Investigator: Todd D Levine, MD Phoenix Neurological Associates, LTD
Principal Investigator: John Katz, MD University of California Pacific
Principal Investigator: Lisa Christopher-Stine, MD John Hopkins Hospital
Principal Investigator: Chet Oddis, MD University of Pittsburgh
Principal Investigator: Lara Katzin, MD University of South Florida
  More Information

No publications provided

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: April 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Phoenix Neurological Associates, LTD:
Myositis
Acthar treatment

Additional relevant MeSH terms:
Polymyositis
Dermatomyositis
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014