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Studies in the Natural History & Pathogenesis of Childhood-Onset and Adult-Onset Idiopathic Inflammatory Myopathies

Myositis Study – 94-E-0165

Study Design
This study will evaluate selected subjects with childhood-onset and adult-onset myositis to learn more about their cause and the immune system changes and medical problems associated with them. A secondary goal is to better define the complications of illness and how to best assess these. Myositis is an inflammatory muscle disease that can damage muscles and other organs, resulting in significant disability. The hope is that such studies will allow for better treatments or even the prevention of these diseases.


To better understand which genes might be causing childhood onset myositis, and what factors (laboratory-based and clinical) predict disease outcomes. Blood and urine will be collected from all subjects, and all subjects or their parents will be asked to complete questionnaires about their medical history. Different tests may also be performed to assess how the illness is affecting different parts of the body.


Selected subjects with myositis and healthy volunteers


Number of subjects


Overview of the Study and Evaluations

  1. The goal of the study is to understand the genetic factors that may result in childhood-onset and adult-onset myositis, to define new outcome measures and better define outcomes for these diseases
  2. Subjects enroll at the NIH Clinical Center in Bethesda, Maryland or in the local doctor's office.
  3. A letter from a referring physician is required.
  4. All subjects will have a baseline evaluation; selected subjects may return for 1 or 2 follow-up visits
  5. Medical records, questionnaires, and blood and urine samples will be collected at enrollment.
  6. Other testing's are performed on a selective basis, and may include muscle strength and physical function testing, skin evaluation, swallowing and speech evaluation, heart and lung studies, magnetic resonance imaging of muscles, aerobic exercise testing, as well as muscle biopsy


Recruitment Detail
Gender: Male & Female
Ages: Children and adults


Population Exclusion(s)


Eligibility Criteria

  1. Selected patients of interest who meet probable or definite criteria for Polymyositis or Dermatomyositis by Bohan and Peter
  2. Ability of patient or parent/guardian to give informed consent to all or part of the study after full information has been provided
  3. Normal healthy volunteers, who do not have an autoimmune or inflammatory disease, and who are matched to enrolled patients, are also eligible to enroll in the study


Treatment Intervention


Additional information is available in the representative protocol consent and assent below:

  1. Patient consent(163KB)
  2. Assent for minor patient(35KB)


More information may also be found at the website below: 


Study Sites
Subjects may be enrolled at the NIH Clinical Center, 9000 Rockville Pike, Bethesda, MD, 20892.


Study Contacts


Adult Subjects

Irene Z. Whitt, M.D.
NIH, Warren Grant Magnuson Clinical Center
10 Center Drive, Bldg. 10, Room 6C432D, MSC 1627
Bethesda, Maryland 20892-1627
Tel (301) 451-6270,1-888-271-3207
Fax (301) 451-5717
Frederick W. Miller, M.D., Ph.D.
Principal Investigator
Hatfield Clinical Research Center, NIH
10 Center Drive, Bldg. 10, Room 4-2352, MSC 1301
Bethesda, Maryland 20892-1301
Tel (301) 451-6273, 1-888-271-3207
Fax (301) 451-5585

Pediatric Subjects

Lisa G. Rider, M.D.
Deputy Chief
Environmental Autoimmunity Group
Hatfield Clinical Research Center, NIH
10 Center Drive, Bldg. 10, Room 4-2352, MSC 1301
Bethesda, Maryland 20892-1301
Tel (301) 451-6272,1-888-271-3207
Fax (301) 451-5588
Referral/Patient Recruitment
Warren Grant Magnuson Clinical Center
National Institutes of Health
Bethesda, Maryland 20892-2655
Tel 1-800-411-1222, TTY 1-866-411-
Fax (301) 451-5588

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