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

Open for Recruitment

Study Background

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

Open for Recruitment

This study will evaluate subjects with adult- and childhood-onset myositis to learn more about their causes and the immune system changes and medical problems associated with them. Myositis is an inflammatory muscle disease that can damage muscles and other organs, resulting in significant disability.

This study also intends to investigate the genetic and environmental risk factors involved in the development of myositis, an autoimmune muscle disease that causes chronic muscle weakness. Adults and children diagnosed with myositis may enroll by completing questionnaires and donating blood and urine samples.

For more information on this study, please visit the Clinical Trials Study page.

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Eligibility

Inclusion Criteria:

All patients admitted to the study must satisfy the following criteria:

  1. Meet probable or definite criteria for Idiopathic Inflammatory Myopathies (IIM) 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. A minimum assessment of a comprehensive history and physical examination, review of all relevant outside medical records, and drawing a blood specimen from the patient would be required.
  3. Selected patients with undefined illnesses who may have weakness, myalgias, or an elevated CK may be evaluated to establish a diagnosis and, if they are found to have IIM, would be offered the opportunity to enter the study. Such patients would undergo history and physical examination, blood tests when clinically indicated (incl. 20 cc for research purposes), and other procedures as clinically indicated, including an MRI examination to establish an optimal site for muscle biopsy.
  4. For patients with at least one first-degree relative affected with IIIM, we will enroll all available first degree relatives (affected and unaffected) to participate in the genetics portion of the protocol. A minimum assessment of a comprehensive history and physical examination, review of all relevant outside medical records, and drawing a blood specimen from the patient would be required, with other testing to exclude myositis performed as clinically indicated.

Exclusion Criteria: 

  1. Severe medical disease requiring intensive care or any other conditions in which the drawing of the amount of blood required or undergoing procedures needed for the study is not deemed medically appropriate by the treating physician or the principal investigator.

What will you do?

Adults and children are eligible to participate if they have been diagnosed with any disease indicated above. Healthy volunteers will also be asked to participate.  This is a blood, urine, and data collection study. A single visit and evaluation is all that is required. All patients will undergo a complete history (including completing questionnaires) and physical examination, review of medical records, and blood and urine tests. Patients may then choose to participate in an additional 1- to 5-day evaluation, which will include additional diagnostic or research procedures.

Study Location

Subjects may be enrolled at the NIH Clinical Center, 9000 Rockville Pike, Bethesda, MD, 20892, or in your local doctor’s office.

Protocol Number: 94-E-0165

Enrollment and Contact Information

Referral/Patient Recruitment 
Warren Grant Magnuson Clinical Center
National Institutes of Health
Bethesda, Maryland 20892-2655
Tel 800-411-1222
Fax (301) 451-5588
prpl@mail.cc.nih.gov

Principal Investigator

Adult Subjects

Adam I. Schiffenbauer
Adam I. Schiffenbauer, M.D.
Staff Clinician
Environmental Autoimmunity Group, Clinical Research Branch
Tel 301-451-6270
adam.shiffenbauer@nih.gov
10 Center Dr
Clinical Center Surgical Wing
Bethesda, MD 20892-1627
Frederick W. Miller
Frederick W. Miller, M.D., Ph.D.
Deputy Chief, Clinical Research Branch and Principal Investigator
Tel 919-316-4674
Fax 919-451-5585
millerf@mail.nih.gov
P.O. Box 12233
Mail Drop F1-09
Durham, N.C. 27709

Pediatric Subjects

Lisa Rider, M.D.
Lisa Rider, M.D.
Deputy Chief and Staff Clinician, Environmental Autoimmunity Group
Tel 301-451-6272
Fax 301-480-2813
riderl@mail.nih.gov
10 Center Dr
Hatfield Clinical Research Center
Bethesda, MD 20892-1301