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Environmental Risk Factors for the Anti-Synthetase Syndrome – The MYORISK Study

Open for Recruitment

Study Background

Additional Information

Doctor and Patient reviewing a chart
Study Flyer(849KB)

Anti-Synthetase Syndrome Podcast

Environmental Risk Factors for the Anti-Synthetase Syndrome – The MYORISK Study

Open for Recruitment

This study 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 within the last year may enroll by completing questionnaires and donating blood and urine samples.

Like other complex diseases, autoimmune diseases are the result of numerous causes, including genetic and environmental factors. Some researchers believe that people who are susceptible to autoimmune disorders develop them when the body reacts to environmental or other factors by creating white blood cells that attack the body's own tissues, which then progresses to autoimmune diseases. These immune-triggered disorders can overlap with one another to some extent, but most autoimmune diseases have certain distinct triggers.

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

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Please visit NIEHS Syndication to get started.

Eligibility

Inclusion Criteria:

  1. Adults or children with myositis are eligible to participate if they have been diagnosed with possible, probable, or definite myositis within the last 24 months.
  2. Healthy controls will be sex- and age-matched (within 5 years for children and 10 years for adults) to the myositis patients with the Anti-Synthetase syndrome.
  3. Healthy controls will ideally be friends or cousins of the Anti-Synthetase syndrome patients who are also living in the same geographic area as the antisynthetase syndrome patients.

Exclusion Criteria:

  1. Exclusion criteria for myositis patients
    1. Inclusion body myositis
    2. Cancer diagnosed within the last 2 years
    3. Myositis that is clearly the result of drugs or toxins
  2. Exclusion criteria for normal volunteers
    1. Recognized autoimmune disease
    2. Interstitial lung disease

What will you do?

What sample(s) are currently being collected?

This is a blood, urine and data collection study. A single visit and evaluation is all that is required.

Participants will complete questionnaires about their medical history and the types of exposures they have had at work, at home, and elsewhere. Participants who have myositis will also be asked about certain infections, heavy exercise or physical exertion, sun exposure, tobacco and alcohol use, and stressful events prior to being diagnosed with the disease. Healthy volunteers will be asked about the same exposures before the date of diagnosis of disease of the myositis subject to which they have been matched.

Participants enrolled at their local doctor's office will receive a kit that contains instructions for completing the questionnaires and blood drawing.

All participants will be asked to collect house dust in the bedroom using a special filter that connects to a vacuum cleaner. This dust will be kept for possible future analyses of infectious or toxic agents based on the other results from the study.

Individuals with myositis will have other tests as clinically indicated, including lung function tests and imaging studies.

What will NIEHS do?

The autoimmune disorder myositis weakens the muscles and may cause other health problems. Environmental exposures associated with myositis include ultraviolet radiation, stressful life events and muscle overexertion, collagen implants, infections such as retroviruses and streptococci bacteria, and certain drugs and chemicals. Some individuals with myositis also produce proteins in the blood called autoantibodies that react with certain parts of the person's own cells, called synthetases, which are involved in making new proteins. A syndrome called the anti-synthetase syndrome, which includes myositis and lung disease, is associated with having the anti-synthetase autoantibodies.

Researchers are interested in studying differences in environmental exposures in individuals with myositis. This study is being conducted to determine if persons with the anti-synthetase syndrome have had different environmental exposures before disease onset compared with other patients with myositis who do not have this syndrome and compared with healthy volunteers.

Study Location

Subjects may be enrolled at the NIH Clinical Center, 9000 Rockville Pike, Bethesda, MD, 20892, or at the NIEHS Clinical Research Unit, 111 T.W. Alexander Drive, Research Triangle Park, NC 27709, or in their local health care provider's office. Subjects may also participate via other enrolling centers; please contact below for more information.

Protocol Number: 11-E-0072

Enrollment and Contact Information

Referral/Patient Recruitment
Warren Grant Magnuson Clinical Center
National Institutes of Health
Bethesda, Maryland 20892-2655
Tel 800-411-1222, TTY 866-411-1010
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