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Environmental Risk Factors for the Anti-synthetase Syndrome

The MYORISK Study – 11-E-0072

Study Design
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.

 

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.

 

Purpose
To determine whether selected infectious and noninfectious environmental exposures are more common in individuals who have myositis with the anti-synthetase syndrome, compared with healthy volunteers.

 

Subject
Subjects with myositis and healthy volunteers

 

Number of subjects

  1. 150 myositis patients with the anti-synthetase syndrome
  2. 150 age- and sex-matched healthy controls that are ideally friends or cousins of the anti-synthetase syndrome patients and living in the same geographic area
  3. 150 myositis patients without the anti-synthetase syndrome

 

Overview of the Study and Evaluations
This is a blood, urine and data collection study and subjects may be enrolled at the NIH Clinical Center in Bethesda, MD, in the NIEHS Clinical Research Unit in Research Triangle Park, NC, or in their local health care provider's office. 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.

 

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

 

Population Exclusion(s)
None

 

Eligibility Criteria

  1. 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 12 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.
  2. 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

 

Treatment Intervention
None

 

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

  1. Consent for patients
  2. Consent for healthy volunteers or parents of healthy minors
  3. Assent for minor patient or healthy volunteer

 

Consent for Patients

 

Study Sites
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.

 

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
Irene.whitt@nih.gov
Frederick W. Miller, M.D., Ph.D. (http://www.niehs.nih.gov/research/clinical/ea/index.cfm)
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
millerf@mail.nih.gov

 
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
riderl@mail.nih.gov
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
prpl@mail.cc.nih.gov

 

Other Contact

Tasia Long
MYORISK Protocol Coordinator
NIH, Warren Grant Magnuson Clinical Center
10 Center Drive, Bldg. 10, Room 6C432A, MSC 1627
Bethesda, Maryland 20892-1627
Tel (301) 451-6031
Fax (301) 451-5731
longtm@mail.nih.gov

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