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Looking at environmental exposures in people with myositis and anti-synthetase syndrome

Compares past exposures in people with myositis, with or without anti-synthetase syndrome, and healthy volunteers.

Key facts

Who runs it
National Institute of Environmental Health Sciences (NIEHS)
Where
Baltimore, Bethesda, Boston, Miami, Pittsburgh, Research Triangle Park, Rochester, and Rockville, United StatesSee the 8 sites
Trial code
Registry title
Environmental Risk Factors for the Anti-synthetase Syndrome
Status
Recruiting
People taking part
580 people, planned
Started
9 Feb 2011
Type of study
Observational, 3 groups
Record updated
16 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with myositis (muscle inflammation), with or without anti-synthetase syndrome, and healthy volunteers without autoimmune disease. It studies past environmental exposures.

Age
2 Years to 100 Years. Children must be older than 2 years.
Sex
All sexes can join.
Disease stage
People with myositis need a diagnosis of possible, probable or definite polymyositis (PM) or dermatomyositis (DM), made within 24 months of joining. Other connective tissue diseases are allowed. Healthy volunteers must have no known autoimmune disease or ILD (lung scarring disease). They are friends, cousins or community volunteers of the same race, sex and similar age as a patient.
Biomarker or test result
People with myositis have a chest X-ray (CXR) to check for lung disease. This sorts them into anti-synthetase positive or negative groups.

Main reasons for not taking part

  • Myositis linked to cancer (cancer found within 2 years of the myositis diagnosis)
  • Inclusion body myositis, or myositis caused by a drug or toxin that went away after stopping it
  • Children less than 2 years of age
  • Cognitive impairment, or an illness that makes blood draws unsafe
  • Not in the US or Canada at the reference date, or currently in prison

The registry criteria, word for word

Show all 20 criteriaShow less

Other criteria

  • INCLUSION CRITERIA:; There are no gender or ethnic restrictions to enrollment in the study. Age restrictions for children do apply to enrollment in the study; The inclusion criteria for enrollment of myositis subjects are:
  • Diagnosis of myositis based on criteria for possible, probable or definite PM or DM, with or without other connective tissue diseases, documented within 24 months of enrollment (using the most recent diagnosis date to define the 24-month period)
  • CXR to assess possible ILD and assign the subject to the presumptive anti-synthetase positive or negative category if clinically indicated
  • Children must be greater than two years of age
  • Able and willing to give informed consent, to complete the questionnaires and to donate blood samples (in case of children greater than 2 years of age but <18 years of age, parent/legal guardian must be willing and able to provide informed consent and child will provide assent according to child s maturity level and understanding); The exclusion criteria for myositis subjects are:
  • Cancer-associated myositis (cancer diagnosed within 2 years of the diagnosis of myositis)
  • Inclusion body myositis
  • Myositis that has clearly developed as the result of a drug, toxin or other exposure and has resolved after discontinuation of the exposure to that agent
  • Children less than 2 years of age; The inclusion criteria for controls are:
  • Friends or, if friends are not available, cousins of the anti-synthetase-positive myositis patient, or, if friends or cousins are not available, volunteers from the general community (such as the NIH Normal volunteer program), race- gender- and age- (within 5 years for minors and within 10 years for adults) matched, and when possible who is living as close as possible to the geographic area of the myositis patient
  • Controls should be without a recognized autoimmune disease or ILD
  • Able and willing to give informed consent, to complete the questionnaires and to donate blood samples (in case of children greater than 2 years of age but <18 years of age, parent/legal guardian must be willing and able to provide informed consent) and child will provide assent according to child maturity level and understanding); The exclusion criteria for all protocol subjects are:
  • Medical illness that in the judgment of the investigators does not allow safe blood draws or other clinical evaluations needed for study participation
  • Cognitive impairment
  • Not able or willing to give informed assent or consent
  • Children less than 2 years of age
  • Patients who at their reference date were not in the US or Canada
  • Individuals currently incarcerated; HIV considerations:; HIV is not an exclusion for affected participants in this study for the two following reasons:
  • It has no impact on study procedures or tests
  • It may be one of the viral risk factors we are investigating

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 2 and 100 years old?

Where in United States

  • Johns Hopkins UniversityBaltimore, United StatesContact: Adam I Schiffenbauer, M.D.No longer taking part
  • National Institutes of Health Clinical CenterBethesda, United StatesContact: NIH Clinical Center Office of Patient Recruitment (OPR)Taking people
  • Brigham and Women's HospitalBoston, United StatesContact: Adam I Schiffenbauer, M.D.No longer taking part
  • University of Miami HospitalMiami, United StatesContact: Adam I Schiffenbauer, M.D.No longer taking part
  • University of PittsburghPittsburgh, United StatesContact: Adam I Schiffenbauer, M.D.No longer taking part
  • NIEHS Clinical Research Unit (CRU)Research Triangle Park, United StatesContact: Adam Schiffenbauer, M.D.Taking people
  • Mayo Clinic - RochesterRochester, United StatesContact: Adam I Schiffenbauer, M.D.No longer taking part
  • Mid-Atlantic Kaiser PermanenteRockville, United StatesContact: Adam I Schiffenbauer, M.D.No longer taking part

About the trial

What the trial wants to find out

Background:

Read full original descriptionShow less

* 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 also compared with healthy volunteers.

Objectives:

- 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.

Eligibility:

- Individuals who have been diagnosed with myositis (with or without anti-synthetase autoantibodies), and healthy volunteers without autoimmune disorders.

Design:

* Participants will be screened with a full medical history and physical examination, and will provide blood, urine and house dust samples. * 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 will receive a kit that contains instructions and a filter to be put onto their vacuum cleaner to collect house dust in the bedroom. 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.

The 3 groups in the trial

  • Antisynthetase Negative

    Subjects with myositis without antisynthetase syndrome

  • Antisynthetase Positive

    Subject with myositis with antisynthetase syndrome

  • Healthy Control

    Subjects without autoimmune disease

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Environmental Risk Factors for the Anti-Synthetase Syndrome
Plain-language title
Looking at environmental exposures in people with myositis and anti-synthetase syndromeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT01276470, who can take part
Record updated
16 October 2026
Environmental Risk Factors for the Anti-synthetase Syndrome (NCT01276470) – Frontlight Research