ClinicalTrials.gov record NCT01276470

Environmental Risk Factors for the Anti-synthetase Syndrome

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Oct 10, 2026

Environmental Risk Factors for the Anti-Synthetase Syndrome

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age2 years old to 100 years old
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This observational case-control study compares people with recent-onset myositis who have the anti-synthetase syndrome, people with recent-onset myositis without the syndrome, and matched healthy volunteers. Participants provide medical history and complete exposure questionnaires, and give blood, urine, and house dust samples. Clinically indicated tests (for example lung imaging or lung function tests) may be done for participants with myositis.

What it is studying. The study is looking for differences in prior environmental exposures (noninfectious and infectious) between people with the anti-synthetase syndrome, other myositis patients, and matched healthy controls. It also tests whether certain infectious agents are detected more often in samples from anti-synthetase patients.

What the researchers hope to learn. 1) Determine whether selected noninfectious environmental exposures are more common before disease onset in 150 recent-onset myositis patients with the anti-synthetase syndrome compared with 150 matched controls without autoimmune disease and with 150 recent-onset myositis patients without the syndrome. 2) Determine whether selected infectious agents can be detected more frequently in blood (and in biopsy samples when available) from recent-onset anti-synthetase patients compared with matched controls and with recent-onset myositis patients without anti-synthetase syndrome.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

Background:

  • 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.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

Most autoimmune diseases are thought to develop as a result of chronic immune activation and dysregulation after selected environmental exposures in genetically susceptible individuals. Based on prior studies suggesting roles for noninfectious and infectious agents in the development of myositis, as well as the known clinical, epidemiologic and genetic differences among phenotypes, we hypothesize that different myositis phenotypes are triggered by different environmental exposures in genetically susceptible individuals. One phenotype that is particularly well-defined clinically and genetically, and for which environmental triggers are likely, is myositis associated with anti-synthetase autoantibodies (defined as the anti-synthetase syndrome). These patients have an acute myositis onset in the spring of the year and also tend to develop fevers, elevated white blood cell counts, arthritis and interstitial lung disease. Although these features are consistent with an environmental trigger for the anti-synthetase syndrome, and although case reports and animal models suggest infectious or noninfectious agents may play a role, no study has systematically assessed environmental agents in this population. In collaboration with multiple centers, we plan to test the hypothesis that certain environmental exposures are associated with the anti-synthetase syndrome and differ from those seen in matched controls and in myositis patients without the anti-synthetase syndrome. The specific aims of this study are to: 1) determine whether selected noninfectious environmental exposures are more common preceding disease onset in 150 recent-onset (defined as within 24 months of meeting criteria for possible, probable or definite myositis) myositis patients with the anti-synthetase syndrome, compared with 150 control subjects without autoimmune disease (1:1 matched with the patients), and compared with 150 recent-onset myositis patients without the anti-synthetase syndrome; and 2) determine whether selected infectious agents can be detected more frequently in blood samples of recent-onset anti-synthetase syndrome patients compared with matched controls, and in blood or biopsy samples from recent-onset anti-synthetase myositis patients compared with recent-onset myositis patients without the anti-synthetase syndrome. Medical histories, concurrent conditions and environmental questionnaire information will be collected from all participants. Subjects will undergo a clinical, laboratory and immunologic assessment to document current diagnoses, disease manifestations and severity. A chest x-ray, high resolution computed tomography (HRCT) of the chest, pulmonary function tests, bronchoalveolar lavage, and muscle and lung biopsies will be performed as clinically indicated. Blood DNA and RNA sera, biopsy and house dust repositories will be created for current and future investigations.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

You will have a medical history and physical exam and complete questionnaires about medical history and environmental exposures; healthy volunteers are asked about exposures before the matched myositis patient's diagnosis. You will give blood and urine samples and receive a kit with a filter to collect bedroom house dust with your vacuum for the study. People with myositis may also have clinical tests as needed, which can include chest x-ray, high-resolution chest CT, lung function tests, bronchoalveolar lavage, and muscle or lung biopsies. Blood (DNA, RNA, serum), biopsy material and house dust samples will be stored in repositories for current and future research.

How the study is structured. This is an observational, cross-sectional case-control study. Three groups are compared: anti-synthetase-positive myositis patients, anti-synthetase-negative myositis patients, and matched healthy controls. Participants complete questionnaires about past exposures and medical history, provide blood and urine samples, and collect house dust using a provided vacuum filter kit; some myositis patients may have additional clinically indicated tests or imaging. Samples and data are stored for current and possible future analyses.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on polymyositis

This trial is also listed on this site under anti-synthetase syndrome and dermatomyositis.

Clinical trials55 trials listed for polymyositisEvery trial the registry lists for polymyositis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in polymyositis researchLatest monthly update: September 2026. Includes: CD4 count risk. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Feb 9, 2011
Target enrollment
580 participants (estimated)
Last updated on registry
Oct 8, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
National Institute of Environmental Health Sciences (NIEHS)

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (8)

  • University of Miami HospitalWithdrawn

    Miami, Florida, 33101 · United States

  • Johns Hopkins UniversityCompleted

    Baltimore, Maryland, 21205 · United States

  • National Institutes of Health Clinical CenterRecruiting

    Bethesda, Maryland, 20892 · United States

  • Mid-Atlantic Kaiser PermanenteCompleted

    Rockville, Maryland, 20853 · United States

  • Brigham and Women's HospitalCompleted

    Boston, Massachusetts, 02115 · United States

  • Mayo Clinic, RochesterCompleted

    Rochester, Minnesota, 55905 · United States

  • NIEHS Clinical Research Unit (CRU)Recruiting

    Research Triangle Park, North Carolina, 27709 · United States

  • University of PittsburghCompleted

    Pittsburgh, Pennsylvania, 15261 · United States

Terms used on this page · explanations by MedicalUpdates.ai

enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
inclusion criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
legal guardian
A person who is legally allowed to make decisions, including consent to research, on behalf of someone who cannot consent for themselves.
assent
A child's or dependent adult's agreement to take part, given alongside the formal consent of a parent or legal representative.
exclusion criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
1:1
How many participants go to each group. In a 2:1 ratio, two are assigned to the first group for every one assigned to the second.
biopsy
Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
computed tomography
An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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