Could your environment trigger this rare muscle disease?
NCT ID NCT01276470
First seen Jun 26, 2026 · Last updated Sep 21, 2026 · Updated 2 times
Summary
This study investigates whether certain environmental exposures—like infections, stress, or sun exposure—are more common in people with anti-synthetase syndrome, a rare autoimmune condition that causes muscle weakness and lung disease. Researchers will compare 580 participants, including myositis patients with and without the syndrome, and healthy volunteers. Participants complete questionnaires and provide blood, urine, and house dust samples to identify potential triggers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could help identify environmental triggers for anti-synthetase syndrome, potentially guiding future prevention strategies.
- What could go wrong
- This is an observational study, not a treatment trial. It may not find clear links, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 580 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2011
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
General population; There are no gender or ethnic restrictions to enrollment in the study. Age restrictions for children do apply to enrollment in the study.@@@@@@
- Ages
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2 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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: 1. 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). 2. CXR to assess possible ILD and assign the subject to the presumptive anti-synthetase positive or negative category if clinically indicated. 3. Children must be greater than two years of age. 4. 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: 1. Cancer-associated myositis (cancer diagnosed within 2 years of the diagnosis of myositis). 2. Inclusion body myositis. 3. 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. 4. Children less than 2 years of age. The inclusion criteria for controls are: 1. 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. 2. Controls should be without a recognized autoimmune disease or ILD. 3. 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: 1. Medical illness that in the judgment of the investigators does not allow safe blood draws or other clinical evaluations needed for study participation. 2. Cognitive impairment. 3. Not able or willing to give informed assent or consent. 4. Children less than 2 years of age. 5. Patients who at their reference date were not in the US or Canada 6. Individuals currently incarcerated HIV considerations: HIV is not an exclusion for affected participants in this study for the two following reasons: 1. It has no impact on study procedures or tests. 2. It may be one of the viral risk factors we are investigating.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Brigham and Women's Hospital
COMPLETEDBoston, Massachusetts, 02115, United States
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Johns Hopkins University
COMPLETEDBaltimore, Maryland, 21205, United States
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Mayo Clinic, Rochester
COMPLETEDRochester, Minnesota, 55905, United States
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Mid-Atlantic Kaiser Permanente
COMPLETEDRockville, Maryland, 20853, United States
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NIEHS Clinical Research Unit (CRU)
RECRUITINGResearch Triangle Park, North Carolina, 27709, United States
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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University of Miami Hospital
WITHDRAWNMiami, Florida, 33101, United States
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University of Pittsburgh
COMPLETEDPittsburgh, Pennsylvania, 15261, United States
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- Can better sleep ease pain in teens with rheumatic disease?