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Recruiting No phase listed Observational Accepts healthy volunteers

Environmental Risk Factors for the Anti-synthetase Syndrome

ClinicalTrials.gov ID: NCT01276470

Public ClinicalTrials.gov record NCT01276470. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 3:39 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Environmental Risk Factors for the Anti-Synthetase Syndrome

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01276470
Recruitment status
Recruiting
Study type
Observational
Phase
Not listed
Enrollment
580 participants

Conditions and interventions

Eligibility (public fields only)

Age range
2 Years to 100 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 8, 2011
Primary completion
Not listed
Completion
Not listed
Last update posted
Jun 11, 2026

Started 2011

United States locations

U.S. sites
8
U.S. states
6
U.S. cities
8
Facility City State ZIP Site status
University of Miami Hospital Miami Florida 33101 Withdrawn
Johns Hopkins University Baltimore Maryland 21205 Completed
National Institutes of Health Clinical Center Bethesda Maryland 20892 Recruiting
Mid-Atlantic Kaiser Permanente Rockville Maryland 20853 Completed
Brigham and Women's Hospital Boston Massachusetts 02115 Completed
Mayo Clinic, Rochester Rochester Minnesota 55905 Completed
NIEHS Clinical Research Unit (CRU) Research Triangle Park North Carolina 27709 Recruiting
University of Pittsburgh Pittsburgh Pennsylvania 15261 Completed

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01276470, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 11, 2026 · Synced Sep 6, 2026

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