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Environmental Risk Factors for the Anti-synthetase Syndrome
NCT01276470 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Study Locations (8)
Maryland
- Johns Hopkins University — Baltimore
- National Institutes of Health Clinical Center — Bethesda
- Mid-Atlantic Kaiser Permanente — Rockville
Florida
- University of Miami Hospital — Miami
Massachusetts
- Brigham and Women's Hospital — Boston
Minnesota
- Mayo Clinic, Rochester — Rochester
North Carolina
- NIEHS Clinical Research Unit (CRU) — Research Triangle Park
Pennsylvania
- University of Pittsburgh — Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 580 participants |
| Start Date | 2011-02-09 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01276470
The ClinicalTrials.gov registry entry for NCT01276470 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 580 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Environmental Health Sciences (NIEHS), which has 75 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Dermatomyositis appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01276470 reports 8 study locations spanning 6 distinct geographic areas — top geographies include Maryland, Florida, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01276470 about?
NCT01276470 is a clinical study titled "Environmental Risk Factors for the Anti-synthetase Syndrome". 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 crea...
What is the current status of trial NCT01276470?
This trial is currently recruiting. The enrollment target is 580 participants. The study started on 2011-02-09.
What conditions does trial NCT01276470 study?
This clinical trial studies the following conditions: Dermatomyositis, Polymyositis, Myositis, Juvenile Dermatomyositis, Juvenile Polymyositis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT01276470?
This trial is sponsored by National Institute of Environmental Health Sciences (NIEHS), which has 75 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01276470 being conducted?
This trial has 8 study locations across Florida, Maryland, Massachusetts, Minnesota, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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