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NCT01276470 · ClinicalTrials.gov registry record

Environmental Risk Factors for the Anti-synthetase Syndrome

A clinical trial of Dermatomyositis and Polymyositis, sponsored by National Institute of Environmental Health Sciences (NIEHS).

Recruiting
Registry status
580
Enrollment target
8
Study locations

NCT01276470 is a study of Dermatomyositis and Polymyositis that is actively recruiting participants, run by National Institute of Environmental Health Sciences (NIEHS). The registered enrollment target is 580 participants, above the 454-participant average among 19 other Dermatomyositis trials with a reported enrollment target (28% higher). The trial reports 8 study locations across 6 states.

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The verdict

NCT01276470, a study of Dermatomyositis and Polymyositis, is actively recruiting participants, sponsored by National Institute of Environmental Health Sciences (NIEHS).

RECRUITING
Registry status
580 participants
Enrollment target
8
Study locations

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.

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

FieldValue
Enrollment Target 580 participants
Start Date 2011-02-09

What the Registry Record Tells You About NCT01276470

The ClinicalTrials.gov registry entry for NCT01276470 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 580 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 454-participant average among 19 other Dermatomyositis trials with a reported enrollment target (28% higher). The listed sponsor is National Institute of Environmental Health Sciences (NIEHS), which has 145 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Dermatomyositis appearing as the primary indexed condition, and to 0 interventions.

NCT01276470 reports 8 study locations spanning 6 distinct geographic areas - top geographies include Maryland, Florida, Massachusetts.

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.

Who is sponsoring clinical trial NCT01276470?

This trial is sponsored by National Institute of Environmental Health Sciences (NIEHS), which has 145 total clinical trials registered on ClinicalTrials.gov.

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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