Investigating environmental factors linked to anti-synthetase syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore the relationship between environmental exposures and the development of anti-synthetase syndrome in patients with myositis. It will assess various environmental factors, including infectious agents and non-infectious triggers, in genetically susceptible individuals. The study will involve multiple centers and compare the environmental exposures of patients with anti-synthetase syndrome to matched controls and other myositis patients. By systematically evaluating these factors, the research seeks to identify potential triggers for this autoimmune condition.

Why it matters

Who can join: the full rules

* 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.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting
• NIEHS Clinical Research Unit (CRU)
  Research Triangle Park, North Carolina, United States Recruiting
• University of Miami Hospital
  Miami, Florida, United States Withdrawn
• Johns Hopkins University
  Baltimore, Maryland, United States Completed
• Mid-Atlantic Kaiser Permanente
  Rockville, Maryland, United States Completed
• Brigham and Women's Hospital
  Boston, Massachusetts, United States Completed

Study contacts

• Principal investigator: Adam I Schiffenbauer, M.D. — National Institute of Environmental Health Sciences (NIEHS)
• Study coordinator: Adam I Schiffenbauer, M.D.
• Email: schiffenbauera2@mail.nih.gov
• Phone: (301) 451-6270

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.