Investigating environmental factors linked to anti-synthetase syndrome

Environmental Risk Factors for the Anti-Synthetase Syndrome

This study is trying to see if certain environmental factors, like infections or other triggers, might play a role in causing anti-synthetase syndrome in people with myositis.

Quick facts

• Study type: Observational
• Enrollment: 580 (estimated)
• Ages: 2 Years to 100 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Drugs / interventions: radiation
• Locations: 8 sites (Miami, Florida and 7 other locations)
• Trial ID: NCT01276470 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with myositis, particularly those with anti-synthetase autoantibodies, aged two years and older.

Not a fit: Patients without a diagnosis of myositis or those who do not produce anti-synthetase autoantibodies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better understanding and management of anti-synthetase syndrome, potentially improving patient outcomes.

How similar studies have performed: While there have been case reports and animal models suggesting environmental triggers for myositis, this study represents a systematic approach that has not been previously tested.

Eligibility criteria

* 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 this trial is running

Miami, Florida and 7 other locations

• University of Miami Hospital — Miami, Florida, United States (Withdrawn)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

Conditions Myositis; Dermatomyositis; Polymyositis; Juvenile Dermatomyositis; Juvenile Polymyositis; Adult and Pediatric Autoimmune Disease; Antibody; Autoimmune Diseases