An observational study in Dermatomyositis, Adult Polymyositis and Inclusion Body Myositis, sponsored by National Institute of Environmental Health Sciences (NIEHS). Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by National Institute of Environmental Health Sciences (NIEHS) · Observational
Background:
Objectives:
- To study environmental risk factors for myositis in military personnel.
Eligibility:
Design:
Myositis, an autoimmune muscle disease, likely develops as a result of environmental exposures in genetically susceptible persons. Preliminary data suggest a trend for an increasing incidence in myositis in military personnel over the last decade for unknown reasons. Although a few environmental exposures have been preliminarily associated with myositis in the civilian population, these have not been confirmed. In addition, no study has assessed exposures that might result in the development of myositis in military personnel. Military personnel experience a number of intense, unique exposures, often over a relatively short interval, which include different stresses, novel vaccines, distinct occupational exposures, battlefield injuries and unique chemicals during field deployment, that differ from those exposures in non-military populations. Therefore, we propose a protocol that consists of three complementary approaches to attempt to determine the environmental factors associated with the development of myositis in active duty military personnel and an initial understanding of the possible mechanisms involved. In the first approach, we will assess risk factors in a case-control study of 300 patients who developed myositis while on active duty by comparing them to 1500 active duty military personnel (randomly selected, but matched 5:1 by gender, race, and age and military service within 10 years) who have not been diagnosed with an autoimmune disease or chronic muscle disease. For this first approach, we will analyze existing military databases for information on medications, vaccines, infections, co-existing medical conditions, military occupations, deployments, and worldwide active duty locations. In the second case-control approach, we will attempt to define environmental factors associated with the development of myositis that developed in military personnel (n=150) by comparing them to 150 similarly matched military personnel who have not been diagnosed with an autoimmune disease or chronic muscle disease. This second approach will differ from the first approach, in that subjects will be prospectively enrolled and assessed during a single clinic visit to confirm diagnoses and examine patient questionnaires on focused environmental exposures, including those not captured in the military databases. A third laboratory approach will identify, in an exploratory study, the global DNA methylation epigenetic changes, microRNA and mRNA profiles in peripheral blood and muscle tissues from 18 subjects (six PM and six DM compared to six non-myositis controls enrolled in the second approach) and assess the effects of selected environmental exposures on these parameters. These complementary approaches should enhance the understanding of environmental factors and possible mechanisms associated with the development of myositis in the military, and provide insights into environmental risk factors that may also be relevant to the development of myositis in non-military populations.
184 studies on the registry are indexed under Dermatomyositis; 63 are open to participants now.
This study's enrollment of 37 is below the median of 179 across 45 observational studies indexed under Dermatomyositis.
Browse Dermatomyositis studies →National Institute of Environmental Health Sciences (NIEHS) is the lead sponsor of 183 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Myositis patients include diagnosis of myositis during military service or service as a military contractor based on criteria for probable or definite PM or DM, or clinically or pathologically defined or possible IBM. Subjects may be active duty or no longer active duty personnel. Military contractors include those with at least 1 year of collective service on a military base or who actively deployed with military units after October 1998 and developed myositis will be eligible for this study. Control subjects include persons with military experience or having served as a military contractor attending the same clinic or hospital as the myositis subject to which they are matched, or if not available, volunteers from the general community (such as other participating military or VA hospitals, private HCPs, or the NIH healthy volunteer program), matched to the myositis subject.
For Aim 1 of the study:
The inclusion criteria for myositis subjects are:
-Diagnosis of PM, DM or IBM during military service. Subjects may be active duty or no longer active duty personnel. A matrix diagnosis of myositis will be based on ICD-9 codes, laboratory tests and medical records in an attempt to match criteria for probable or definite PM, DM or IBM
The inclusion criteria for matched control subjects are:
-The same gender, race, age within 10 years, and service in the military within 10 years as the myositis subject.
The exclusion criteria for control subjects are:
-A matrix diagnosis of or chronic muscle disease based on ICD-9 codes and medical records.
For Aims 2 and 3 of the study:
The inclusion criteria for enrollment of myositis subjects are:
The inclusion criteria for matched controls are:
The exclusion criteria for all protocol subjects are:
There are no gender or ethnic restrictions to enrollment in the study.
is not an exclusion for this study for the two following reasons:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Military service members active duty or no longer in duty, military contractors, and civilians working for the military. Controls should be without a recognized autoimmune or chronic muscle disease.
Diagnosis of myositis during military service or service as a military contractor or civilian working for the military with polymyositis, dermatomyositis, or inclusion body myositis.
Military Myositis Questionnaire
Myositis and control subjects will complete the environmnetal exposure questionnaire, a connective tissue screening questionnaire and the Patient Reported Outcomes Measurement Information System (PROMIS) Quality of Life measure to assess health related quality of life
Time frame: Assessed once per respondent
Plan to share: Undecided — It is not yet known if there will be a plan to make IPD available
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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