DermatomyositisNCT01734369
Environmental Risk Factors for Myositis in Military Personnel
An observational study of Dermatomyositis and Adult Polymyositis, run by National Institute of Environmental Health Sciences (NIEHS) at 7 sites in United States.
Trial summary
Background: Myositis is a rare disease in which the body s immune cells attack the muscle tissue. It can cause muscle weakness, swelling, and pain. It can develop in people with no history of muscle problems. Environmental exposures may determine who develops myositis. Genes may also affect development of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatomyositis, Adult Polymyositis, Inclusion Body Myositis
- How many people
- 37 participants
- Where
- 7 sitesUnited States
- Study dates
- 13 Mar 2014to 31 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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 Subjects may be active duty or no longer active duty personnel.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.
- ELIGIBILITY CRITERIA:
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 Subjects may be active duty or no longer active duty personnel.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 autoimmune 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:
- Diagnosis of myositis during military service or service as a military contractor or civilian working for the military, 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 or civilians working for the military 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.
- Able and willing to give informed consent, to complete the questionnaires and to donate blood samples.
The inclusion criteria for matched controls are:
- Persons with military experience or having served as a military contractor or civilian working for the military 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), gender- race- and age- (within 10 years) and military service period (within 10 years) matched to the myositis subject. 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.
- Controls should be without a recognized autoimmune or chronic muscle disease, able and willing to give informed consent, to complete the questionnaires and to donate blood samples.
The exclusion criteria for all protocol subjects are:
- Medical illness that in the judgment of the investigators does not allow safe blood draws or other clinical evaluations needed for study participation.
- Chronic muscle diseases other than idiopathic inflammatory myopathy (e.g., infectious, dystrophic, metabolic, toxic or drug-induced myopathies).
- Cognitive impairment.
- Not able or willing to give informed consent.
- Age <18 years.
- Current incarceration
There are no gender or ethnic restrictions to enrollment in the study.
HIV is not an exclusion for this study for the two following reasons:
- It has no impact on study procedures or tests.
- HIV may be one of the viral risk factors we are investigating.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Walter Reed National Medical Center
Bethesda, Maryland, 20301
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Miami VA Healthcare System
Miami, Florida, 33125
VA Pittsburgh Healthcare Sys.
Pittsburgh, Pennsylvania
Naval Medical Center, Portsmouth
Portsmouth, Virginia, 23708
NIEHS Clinical Research Unit (CRU)
Research Triangle Park, North Carolina, 27709
Madigan Army Medical Center
Tacoma, Washington, 98431
About this study
Official title: Environmental Risk Factors for the Development of Myositis in Military Personnel
Background:
- Myositis is a rare disease in which the body s immune cells attack the muscle tissue. It can cause muscle weakness, swelling, and pain. It can develop in people with no history of muscle problems. Environmental exposures may determine who develops myositis. Genes may also affect development of the disease.
- Some people who serve in the military develop myositis. However, other military personnel do not. Researchers want to compare military personnel with and without myositis. They will look for common factors that might have led to the disease.
Read more
Objectives:
- To study environmental risk factors for myositis in military personnel.
Eligibility:
- Military personnel who developed myositis during their period of service.
- Healthy military personnel who do not have myositis or another autoimmune disease.
Design:
- Participants will have a physical exam and medical history.
- Participants will fill out forms about environmental exposures, particularly while in the military. The questions will ask about past infections, vaccines and medications, and personal habits. They will also ask about participants occupations during military service and their deployments.
- Participants will also provide blood samples for study.
- No treatment will be provided as part of this study.
Read the detailed description
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.
- Conditions
- Dermatomyositis, Adult Polymyositis, Inclusion Body Myositis, Myositis
- Keywords
- Dermatomyositis, Inclusion Body Myositis, Myositis, Polymyositis, Military, Natural History
- Medical subject headings
- Dermatomyositis, Polymyositis, Myositis, Inclusion Body, Myositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control Subjects | 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. | |
| Myositis Subjects | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Assessed once per respondent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study start13 Mar 2014
- Primary completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DermatomyositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Adam I Schiffenbauer, M.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01734369
- Sponsor's protocol ID
- 130015
- Other IDs
- 13-E-0015
- Status last verified
- 3 Mar 2026
- First submitted
- 22 Nov 2012
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available
Publications
Bacarese-Hamilton T, Mezzasoma L, Ardizzoni A, Bistoni F, Crisanti A. Serodiagnosis of infectious diseases with antigen microarrays. J Appl Microbiol. 2004;96(1):10-7. doi: 10.1046/j.1365-2672.2003.02111.x.
PubMed 14678154Aggarwal R, Lucas M, Fertig N, Oddis CV, Medsger TA Jr. Anti-U3 RNP autoantibodies in systemic sclerosis. Arthritis Rheum. 2009 Apr;60(4):1112-8. doi: 10.1002/art.24409.
PubMed 19333934Bach JF. The effect of infections on susceptibility to autoimmune and allergic diseases. N Engl J Med. 2002 Sep 19;347(12):911-20. doi: 10.1056/NEJMra020100. No abstract available.
PubMed 12239261
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environmental Risk Factors for the Development of Myositis in Military Personnel
- ClinicalTrials.gov ID
- NCT01734369
- Acronym / sponsor ID
- 130015
- Conditions
- Dermatomyositis, Adult Polymyositis, Inclusion Body Myositis, Myositis
- Keywords
- Dermatomyositis, Inclusion Body Myositis, Myositis, Polymyositis, Military, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 13 Mar 2014 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- First posted
- 27 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Myositis is a rare disease in which the body s immune cells attack the muscle tissue. It can cause muscle weakness, swelling, and pain. It can develop in people with no history of muscle problems. Environmental exposures may determine who develops myositis. Genes may also affect development of the disease.
- Some people who serve in the military develop myositis. However, other military personnel do not. Researchers want to compare military personnel with and without myositis. They will look for common factors that might have led to the disease.
Objectives:
- To study environmental risk factors for myositis in military personnel.
Eligibility:
- Military personnel who developed myositis during their period of service.
- Healthy military personnel who do not have myositis or another autoimmune disease.
Design:
- Participants will have a physical exam and medical history.
- Participants will fill out forms about environmental exposures, particularly while in the military. The questions will ask about past infections, vaccines and medications, and personal habits. They will also ask about participants occupations during military service and their deployments.
- Participants will also provide blood samples for study.
- No treatment will be provided as part of this study.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Control Subjects | – | –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. |
| Myositis Subjects | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Military Myositis Questionnaire
Time frame: Assessed once per respondent
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 14678154Bacarese-Hamilton T, Mezzasoma L, Ardizzoni A, Bistoni F, Crisanti A. Serodiagnosis of infectious diseases with antigen microarrays. J Appl Microbiol. 2004;96(1):10-7. doi: 10.1046/j.1365-2672.2003.02111.x.
- Background: PubMed 19333934Aggarwal R, Lucas M, Fertig N, Oddis CV, Medsger TA Jr. Anti-U3 RNP autoantibodies in systemic sclerosis. Arthritis Rheum. 2009 Apr;60(4):1112-8. doi: 10.1002/art.24409.
- Background: PubMed 12239261Bach JF. The effect of infections on susceptibility to autoimmune and allergic diseases. N Engl J Med. 2002 Sep 19;347(12):911-20. doi: 10.1056/NEJMra020100. No abstract available.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam I Schiffenbauer, M.D. principal investigator
National Institute of Environmental Health Sciences (NIEHS)
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatomyositis and Adult Polymyositis, run by National Institute of Environmental Health Sciences (NIEHS) at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Military Myositis Questionnaire (time frame: Assessed once per respondent). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01734369, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.