Environmental Risk Factors for Myositis in Military Personnel
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01734369|
Recruitment Status : Active, not recruiting
First Posted : November 27, 2012
Last Update Posted : May 30, 2023
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- 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.
- To study environmental risk factors for myositis in military personnel.
- Military personnel who developed myositis during their period of service.
- Healthy military personnel who do not have myositis or another autoimmune disease.
- 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.
|Condition or disease|
|Dermatomyositis Adult Polymyositis Inclusion Body Myositis Myositis|
|Study Type :||Observational|
|Actual Enrollment :||37 participants|
|Official Title:||Environmental Risk Factors for the Development of Myositis in Military Personnel|
|Actual Study Start Date :||March 13, 2014|
|Actual Primary Completion Date :||October 31, 2021|
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.
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 [ 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
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01734369
|United States, Maryland|
|Walter Reed National Medical Center|
|Bethesda, Maryland, United States, 20301|
|National Institutes of Health Clinical Center|
|Bethesda, Maryland, United States, 20892|
|United States, North Carolina|
|NIEHS Clinical Research Unit (CRU)|
|Research Triangle Park, North Carolina, United States, 27709|
|Principal Investigator:||Adam I Schiffenbauer, M.D.||National Institute of Environmental Health Sciences (NIEHS)|
|Responsible Party:||National Institute of Environmental Health Sciences (NIEHS)|
|Other Study ID Numbers:||
|First Posted:||November 27, 2012 Key Record Dates|
|Last Update Posted:||May 30, 2023|
|Last Verified:||May 22, 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Plan Description:||.It is not yet known if there will be a plan to make IPD available|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Inclusion Body Myositis
Myositis, Inclusion Body
Nervous System Diseases
Connective Tissue Diseases