NCT01734369

Brief 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.
  • 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
1.3 years until next milestone

Study Start

First participant enrolled

March 13, 2014

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
Last Updated

June 5, 2026

Status Verified

March 3, 2026

Enrollment Period

7.6 years

First QC Date

November 22, 2012

Last Update Submit

June 4, 2026

Conditions

MyositisInclusion Body MyositisAdult PolymyositisDermatomyositis

Keywords

DermatomyositisInclusion Body MyositisMyositisPolymyositisMilitaryNatural History

Outcome Measures

Primary Outcomes (1)

  • 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

    Assessed once per respondent

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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 same gender, race, age within 10 years, and service in the military within 10 years as the myositis subject.

You may not qualify if:

  • 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:
  • 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.
  • 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.
  • 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.
  • It has no impact on study procedures or tests.
  • HIV may be one of the viral risk factors we are investigating.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Miami VA Healthcare System

Miami, Florida, 33125, United States

Location

Walter Reed National Medical Center

Bethesda, Maryland, 20301, United States

Location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

NIEHS Clinical Research Unit (CRU)

Research Triangle Park, North Carolina, 27709, United States

Location

VA Pittsburgh Healthcare Sys.

Pittsburgh, Pennsylvania, United States

Location

Naval Medical Center, Portsmouth

Portsmouth, Virginia, 23708, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

Related Publications (3)

  • 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.

    PMID: 14678154BACKGROUND

  • Aggarwal 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.

    PMID: 19333934BACKGROUND

  • Bach 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.

    PMID: 12239261BACKGROUND

Related Links

MeSH Terms

Conditions

DermatomyositisPolymyositisMyositis, Inclusion BodyMyositis

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Adam I Schiffenbauer, M.D.

    National Institute of Environmental Health Sciences (NIEHS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2012

First Posted

November 27, 2012

Study Start

March 13, 2014

Primary Completion

October 31, 2021

Last Updated

June 5, 2026

Record last verified: 2026-03-03

Locations

US(7)