Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT01734369
Eligibility Criteria:
* 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 Subjects may be active duty or no longer active duty personnel.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 Subjects may be active duty or no longer active duty personnel.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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01734369
Study Brief:
Protocol Section:
NCT01734369