RecruitingNCT00017914

Adult and Juvenile Myositis

Studies in the Natural History and Pathogenesis of Childhood-Onset and Adult-Onset Idiopathic Inflammatory Myopathies


Sponsor

National Institute of Environmental Health Sciences (NIEHS)

Enrollment

1,200 participants

Start Date

Jun 7, 1995

Study Type

OBSERVATIONAL

Conditions

Summary

This study will evaluate subjects with adult- and childhood-onset myositis to learn more about their cause and the immune system changes and medical problems associated with them. Myositis is an inflammatory muscle disease that can damage muscles and other organs, resulting in significant disability. Children or adults with polymyositis or dermatomyositis or a related condition may be evaluated under this study. Healthy children or adults will also be enrolled as "controls," for comparison of test results. All patients will undergo a complete history (including completing some questionnaires) and physical examination, review of medical records, and blood and urine tests. Patients may then choose to participate in an additional 1- to 5-day evaluation, which will include some or all of the following diagnostic, treatment or research procedures: 1. Standardized muscle strength testing, range of motion of joints and walking (gait) analysis by a physiotherapist; completion of a questionnaire regarding ability to perform daily tasks 2. Skin assessment, possibly including photographs of lesions and a skin biopsy (removal of a small skin sample under local anesthetic) 3. Magnetic resonance imaging (scans that use magnetic fields to visualize tissues) of leg muscles 4. Swallowing studies, including a physical examination and questionnaire on swallowing ability, studies of tongue strength, and ultrasound imaging during swallowing, and possibly, a modified barium swallow 5. Voice and speech assessment, possibly including computerized voice analysis and laryngoscopy-analysis of the larynx (voice box) using a small rigid scope with a camera placed in the mouth to view and record vocal cord function 6. Pulmonary function tests (measurement of air moved into and out of the lungs, using a breathing machine) to evaluate lung function and, possibly, chest X-ray 7. Electrocardiogram (measurement of the electrical activity of the heart) and, possibly, echocardiogram (ultrasound imaging of the heart) 8. Endocrine evaluation 9. Eye examination, in patients with vision loss or other eye symptoms 10. Nutrition assessment to evaluate muscle mass and muscle wasting, including tape measurements or bioelectric impedance testing, a painless procedure in which wires are attached to the extremities with a sticky paste. 11. Muscle ultrasound. 12. Electromyography (record of the electrical activity of muscles) 13. Muscle or skin biopsy (removal of a small piece of muscle tissue for microscopic examination) All patients may have only a one-time evaluation or may return for one follow-up evaluations (either the 1-day or 3- to 5-day evaluation) over a 1-year period. Healthy children will undergo a medical history and brief physical examination; blood and urine tests; speech and swallowing studies including questionnaires and physical examination, tongue strength, and ultrasound study; and bioelectric impedance testing. Children 8 to 18 years old may also have exercise testing.


Eligibility

Min Age: 2 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study investigates adult and juvenile inflammatory myositis — a group of rare autoimmune diseases where the immune system attacks muscle tissue, causing muscle weakness, fatigue, and sometimes skin rashes. Types include polymyositis, dermatomyositis, and inclusion body myositis. The goal is to identify biomarkers, understand disease mechanisms, and develop better therapies. You may be eligible if: - You are between 2 and 100 years of age - You have a documented diagnosis of an idiopathic inflammatory myopathy (such as dermatomyositis, polymyositis, or inclusion body myositis), or a related condition - You have symptoms suggestive of myositis (e.g., muscle weakness, skin rash, elevated CK levels) and need evaluation - Healthy volunteers matched for age and gender are also eligible You may NOT be eligible if: - You are under 2 or over 100 years of age - Your medical condition makes the required blood draws or procedures medically inappropriate - (Healthy volunteers) You have had surgery or major trauma in the past 2 months, are currently on anti-inflammatory medications, or have a chronic illness such as inflammatory disease, cancer, or cardiac/pulmonary disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(4)

Emory University

Atlanta, Georgia, United States

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

NIEHS Clinical Research Unit (CRU)

Research Triangle Park, North Carolina, United States

Texas Scottish Rite Hospital

Dallas, Texas, United States

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NCT00017914


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