RecruitingNCT05738824

Natural History of Inflammatory Muscle Diseases


Sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Enrollment

500 participants

Start Date

Jun 1, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

Objective: To collect information and biospecimens (such as blood, muscle, and skin samples) that will be used to research causes and treatments of inflammatory muscle diseases. Eligibility: People aged 12 years and older with suspected or confirmed inflammatory muscle disease. Healthy volunteers aged 18 years and older are also needed. Design: Participants will have at least 1 clinic visit. Each visit will last 4 to 8 hours. Some may return for additional visits. All participants will undergo these procedures (unless they are unable to): * Physical exam, including blood and urine tests. * Magnetic resonance imaging (MRI) scan of the thigh. Participants will lie still on a table with padding around 1 thigh. The table will slide into a tube. The scan will last for approximately 40 minutes. Some procedures are optional: * Muscle biopsy: An area of skin will be numbed. A quarter-inch cut will be made. Several pieces of muscle tissue, about the size of grains of rice, will be removed. * Skin biopsy: An area of skin will be numbed. A piece of skin about a quarter inch in diameter will be removed. * Lymph node biopsy: A small sample of fluid or tissue from a lymph node will taken to check for infection. * Genetic testing. Some of the samples collected may be used for genetic testing.


Eligibility

Min Age: 12 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This is a natural history study — meaning it follows people over time without giving any experimental treatment — focused on inflammatory muscle diseases, collectively called inflammatory myopathies. These are rare autoimmune conditions where the immune system mistakenly attacks muscle tissue, causing weakness, fatigue, and sometimes damage to other organs like the lungs and skin. Conditions included are polymyositis, dermatomyositis, and related disorders. By collecting clinical data, biosamples, and assessments over time, researchers aim to better understand how these diseases progress and what factors predict outcomes. Adults and young people aged 12 and older with possible or confirmed inflammatory myopathy are eligible, as are healthy adult volunteers (18 and older) for comparison. The only exclusion criterion is unwillingness to participate or provide research samples — making this a broadly accessible study. Participants attend periodic study visits where clinical assessments, blood draws, and other measurements are collected. No experimental treatments are administered. This research is vital because inflammatory myopathies are poorly understood, often misdiagnosed, and can be difficult to treat. Long-term, detailed natural history data is essential for developing better diagnostic tests, identifying new treatment targets, and designing future clinical trials.

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(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT05738824