NCT05738824

Natural History of Inflammatory Muscle Diseases

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · NIH
• Sex: All
• Age: 12 Years – 120 Years
• Healthy volunteers: Accepted

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.

Detailed description

Study Description: This is an observational study to characterize the different types of inflammatory myopathies, understand their etiology, pathogenesis, prognosis, and response to different treatments. Objectives: Primary objective: Define the different types of inflammatory muscle diseases, their etiology, pathogenesis, prognostic factors, and response to different treatments. Secondary objectives: Study different diagnostic modalities that may help to diagnose and monitor the evolution of the disease in patients with myositis. Endpoints: Primary endpoint: Severity of muscle, skin, pulmonary, and joint involvement. Study of the immune dysregulation, transcriptomic changes, and genetic modifications in patients with inflammatory muscle diseases. Secondary endpoints: Utility of standard of care laboratory, radiologic, electrophysiologic, and clinical studies to diagnose and monitor the evolution of the disease in patients with myositis.

Conditions

• Inflammation In Skeletal Muscle

Timeline

• Start date: 2023-06-01
• Primary completion: 2032-02-25
• Completion: 2032-02-25
• First posted: 2023-02-22
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States