Natural History of Inflammatory Muscle Diseases

Status: Recruiting
Location: See location...
Study Type: Observational
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. * Genetic testing. Some of the samples collected may be used for genetic testing.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 120
Healthy Volunteers: t
View:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:

• 1\. Ability of subject, or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent and/or assent document.

• 2a. Patients are adults and minors of age 12 or older, with possible inflammatory myopathy (suspected or confirmed)

• OR

• 2b. Healthy volunteers will be adults aged 18 or older.

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Julie G Thompson, R.N.
julie.thompson@nih.gov
(301) 480-3191
Backup
Andrew L Mammen, M.D.
andrew.mammen@nih.gov
(301) 594-6667
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2032-02-25
Participants
Target number of participants: 500
Treatments
Healthy Volunteers
18 years old and up
Patients
greater than 12 years
Related Therapeutic Areas
Sponsors
Leads: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

This content was sourced from clinicaltrials.gov