Recruiting

Observational Study

Sponsor:

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

Code:

NCT05738824

Conditions

Inflammation In Skeletal Muscle

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Accepted

Study Details

Brief 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 2 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.

Conditions

Inflammation In Skeletal Muscle

Study ID

NCT05738824

Start date

Jun 1, 2023

Status verified date

Jun 24, 2026

Completion date

Feb 25, 2032

Anticipated

Primary completion date

Feb 25, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Accepted

  • INCLUSION CRITERIA:

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 2 or older, with possible inflammatory myopathy (suspected or confirmed)

OR

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

EXCLUSION CRITERIA:

1\. Unwilling to participate in research studies or to provide research samples or data.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy Volunteers

18 years old and up

Patients

greater than 2 years old

Primary outcome measure

  • Define the different types of inflammatory muscle diseases, their etiology, pathogenesis, prognostic factors, and response to different treatments. [ Time Frame: End of each visit ]

Central Contacts and Locations

Central contacts

Julie G Thompson, R.N.

(301) 480-3191julie.thompson@nih.gov

Andrew L Mammen, M.D.

(301) 594-6667andrew.mammen@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

NIH Clinical Center Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

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

Last update posted

Jun 26, 2026

Last verified

Jun 24, 2026

Keywords

  • Polymyositis
  • Dermatomyositis
  • Childhood Dermatomyositis
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) on 2026-06-26.