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NCT Number: NCT05738824

Natural History of Inflammatory Muscle Diseases

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.

Recruiting

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Key information

Conditions

Inflammation In Skeletal Muscle Connective Tissue Diseases Dermatomyositis Muscular Diseases Musculoskeletal Diseases Myositis Nervous System Diseases Neuromuscular Diseases Polymyositis Skin Diseases Skin and Connective Tissue Diseases

Age range

2 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location status: Recruiting

Location contact

NIH Clinical Center Office of Patient Recruitment (OPR)

CONTACT

[email protected]

800-411-1222 ext. TTY dial 711

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • INCLUSION CRITERIA:

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

  • 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

  • Unwilling to participate in research studies or to provide research samples or data.

Treatment and study plan

Primary outcomes

  1. Define the different types of inflammatory muscle diseases, their etiology, pathogenesis, prognostic factors, and response to different treatments.

    Time frame: End of each visit

    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 outcomes

  1. Study different diagnostic modalities that may help to diagnose and monitor the evolution of the disease in patients with myositis.

    Time frame: at baseline

    Utility of standard of care laboratory, radiologic, electrophysiologic, and clinical studies to diagnose and monitor the evolution of the disease in patients with myositis.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew L Mammen, M.D.

CONTACT

[email protected]

(301) 594-6667

Julie G Thompson, R.N.

CONTACT

[email protected]

(301) 480-3191

Sponsors and collaborators

Lead sponsor

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

Nih

Registry information

Important dates

Study start
2023
Primary completion
2032
Study completion
2032
First posted
Feb 22, 2023
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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