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NCT05738824From ClinicalTrials.govRecruiting

Natural History of Inflammatory Muscle Diseases

  • Inflammation In Skeletal Muscle

At a glance

Phase
Phase not stated
Study type
Observational
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Enrolment target
500
Started
1 June 2023
Main results due
25 February 2032
Study sites
1
Registry updated
24 September 2026

Can you take part?

  • Ages 2 years to 120 years.
  • Open to any sex.
  • Healthy volunteers can take part.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
* 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(1)

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, United States

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT05738824. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Natural History of Inflammatory Muscle Diseases | Trialion