ClinicalTrials.gov record NCT05738824

Natural History of Inflammatory Muscle Diseases

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Natural History of Inflammatory Muscle Diseases

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age2 years old and older
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

An observational study collecting medical information and biospecimens from people aged 2 years and older with suspected or confirmed inflammatory muscle disease, and healthy volunteers aged 18 and older. Visits include a clinic exam, blood and urine tests, and a thigh MRI; some procedures (muscle, skin, or lymph-node biopsy, genetic testing) are optional. Participants attend at least one visit (about 4–8 hours); some may return for additional visits.

What it is studying. The study is collecting data and samples to describe types of inflammatory muscle diseases, measure severity in muscle, skin, lung, and joints, and study immune, transcriptomic, and genetic changes; it will also assess diagnostic and monitoring tests.

What the researchers hope to learn. Define the different types of inflammatory muscle diseases and their etiology, pathogenesis, and prognostic factors. Study immune dysregulation, transcriptomic and genetic changes, and evaluate the utility of lab, imaging, electrophysiologic, and clinical studies for diagnosis and monitoring.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants have at least one clinic visit lasting about 4–8 hours; some people may return for additional visits. At visits they will have a physical exam, blood and urine tests, and a thigh MRI (about 40 minutes lying in the scanner with padding around one thigh). Optional procedures include muscle biopsy (area numbed; small cut and removal of several tiny pieces of muscle), skin biopsy (about a quarter‑inch piece removed after numbing), lymph‑node sampling, and genetic testing of collected samples. Samples and data will be collected for research; optional procedures may be declined.

How the study is structured. Prospective observational cohort. Participants provide medical history and undergo a physical exam, blood and urine tests, and a thigh MRI at a minimum visit lasting about 4–8 hours. Optional procedures include muscle, skin, or lymph-node biopsies and genetic testing. Some people may have additional follow-up visits.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on dermatomyositis

This trial is also listed on this site under polymyositis.

Clinical trials59 trials listed for dermatomyositisEvery trial the registry lists for dermatomyositis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in dermatomyositis researchLatest monthly update: September 2026. Includes: Upadacitinib case reports. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jun 1, 2023
Primary completion
Feb 25, 2032 (estimated)
Study completion
Feb 25, 2032 (estimated)
Target enrollment
500 participants (estimated)
Last updated on registry
Sep 24, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

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

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

biospecimens
A collection of biological samples, such as blood or tissue, stored with medical information so that researchers can study them later.
Magnetic resonance imaging
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
biopsy
Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
Legally Authorized Representative
A person who is legally allowed to make decisions, including consent to research, on behalf of someone who cannot consent for themselves.
written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
assent
A child's or dependent adult's agreement to take part, given alongside the formal consent of a parent or legal representative.
INCLUSION CRITERIA
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
EXCLUSION CRITERIA
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
Primary objective
The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
Endpoints
Something the study measures to judge its results, such as a symptom score, a blood test or survival. Outcomes are grouped as primary, secondary and sometimes exploratory.
standard of care
Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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