An observational study in Inflammation In Skeletal Muscle, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Recruiting at 1 site in United States. Open to participants aged 2 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Observational
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):
Some procedures are optional:
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.
73 studies on the registry are indexed under Polymyositis; 19 are open to participants now.
This study's planned enrollment of 500 is above the median of 152 across 22 observational studies indexed under Polymyositis.
Browse Polymyositis studies →National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is the lead sponsor of 100 studies on the registry; 12 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with possible inflammatory muscle disease (suspected or confirmed), and healthy volunteers.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
18 years old and up
greater than 2 years old
Define the different types of inflammatory muscle diseases, their etiology, pathogenesis, prognostic factors, and response to different treatments.
Severity of muscle, skin, pulmonary, and joint involvement. Study of the immune dysregulation, transcriptomic changes, and genetic modifications in patients with inflammatory muscle diseases.
Time frame: End of each visit
Study different diagnostic modalities that may help to diagnose and monitor the evolution of the disease in patients with myositis.
Utility of standard of care laboratory, radiologic, electrophysiologic, and clinical studies to diagnose and monitor the evolution of the disease in patients with myositis.
Time frame: at baseline
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) →