Actively Recruiting

Age: 2Years - 100Years
All Genders
Healthy Volunteers
ID00017914

Studies in the Natural History and Pathogenesis of Childhood-Onset and Adult-Onset Idiopathic Inflammatory Myopathies

Led by National Institute of Environmental Health Sciences (NIEHS) · Updated on 2026-06-03

1200

Participants Needed

4

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying both adult- and childhood-onset myositis, an inflammatory muscle disease that can damage muscles and other organs causing disability. This observational study aims to understand the causes, immune system changes, and medical problems linked to myositis by evaluating patients with polymyositis, dermatomyositis, inclusion body myositis, or related conditions. Healthy children and adults will also participate as control subjects for comparison. Participants will undergo a full medical history review, physical exams, and blood and urine tests. Some patients may opt for an extended 1- to 5-day evaluation including muscle strength tests, joint movement analysis, skin assessments, MRI scans of leg muscles, swallowing and voice studies, lung and heart function tests, endocrine and eye exams, nutrition assessments, muscle ultrasounds, electromyography, and biopsies of muscle or skin tissue. Healthy children will have similar evaluations but without invasive procedures and may also undergo exercise testing if aged 8 to 18 years. Participants can have a single evaluation or return for one follow-up visit within a year. Assessments include questionnaires, physical exams, imaging, and laboratory tests to track muscle and organ health. The main measurement is a Physician Global Assessment at enrollment and study visits. The study involves monitoring medical history, muscle function, organ involvement, and immune system changes over time to better understand myositis and related disorders.

CONDITIONS

Brief Title

Adult and Juvenile Myositis

Who Can Participate

Age: 2Years - 100Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 2 and 100 years
  • Diagnosis of idiopathic inflammatory myopathy including polymyositis, dermatomyositis, or inclusion body myositis
  • Related conditions such as inflammatory or non-inflammatory myopathies, overlapping autoimmune diseases, or muscle/skin inflammation with environmental or genetic factors
  • Ability of patient or parent/guardian to provide informed consent
  • Healthy volunteers matched by age and gender without autoimmune disease or anti-inflammatory medication use, not related to a myositis patient
  • Relatives of patients with myositis may participate in genetics studies with consent
Not Eligible

You will not qualify if you...

  • Age below 2 years or above 100 years
  • Conditions making blood draws or study procedures medically unsafe
  • Pregnant females excluded from radiation or higher risk procedures
  • Volunteers with recent surgery or major trauma within 2 months
  • Use of anti-inflammatory medications within 8 weeks before enrollment
  • Diagnosis of chronic infectious illness, inflammatory disease, cancer, cardiac or pulmonary disease, muscle disorder, clotting disorder, metabolic or autoimmune diseases
  • Pregnancy in volunteers
  • Cognitive impairment or inability to consent
  • Functional limitations or joint/muscle problems in volunteers
  • Relatives excluded if pregnant or medically unsuitable for study procedures
  • Any "Yes" answer to exclusion questions disqualifies healthy volunteers from participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 to 5 days

Participants undergo a one-time detailed evaluation including medical history, physical examination, questionnaires, blood and urine tests, and a variety of diagnostic procedures depending on their condition. These may include muscle strength testing, skin assessments, imaging studies, swallowing and speech assessments, pulmonary and cardiac function tests, endocrine and eye examinations, nutrition assessments, and biopsies.

1 to 5 visits depending on evaluation extent

Long-term Monitoring

Duration - Up to 1 year

Participants may return for one follow-up evaluation over a 1-year period to repeat some diagnostic assessments to monitor their condition.

1 follow-up visit within 1 year

Trial Site Locations

Total: 4 locations

1

Emory University

Atlanta, Georgia, United States, 30322

Completed

2

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

3

NIEHS Clinical Research Unit (CRU)

Research Triangle Park, North Carolina, United States, 27709

Actively Recruiting

4

Texas Scottish Rite Hospital

Dallas, Texas, United States, 75219

Completed

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Research Team

L

Lisa G Rider, M.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Published Research Related To This Trial

Genome-wide association study identifies HLA 8.1 ancestral haplotype alleles as major genetic risk factors for myositis phenotypes.

F W Miller, W Chen, T P O'Hanlon...

https://pubmed.ncbi.nlm.nih.gov/26291516

Neutrophil and mononuclear leukocyte pathways and upstream regulators revealed by serum proteomics of adult and juvenile dermatomyositis.

A Clare Sparling, James M Ward, Kakali Sarkar...

https://pubmed.ncbi.nlm.nih.gov/39529136

Quantification of autoantibodies using a luminescent profiling method in autoimmune interstitial lung disease.

Peter D Burbelo, Julio A Huapaya, Zohreh Khavandgar...

https://pubmed.ncbi.nlm.nih.gov/39524452

Myositis-Associated Autoantibodies in Patients With Juvenile Myositis Are Associated With Refractory Disease and Mortality.

Matthew A Sherman, Payam Noroozi Farhadi, Katherine Pak...

https://pubmed.ncbi.nlm.nih.gov/38272842