NCT00017914

Adult and Juvenile Myositis

Recruiting now Last updated 7 April 2026

What this trial tests

trial in Dermatomyositis in 1,200 participants. Currently enrolling.

Timeline

7 June 1995

Quick facts

Lead sponsor	National Institute of Environmental Health Sciences (NIEHS)
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	1,200
Start date	7 June 1995
Sites	4 locations across United States

Conditions studied

• Dermatomyositis — all drugs for Dermatomyositis →
• Polymyositis — all drugs for Polymyositis →
• Inclusion Body Myositis — all drugs for Inclusion Body Myositis →

Sponsor

National Institute of Environmental Health Sciences (NIEHS)

Who can join

Adults 2 to 100, any sex, with Dermatomyositis or Polymyositis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will evaluate subjects with adult- and childhood-onset myositis to learn more about their cause and the immune system changes and medical problems associated with them. Myositis is an inflammatory muscle disease that can damage muscles and other organs, resulting in significant disability.

Children or adults with polymyositis or dermatomyositis or a related condition may be evaluated under this study. Healthy children or adults will also be enrolled as "controls," for comparison of test results.

All patients will undergo a complete history (including completing some questionnaires) and physical examination, review of medical records, and blood and urine tests. Patients may then choose to participate in an additional 1- to 5-day evaluation, which will include some or all of the following diagnostic, treatment or research procedures:

1. Standardized muscle strength testing, range of motion of joints and walking (gait) analysis by a physiotherapist; completion of a questionnaire regarding ability to perform daily tasks
2. Skin assessment, possibly including photographs of lesions and a skin biopsy (removal of a small skin sample under local anesthetic)
3. Magnetic resonance imaging (scans that use magnetic fields to visualize tissues) of leg muscles
4. Swallowing studies, including a physical examination and questionnaire on swallowing ability, studies of tongue strength, and ultrasound imaging during swallowing, and possibly, a modified barium swallow
5. Voice and speech assessment, possibly including computerized voice analysis and laryngoscopy-analysis of the larynx (voice box) using a small rigid scope with a camera placed in the mouth to view and record vocal cord function
6. Pulmonary function tests (measurement of air moved into and out of the lungs, using a breathing machine) to evaluate lung function and, possibly, chest X-ray
7. Electrocardiogram (measurement of the electrical activity of the heart) and, possibly, echocardiogram (ultrasound imaging of the heart)
8. Endocrine evaluation
9. Eye examination, in patients with vision loss or other eye symptoms
10. Nutrition assessment to evaluate muscle mass and muscle wasting, including tape measurements or bioelectric impedance testing, a painless procedure in which wires are attached to the extremities with a sticky paste.
11. Muscle ultrasound.
12. Electromyography (record of the electrical activity of muscles)
13. Muscle or skin biopsy (removal of a small piece of muscle tissue for microscopic examination)

All patients may have only a one-time evaluation or may return for one follow-up evaluations (either the 1-day or 3- to 5-day evaluation) over a 1-year period.

Healthy children will undergo a medical history and brief physical examination; blood and urine tests; speech and swallowing studies including questionnaires and physical examination, tongue strength, and ultrasound study; and bioelectric impedance testing. Children 8 to 18 years old may also have exercise testing.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Phage display of environmental protein toxins and virulence factors reveals the prevalence, persistence, and genetics of antibody responses.
   Angkeow JW, Monaco DR, Chen A, Venkataraman T, et al · · 2022 · cited 34× · PMID 35649416 · DOI 10.1016/j.immuni.2022.05.002
2. Improvement in Disease Activity in Refractory Juvenile Dermatomyositis Following Abatacept Therapy.
   Curiel RV, Nguyen W, Mamyrova G, Jones D, et al · · 2023 · cited 14× · PMID 36657109 · DOI 10.1002/art.42450
3. Myositis-Associated Autoantibodies in Patients With Juvenile Myositis Are Associated With Refractory Disease and Mortality.
   Sherman MA, Noroozi Farhadi P, Pak K, Trieu EP, et al · · 2024 · cited 6× · PMID 38272842 · DOI 10.1002/art.42813
4. Clinical Features and Immunogenetic Risk Factors Associated With Additional Autoantibodies in Anti-Transcriptional Intermediary Factor 1γ Juvenile-Onset Dermatomyositis.
   Sherman MA, Yang Q, Gutierrez-Alamillo L, Pak K, et al · · 2024 · cited 6× · PMID 38059274 · DOI 10.1002/art.42768
5. Development of a computed tomography calcium scoring technique for assessing calcinosis distribution, pattern and burden in dermatomyositis.
   Cervantes BA, Gowda P, Rider LG, Miller FW, et al · · 2024 · cited 5× · PMID 37286372 · DOI 10.1093/rheumatology/kead256
6. Factors associated with interstitial lung disease among patients with idiopathic inflammatory myopathies.
   Wilkerson JC, Miller FW, Bridge MF, Larson GJ, et al · · 2026 · cited 1× · PMID 41317376 · DOI 10.1093/rheumatology/keaf625
7. Reliability of durometry to assess firmness of calcinosis lesions in Juvenile and adult dermatomyositis.
   Nelson MC, Rider LG, Kim H, Gillespie S, et al · · 2026 · PMID 41871052 · DOI 10.1371/journal.pone.0343708
8. PROMIS displays strong construct validity in pediatric and adult patients with idiopathic inflammatory myopathies.
   Austenfeld EM, Sabbagh SE, Liegl M, Yan K, et al · · 2026 · PMID 40996336 · DOI 10.1093/rheumatology/keaf502