Clinical trial Recruiting at 2 sites Observational Ages 2 to 100

Evaluating causes and effects of myositis in adults and children

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

Run by National Institutes of Health Clinical Center (CC) · NCT00017914 · Data updated 2026-11-12

This study looks at the causes and effects of myositis in both adults and children to better understand how it affects the immune system and overall health.

More Dermatomyositis trials

Quick facts

Study typeObservational
Ages2 Years to 100 Years
SexAll
Enrollment1200 (estimated)
SponsorNational Institutes of Health Clinical Center (CC)
NIH
Drugs / interventionsradiation
Locations4 sites (Atlanta, Georgia and 3 other locations)
StatusRecruiting
StartedJune 7, 1995
Registry record updatedSeptember 24, 2026
Trial IDNCT00017914 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include children and adults aged 2-100 with documented idiopathic inflammatory myopathy or related conditions.

Probably not a fit

Patients without any form of myositis or related inflammatory muscle diseases may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on individuals with adult- and childhood-onset myositis, including conditions like dermatomyositis and polymyositis. Participants will undergo comprehensive evaluations, including medical history, physical examinations, and various diagnostic tests such as muscle strength assessments and imaging studies. Healthy individuals will also be included as controls to provide comparative data. The goal is to better understand the immune system changes and medical issues associated with myositis.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of myositis, potentially enhancing patient outcomes.

How similar studies have gone: Other studies have explored myositis and its effects, indicating a foundation of knowledge, but this specific observational approach may provide novel insights.

Who can join: the full rules

Show full inclusion / exclusion criteria
* ELIGIBILITY CRITERIA:

Patients with Myositis:

Inclusion Criteria:

All patients should have age range 2-100 years.

All Patients admitted to the study must satisfy at least one of the following criteria among item 1 (A or B or C) OR item 2 (A or B or C) AND item 3:

1. Patient has documented evidence that he/she meets criteria for an idiopathic inflammatory myopathy

   A. Possible, probable or definite adult or juvenile polymyositis or dermatomyositis by Bohan and Peter criteria

   B. Possible, probable or definite inclusion body myositis by Griggs and/or ENMC criteria

   C. Has an idiopathic inflammatory myopathy that does not meet these criteria, including common or rarer forms of myositis such as cancer- associated, focal, orbital, eosinophilic myositis, macrophagic, proliferative, etc.
2. Has one of the following conditions:

2A. Have a disorder that is related to an idiopathic inflammatory myopathy, that may include:

* Inflammatory and non-inflammatory myopathies:
* Mimicking and related skin disorders:
* Disorders of the complications of myositis (including interstitial lung disease, calcifying disorders, cardiomyopathies, etc.):
* Overlapping autoimmune diseases that may be associated with myositis
* Patients with muscle and/or skin inflammation and documented environmental exposures:
* Patients with myositis or complications of myositis and suspected genetic disorders:
* Patients with undifferentiated connective tissue disease
* Patients with signs or symptoms of myositis (such as weakness, skin rashes, interstitial lung disease) or laboratory abnormalities (such as elevated CK or muscle biopsy with myopathic features) who do not have an established diagnosis of myositis for them to be evaluated to establish a diagnosis

  3\. Ability of patient or parent/guardian to give informed consent to all or part of the study after full information has been provided.

Exclusion Criteria:

1. Patients \<2 years or \>100 years will be excluded.
2. Any conditions in which the drawing of the amount of blood required or undergoing procedures needed for the study is not deemed medically appropriate by the treating physician or the principal investigator.

For females of childbearing potential who are pregnant, they will be permitted to enroll, but would be excluded from radiographic procedures involving radiation or greater than minimal risk procedures, including obtaining biopsies.

Relatives of Patients with Myositis:

For patients with at least one first-degree relative affected with IIIM, all available first-degree relatives (affected and unaffected) are eligible to participate in the genetics portion of the protocol. For patients in which two or more first degree relatives are affected with myositis, any available close relatives (affected or unaffected parents, siblings or children, as well as grandparents and grandchildren, or other close relatives, when available) are eligible to participate in the genetics portion of the protocol.

Inclusion criteria:

1. First or more distant relative of a proband with myositis, for genetics studies.
2. Ability of patient or parent/guardian to give informed consent to all or part of the study after full information has been provided.

Exclusion Criteria:

1. Patients \<2 years or \>100 years will be excluded.
2. Any conditions in which the drawing of the amount of blood required or undergoing procedures needed for the study is not deemed medically appropriate by the treating physician or the principal investigator.
3. Pregnancy (females of childbearing potential). Verbal confirmation they are not pregnant.

Healthy Volunteers:

Inclusion Criteria:

1. Healthy volunteer subjects for biomarker studies will be gender and age-matched (within 5 years) with a myositis patient, as reasonably close as possible.
2. Volunteer is not related to a myositis patient who is enrolled in the study
3. Volunteer is in good health, without a recognized systemic rheumatic disorder, autoimmune disease, immune medicated disease, or cancer, and is not taking any anti-inflammatory medicines, including nonsteroidal anti-inflammatory drugs (NSAIDS) or corticosteroids
4. Volunteer or volunteer s parent/guardian could give assent/informed consent to all or part of the study after full information has been provided

Exclusion Criteria:

If Any "Yes" answer patient is not eligible for study

1. Volunteer has undergone surgery or had a major trauma within the past 2 months
2. Volunteer used anti-inflammatory medications within the past 8 weeks of enrollment, including not currently receiving nonsteroidal anti-inflammatory drugs or corticosteroids
3. Volunteer has been diagnosed with a chronic infectious illness, inflammatory disease, malignancy, cardiac or pulmonary disease, muscle disorder, clotting disorder, metabolic disorder, systemic rheumatic or autoimmune disease, or immune-mediated disease
4. Volunteer is pregnant (verbally screened for females of childbearing potential)
5. Volunteer has a medical illness that in the judgement of the investigators does not allow safe blood draws or other clinical evaluations needed for study participation
6. Volunteer is cognitively impaired
7. Volunteer and or the volunteer's parents/legal guardian is unable or unwilling to give informed consent/assent
8. Volunteer has functional limitations
9. Volunteer has joint or muscle problems

In IMAGE Survey participants must confirm in the survey that they have a medical diagnosis of myositis.

Note that the following screening activities may be performed to determine subject eligibility:

* Email, written, or telephone communications with prospective subjects
* Review of existing medical records
* Review of existing imaging studies
* Review of existing photographs or videos
* Review of existing pathology specimens/reports from a specimen obtained for diagnostic purposes

If a participant is ineligible and willing, their contact information- including name, phone numbers, emails, best times to reach, and potential diagnosis- may be shared with other NIH investigators if the participant may be eligible to participate in those studies.

Where it's running

  • National Institutes of Health Clinical Center
    Bethesda, Maryland, United States
    Recruiting
  • NIEHS Clinical Research Unit (CRU)
    Research Triangle Park, North Carolina, United States
    Recruiting
  • Emory University
    Atlanta, Georgia, United States
    Completed
  • Texas Scottish Rite Hospital
    Dallas, Texas, United States
    Completed

Study contacts

  • Principal investigator: Lisa G Rider, M.D. — National Institute of Environmental Health Sciences (NIEHS)
  • Study coordinator: Lisa G Rider, M.D.
  • Email: riderl@mail.nih.gov
  • Phone: (301) 451-6272

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Patient-rooted insights to shape myositis science

    This global project asks people living with myositis (and their care partners) to share experiences and rank research questions so the community can see which issues matter most.

    Recruiting Myositis International Health & Research Collaborative Alliance Foundation · New Orleans, Louisiana · NCT07374107

  • Understanding how dazukibart works in patients with inflammatory muscle diseases

    This study is testing how well the medication dazukibart works for people with inflammatory muscle diseases like dermatomyositis and polymyositis to see if it helps reduce muscle inflammation and improve strength.

    Recruiting at 24 sites Phase 3 Pfizer · Glendale, Arizona and 25 other locations · NCT06698796

  • Using CAR T-cell therapy to treat severe autoimmune diseases

    This study is testing if a new CAR T-cell therapy can help people with severe autoimmune diseases like lupus and scleroderma feel better.

    Recruiting Phase 1/2 Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Rome, Lazio · NCT06685042

  • Using CAR-T cells to treat autoimmune diseases

    This study is testing a new treatment using modified T cells to see if it can help people with autoimmune diseases by targeting and removing harmful B cells.

    Recruiting Phase 1/2 Miltenyi Biomedicine GmbH · Erlangen, Bavaria · NCT06347718

  • Registry and biorepository for rheumatic diseases

    This study is collecting samples and health information from adults with rheumatic diseases at Yale clinics to help researchers learn more about these conditions and improve future treatments.

    Recruiting Yale University · New Haven, Connecticut · NCT04402086

  • Investigating environmental factors linked to anti-synthetase syndrome

    This study is trying to see if certain environmental factors, like infections or other triggers, might play a role in causing anti-synthetase syndrome in people with myositis.

    Recruiting at 2 sites National Institutes of Health Clinical Center (CC) · Miami, Florida and 7 other locations · NCT01276470

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.