Who may be eligible for the Adult and Juvenile Myositis trial?

* 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 \ 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 \ 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.

ClinicalTrials.gov record NCT00017914

Adult and Juvenile Myositis

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 28, 2026

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

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

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 to 100 years old

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.

This observational study examines people and children with dermatomyositis, polymyositis, or inclusion body myositis, and healthy controls. It collects medical history, questionnaires, blood and urine tests, and may include more detailed 1- to 5-day evaluations. Some participants may return once for follow-up within a year. Optional procedures listed include imaging, muscle or skin biopsy, swallowing and voice testing, lung and heart tests, and muscle testing.

What it is studying. The study is observing people with the listed myositis types and healthy controls to learn about possible causes, immune-system changes, and medical problems linked to these conditions.

What the researchers hope to learn. Establish a secure outcomes data repository; compare clinical and immunopathogenic features of childhood- and adult-onset idiopathic inflammatory myopathies; investigate immunopathogenesis and immunogenetics of these diseases.

What this study is about

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

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:

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
Skin assessment, possibly including photographs of lesions and a skin biopsy (removal of a small skin sample under local anesthetic)
Magnetic resonance imaging (scans that use magnetic fields to visualize tissues) of leg muscles
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
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
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
Electrocardiogram (measurement of the electrical activity of the heart) and, possibly, echocardiogram (ultrasound imaging of the heart)
Endocrine evaluation
Eye examination, in patients with vision loss or other eye symptoms
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.
Muscle ultrasound.
Electromyography (record of the electrical activity of muscles)
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.

Eligibility

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

Inclusion criteria

ELIGIBILITY CRITERIA:
Patients with Myositis:
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:
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.
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
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

Patients <2 years or >100 years will be excluded.
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.
First or more distant relative of a proband with myositis, for genetics studies.
Ability of patient or parent/guardian to give informed consent to all or part of the study after full information has been provided.
Patients <2 years or >100 years will be excluded.
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.
Pregnancy (females of childbearing potential). Verbal confirmation they are not pregnant.
Healthy Volunteers:
Healthy volunteer subjects for biomarker studies will be gender and age-matched (within 5 years) with a myositis patient, as reasonably close as possible.
Volunteer is not related to a myositis patient who is enrolled in the study
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
Volunteer or volunteer s parent/guardian could give assent/informed consent to all or part of the study after full information has been provided
If Any "Yes" answer patient is not eligible for study
Volunteer has undergone surgery or had a major trauma within the past 2 months
Volunteer used anti-inflammatory medications within the past 8 weeks of enrollment, including not currently receiving nonsteroidal anti-inflammatory drugs or corticosteroids
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
Volunteer is pregnant (verbally screened for females of childbearing potential)
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
Volunteer is cognitively impaired
Volunteer and or the volunteer's parents/legal guardian is unable or unwilling to give informed consent/assent
Volunteer has functional limitations
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.

Study description and what participation involves

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

Show the detailed description from the registry

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
Skin assessment, possibly including photographs of lesions and a skin biopsy (removal of a small skin sample under local anesthetic)
Magnetic resonance imaging (scans that use magnetic fields to visualize tissues) of leg muscles
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
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
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
Electrocardiogram (measurement of the electrical activity of the heart) and, possibly, echocardiogram (ultrasound imaging of the heart)
Endocrine evaluation
Eye examination, in patients with vision loss or other eye symptoms
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.
Muscle ultrasound.
Electromyography (record of the electrical activity of muscles)
Muscle or skin biopsy (removal of a small piece of muscle tissue for microscopic examination)

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.

All participants will have a medical history and physical exam, complete questionnaires, give blood and urine samples, and allow review of their medical records. Some people may choose an additional 1- to 5-day evaluation (and all may return once within one year) that can include standardized muscle strength and gait testing, MRI of leg muscles, pulmonary function tests, heart tests (ECG and possibly echocardiogram), and nutrition assessments such as tape measurements or bioelectric impedance. Procedures that may be more invasive or uncomfortable include skin biopsy, muscle biopsy, electromyography (EMG), laryngoscopy (a small rigid scope to view the voice box), and swallowing studies that could include a modified barium swallow. Healthy volunteers and children will have similar but usually briefer testing; children ages 8–18 may also have exercise testing.

How the study is structured. This is an observational cohort study. All participants have medical history, questionnaires, a physical exam, and blood and urine tests. Participants may choose a shorter one-day evaluation or a longer 3- to 5-day evaluation that can include standardized muscle testing, imaging of muscles, swallowing and speech studies, pulmonary and cardiac tests, muscle or skin biopsy, electromyography, and nutritional or endocrine assessments. Participants may have a single visit or return once for a follow-up visit within one year.

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 7, 1995
Target enrollment: 1200 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 Environmental Health Sciences (NIEHS)

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.

Lisa G Rider, M.D. 📞 (301) 451-6272 ✉ riderl@mail.nih.gov

Participating sites (4)

Emory UniversityCompleted
Atlanta, Georgia, 30322 · United States
National Institutes of Health Clinical CenterRecruiting
Bethesda, Maryland, 20892 · United States
NIEHS Clinical Research Unit (CRU)Recruiting
Research Triangle Park, North Carolina, 27709 · United States
Texas Scottish Rite HospitalCompleted
Dallas, Texas, 75219 · United States

Terms used on this page · explanations by MedicalUpdates.ai

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.
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.
Electrocardiogram: A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
echocardiogram: An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
follow-up: The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
ELIGIBILITY CRITERIA: The rules the study team uses to decide who may take part. They are usually split into inclusion criteria and exclusion criteria.
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.
principal investigator: The doctor or scientist responsible for running the study at a site or overall.
childbearing potential: Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
biomarker: Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
corticosteroids: Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
assent: A child's or dependent adult's agreement to take part, given alongside the formal consent of a parent or legal representative.
enrollment: The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
legal guardian: A person who is legally allowed to make decisions, including consent to research, on behalf of someone who cannot consent for themselves.
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.

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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