Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Researchers launch major study to unravel mysteries of muscle disease

NCT ID NCT00017914

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 17, 2026 · Updated 13 times

Summary

This study aims to learn more about myositis, a group of diseases that cause muscle inflammation and damage. Researchers will observe up to 1,200 children and adults with myositis, along with healthy volunteers, to track changes in the immune system and other health problems over time. Participants undergo various tests like blood work, muscle strength assessments, and imaging, but no new treatments are being tested.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 1995

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

1- Any patient who has documented evidence that he/she meets criteria for an idiopathic inflammatory myopathy; 2- Any patient who has been diagnosed with inflammatory/non-inflammatory myopathies, mimicking and related skin disorders, disorders of complications of myositis, 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 or laboratory abnormalities who do not have an established diagnosis of myositis for them to be evaluated to establish a diagnosis; 3- Close relatives of patients with at least one first-degree relative affected with IIIM (affected or unaffected siblings, children, parents, grandparents) can participate in the genetics portion of the protocol; 4- Healthy control subjects.

Ages

2 to 100 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Dermatomyositis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Emory University

    COMPLETED

    Atlanta, Georgia, 30322, United States

  • NIEHS Clinical Research Unit (CRU)

    RECRUITING

    Research Triangle Park, North Carolina, 27709, United States

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

  • Texas Scottish Rite Hospital

    COMPLETED

    Dallas, Texas, 75219, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.