An observational study in Autoimmune/Connective Tissue Diseases, Idiopathic Inflammatory Myopathies and Polymyositis, sponsored by National Institute of Environmental Health Sciences (NIEHS). Completed at 1 site in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by National Institute of Environmental Health Sciences (NIEHS) · Observational
This study will define the major genetic risk and protective factors for idiopathic inflammatory myopathies (IIM), a group of immune disorders affecting connective tissues such as muscles. It will also identify new environmental risk factors for IIM and identify immune responses in myositis and related diseases. There are many forms of IIMs, and the causes of these diseases are unknown. However, scientists suspect that they result when people with some genetic factors that predispose them-that is, put them at greater risk-are exposed to certain environmental triggers. Some of those triggers include food, drugs, biologics (such as a vaccine to prevent disease), medical devices and occupational exposures.
Patients, including children under 18, who had a diagnosis of myositis, a related autoimmune disease, or a rheumatic disease, as well as their blood relatives, and control subjects who were in good health have already been recruited for this study.
The evaluation consisted of one outpatient visit to the patient's doctor, who will obtain a medical history and conduct a physician examination. Patients spent 20 to 30 minutes to answer written questions. There was a blood collection of about 6 tablespoons. If there was a major change in patients' medical conditions, they were asked to return for a second outpatient evaluation to determine whether any of the blood tests or antibodies, which show an immune response, had changed. Blood samples collected will be used only for laboratory research studies. The samples have been identified by a code, and all other identifying information have been removed.
During the study, researchers will explore possible environmental risk factors, including studies of infectious and non-infectious agents. They will analyze the blood for genetic markers and test for certain antibodies. Laboratory results will be evaluated as they relate to the signs, symptoms, and severity of patients' illnesses. That would help researchers to better understand patterns of the diseases and the outcomes for patients.
This study will not have a direct benefit for patients. However, results from the study can be made available to patients' doctors for use in appropriate care. Also, it is hoped that information gained can help other people in the future.
Individuals who develop chronic harmful inflammation in association with self-reactive autoantibodies or T cells are said to have autoimmune diseases. The causes of these diseases are unknown but they are thought to occur in genetically susceptible individuals after exposure to selected environmental agents. There are many forms of these diseases, but we have been focusing on one of the rarest and most poorly-studied group of autoimmune disorders, known as the Idiopathic Inflammatory Myopathies (IIM). This heterogeneous group of diseases includes polymyositis, dermatomyositis and related disorders. This is a natural history protocol designed to continue our study of these diseases and begin the evaluation of related connective tissue disorders associated with environmental exposures. We plan to further delineate important groups of patients and familial cases, and obtain useful material for further investigations of the clinical presentations, etiology, pathogenesis, and immunologic abnormalities of autoimmune/connective tissue diseases. Clinical data and patient blood, urine and tissue specimens have been collected by referring physicians and sent to us. The blood samples have been separated into cells and plasma, frozen and then placed into cell and plasma banks. Often the diagnosis of an IIM can be confused with other illness (such as adult-onset dystrophies), and therefore, we have also included patients with other illnesses (who are referred with a preliminary diagnosis of an IIM or an unknown myopathy), including patients with other autoimmune diseases. In order to understand more fully the genetic risk factors for these diseases, family members of selected patients who have several blood relatives with autoimmune or connective tissue diseases will also be studied. In summary, this natural history protocol will attempt, through a series of hypothesis-testing and hypothesis-generating studies, to obtain new information regarding the clinical presentation, risk and protective factors, pathogeneses and prognostic features for myositis and related conditions.
184 studies on the registry are indexed under Dermatomyositis; 63 are open to participants now.
This study's enrollment of 719 is above the median of 179 across 45 observational studies indexed under Dermatomyositis.
Browse Dermatomyositis studies →National Institute of Environmental Health Sciences (NIEHS) is the lead sponsor of 183 studies on the registry; 18 are open to participants now.
Compared within Dermatomyositis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Connective Tissue Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
children (\< 18 years of age) or adults (18 or more years of age) require a diagnosis of myositis or a related autoimmune or rheumatic disorder (by Bohan and Peter, American College of Rheumatology, or other criteria. Family members need to be blood relatives of the proband with the diagnosis of an autoimmune disease. Selected patients with other myopathies or with undefined illnesses who may have weakness, myalgias, or an elevated CK may be evaluated to establish a diagnosis. Normal volunteers will be gender- and race-matched to a subset of autoimmune subjects as controls needed for specific studies. Normal volunteers should be in good health, without a recognized systemic rheumatic disorder or other autoimmune disease, and should not be taking anti-inflammatory medicines, including non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids.
INCLUSION CRITERIA:
For the primary and myositis study populations, children (less than 18 years of age) or adults (18 or more years of age) require a diagnosis of myositis or a related autoimmune or rheumatic disorder.
Family members need to be blood relatives of the proband with the diagnosis of an autoimmune disease.
Normal volunteers will be gender- and race-matched to a subset of autoimmune subjects as controls needed for specific studies.
Normal volunteers should be in good health, without a recognized systemic rheumatic disorder or other autoimmune disease, and should not be taking anti-inflammatory medicines, including nonsteroidal anti-inflammatory drugs (NSAIDs) or .
For all subjects: ability of the subject or parents/legal guardians to provide to all aspects of the study after full protocol information is provided.
Patients enrolling in the MYOVISION national myositis patient registry were diagnosed with adult or juvenile DM, PM, IBM, or another form of myositis; resided within the United States or Canada at the time of diagnosis, and provided informed consent and completed the study questionnaires, either on paper or online. In the case of children \<18 years of age, the parent or legal guardian provided informed consent and completed the study questionnaires.
EXCLUSION CRITERIA:
Exclusion criteria for all protocol subjects:
Exclusion criteria for normal volunteers:
Recognized systemic rheumatic disorder or other autoimmune disease, history of cancer or taking anti-inflammatory medicines, including nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids, severe trauma, infections or vaccinations within 8 weeks.
Exclusion criteria for patients in the MYOVISION national myositis patient registry were subjects with cognitive impairment and those unable to or unwilling to give informed consent,or failing to meet the inclusion criteria of the study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Family members need to be blood relatives of the proband with the diagnosis of an autoimmune disease
Adult and pediatric patients with diagnosis of myositis or a related autoimmune or rheumatic disorder (by Bohan and Peter criteria, American College of Rheumatology, or other criteria).
gender and race-matched to a subset of autoimmune subjects as controls. Should be without any autoimmune disease.
Myositis Autoantibodies
Individuals who develop autoimmune diseases are associated with self-reactive autoantibodies. The clinical course of disease in IIM appears to be more closely related to the presence of certain myositis-specific autoantibodies
Time frame: at the time of enrollment visit
Human leukocyte antigen
The efforts to identify candidate genes will initially include polymorphic MHC and non-MHC immune response genes such as those for HLA,cytokines and chemokines with the strongest known associations with autoimmunity
Time frame: at the time of enrollment visit
Environmental Exposures
Assessment of possible selected environmental risk factors will include studies of infectious and non-infectious agents by immunologic and other approaches. Birthdates, seasonal and geographic associations with disease onset, as well as unusual clustering in the frequencies of selected phenotypes or genotypes will also be studied.
Time frame: ongoing
Clinical Phenotyping of
The different phenotypes and immunologic abnormalities found in the clinicopathologic and immune response groups of the IIM suggest possible different pathogenesis and risk factors.
Time frame: ongoing
Pathogenesis of the Disease
to find possible different pathogenesis of multiple immune-mediated disorders.
Time frame: ongoing
Plan to share: Undecided — The study team is still deciding if they would like to share individual participant data
Started Jul 2005 (actual).
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Institute of Environmental Health Sciences (NIEHS) →