[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100496024":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":22,"studyPopulation":23,"armGroups":24,"interventions":18,"overallOfficials":31,"centralContacts":36,"locations":45,"responsibleParty":66,"collaborators":18,"id":68,"slug":18,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":18,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":18,"studyType":80,"phases":18,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":48,"whyStopped":18,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"National Institutes of Health Clinical Center (CC)","NIH",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Define the different types of inflammatory muscle diseases, their etiology, pathogenesis, prognostic factors, and response to different treatments.","Severity of muscle, skin, pulmonary, and joint involvement. Study of the immune dysregulation, transcriptomic changes, and genetic modifications in patients with inflammatory muscle diseases.","End of each visit",[14],{"measure":15,"description":16,"timeFrame":17},"Study different diagnostic modalities that may help to diagnose and monitor the evolution of the disease in patients with myositis.","Utility of standard of care laboratory, radiologic, electrophysiologic, and clinical studies to diagnose and monitor the evolution of the disease in patients with myositis.","at baseline",null,{"allocation":18,"interventionModel":18,"interventionModelDescription":18,"primaryPurpose":18,"observationalModel":20,"timePerspective":21,"maskingInfo":18},"COHORT","PROSPECTIVE","Study Description:\n\nThis is an observational study to characterize the different types of inflammatory myopathies, understand their etiology, pathogenesis, prognosis, and response to different treatments.\n\nObjectives:\n\nPrimary objective: Define the different types of inflammatory muscle diseases, their etiology, pathogenesis, prognostic factors, and response to different treatments.\n\nSecondary objectives: Study different diagnostic modalities that may help to diagnose and monitor the evolution of the disease in patients with myositis.\n\nEndpoints:\n\nPrimary endpoint: Severity of muscle, skin, pulmonary, and joint involvement. Study of the immune dysregulation, transcriptomic changes, and genetic modifications in patients with inflammatory muscle diseases.\n\nSecondary endpoints: Utility of standard of care laboratory, radiologic, electrophysiologic, and clinical studies to diagnose and monitor the evolution of the disease in patients with myositis.","Patients with possible inflammatory muscle disease (suspected or confirmed), and healthy volunteers.",[25,28],{"label":26,"type":18,"description":27,"interventionNames":18},"Healthy Volunteers","18 years old and up",{"label":29,"type":18,"description":30,"interventionNames":18},"Patients","greater than 2 years old",[32],{"name":33,"affiliation":34,"role":35},"Andrew L Mammen, M.D.","National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":18,"email":41},"Julie G Thompson, R.N.","CONTACT","(301) 480-3191","julie.thompson@nih.gov",{"name":33,"role":39,"phone":43,"phoneExt":18,"email":44},"(301) 594-6667","andrew.mammen@nih.gov",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"National Institutes of Health Clinical Center","RECRUITING","Bethesda","Maryland","20892","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-77.10026,38.98067,{"lat":58,"lon":57},[61],{"name":62,"role":39,"phone":63,"phoneExt":64,"email":65},"NIH Clinical Center Office of Patient Recruitment (OPR)","800-411-1222","TTY dial 711","ccopr@nih.gov",{"type":67,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100496024",false,"NCT05738824","Natural History of Inflammatory Muscle Diseases","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1\\. Ability of subject, or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent and\u002For assent document.\n\n2a. Patients are adults and minors of age 2 or older, with possible inflammatory myopathy (suspected or confirmed)\n\nOR\n\n2b. Healthy volunteers will be adults aged 18 or older.\n\nEXCLUSION CRITERIA:\n\n1\\. Unwilling to participate in research studies or to provide research samples or data.",true,"ALL","2 Years","120 Years",{"count":78,"type":79},500,"ESTIMATED","OBSERVATIONAL","Objective:\n\nTo collect information and biospecimens (such as blood, muscle, and skin samples) that will be used to research causes and treatments of inflammatory muscle diseases.\n\nEligibility:\n\nPeople aged 2 years and older with suspected or confirmed inflammatory muscle disease. Healthy volunteers aged 18 years and older are also needed.\n\nDesign:\n\nParticipants will have at least 1 clinic visit. Each visit will last 4 to 8 hours. Some may return for additional visits.\n\nAll participants will undergo these procedures (unless they are unable to):\n\n* Physical exam, including blood and urine tests.\n* Magnetic resonance imaging (MRI) scan of the thigh. Participants will lie still on a table with padding around 1 thigh. The table will slide into a tube. The scan will last for approximately 40 minutes.\n\nSome procedures are optional:\n\n* Muscle biopsy: An area of skin will be numbed. A quarter-inch cut will be made. Several pieces of muscle tissue, about the size of grains of rice, will be removed.\n* Skin biopsy: An area of skin will be numbed. A piece of skin about a quarter inch in diameter will be removed.\n* Lymph node biopsy: A small sample of fluid or tissue from a lymph node will taken to check for infection.\n* Genetic testing. Some of the samples collected may be used for genetic testing.",[83],"Inflammation In Skeletal Muscle",[85,86,87,88],"Polymyositis","Dermatomyositis","Childhood Dermatomyositis","Natural History","2026-06-25",{"date":91,"type":92},"2026-06-26","ACTUAL",{"date":94,"type":92},"2023-06-01",{"date":96,"type":79},"2032-02-25",{"name":34,"class":6},1]