Understanding Inflammatory Muscle Diseases
Natural History of Inflammatory Muscle Diseases
This study is trying to learn more about inflammatory muscle diseases by collecting information and samples from people aged 12 and older to help improve how we diagnose and treat these conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 12 Years to 120 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT05738824 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect information and biospecimens from individuals with suspected or confirmed inflammatory muscle diseases, such as polymyositis and dermatomyositis. Participants aged 12 and older will undergo physical exams, blood tests, and MRI scans, with some having the option for muscle biopsies. The study seeks to characterize the different types of inflammatory myopathies, their causes, progression, and responses to treatments. By gathering this data, researchers hope to improve diagnostic methods and treatment strategies for these conditions.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 12 years and older with suspected or confirmed inflammatory muscle diseases, as well as healthy volunteers aged 18 and older.
Not a fit: Patients who are unwilling to participate in research studies or provide samples or data may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of inflammatory muscle diseases, ultimately improving patient outcomes.
How similar studies have performed: Other studies have shown success in characterizing inflammatory muscle diseases, but this specific observational approach may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1\. Ability of subject, or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent and/or assent document. 2a. Patients are adults and minors of age 12 or older, with possible inflammatory myopathy (suspected or confirmed) OR 2b. Healthy volunteers will be adults aged 18 or older. EXCLUSION CRITERIA: 1\. Unwilling to participate in research studies or to provide research samples or data.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Andrew L Mammen, M.D. — National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study coordinator: Julie G Thompson, R.N.
- Email: julie.thompson@nih.gov
- Phone: (301) 480-3191
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.