NCT05738824 Natural History of Inflammatory Muscle Diseases
| NCT ID | NCT05738824 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
| Condition | Inflammation In Skeletal Muscle |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2023-06-01 |
| Primary Completion | 2032-02-25 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2023-06-01 with a primary completion date of 2032-02-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Objective: To collect information and biospecimens (such as blood, muscle, and skin samples) that will be used to research causes and treatments of inflammatory muscle diseases. Eligibility: People aged 2 years and older with suspected or confirmed inflammatory muscle disease. Healthy volunteers aged 18 years and older are also needed. Design: Participants will have at least 1 clinic visit. Each visit will last 4 to 8 hours. Some may return for additional visits. All participants will undergo these procedures (unless they are unable to): * Physical exam, including blood and urine tests. * 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. Some procedures are optional: * 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. * Skin biopsy: An area of skin will be numbed. A piece of skin about a quarter inch in diameter will be removed. * Lymph node biopsy: A small sample of fluid or tissue from a lymph node will taken to check for infection. * Genetic testing. Some of the samples collected may be used for genetic testing.
Eligibility 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 2 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.
Contact & Investigator
Andrew L Mammen, M.D.
PRINCIPAL INVESTIGATOR
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Frequently Asked Questions
Who can join the NCT05738824 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 120 Years, studying Inflammation In Skeletal Muscle. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05738824 currently recruiting?
Yes, NCT05738824 is actively recruiting participants. Contact the research team at julie.thompson@nih.gov for enrollment information.
Where is the NCT05738824 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT05738824 clinical trial?
NCT05738824 is sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The principal investigator is Andrew L Mammen, M.D. at National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The trial plans to enroll 500 participants.