Clinical Trial Finder

Natural History of Inflammatory Muscle Diseases

Study Purpose

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 12 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.
  • - Genetic testing.
Some of the samples collected may be used for genetic testing.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 12 Years and Over
Gender All
More 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05738824
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Andrew L Mammen, M.D.
Principal Investigator Affiliation National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Inflammation In Skeletal Muscle
Study Website: View Trial Website
Additional Details

Study Description: This is an observational study to characterize the different types of inflammatory myopathies, understand their etiology, pathogenesis, prognosis, and response to different treatments. Objectives: Primary objective: Define the different types of inflammatory muscle diseases, their etiology, pathogenesis, prognostic factors, and response to different treatments. Secondary objectives: Study different diagnostic modalities that may help to diagnose and monitor the evolution of the disease in patients with myositis. Endpoints: Primary 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. Secondary 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.

Arms & Interventions

Arms

: Healthy Volunteers

18 years old and up

: Patients

greater than 12 years

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Bethesda, Maryland

Status

Recruiting

Address

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

Site Contact

NIH Clinical Center Office of Patient Recruitment (OPR)

[email protected]

800-411-1222 #TTY dial 711

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