Study and Treatment of Inflammatory Muscle Diseases

Conditions Phase Intervention Type
N/A

Eligibility

Ages Eligible for Study
16 years and up
Genders Eligible for Study
Both

Keywords

Autoimmune Diseases, Idiopathic Inflammatory Myopathies, Polymyositis, Dermatomyositis, Inclusion Body Myositis, Pathogenesis, and Connective Tissue Diseases

Sponsors

NIH
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Inclusion Criteria

All eligible patients are invited to participate in this protocol. Patients are adults and
minors, aged 16 or higher, with possible idiopathic muscle disease (suspected or
confirmed). Since both men and women are affected with the disease, both sexes will be
studied. All ethnic and racial groups are at risk and will be included. Healthy volunteers
will be eligible only if they are adults aged 18 or older and only if they are willing to
provide informed consent.

EXCLUSION:

- Children (age less than 16 years) are excluded

- Subjects with severe active infection (such as requiring intravenous antibiotics) or
other co-morbidities that in the opinion of the investigator would warrant exclusion.

- Subjects or their legal guardians who are unable or unwilling to give informed
consent/assent.

Exclusion Criteria

Detailed Description

This study of inflammatory muscle diseases-polymyositis and dermatomyositis and related disorders-will examine what causes these diseases and describe the clinical features (signs and symptoms) associated with them. Inflammation and degeneration of skeletal muscles in these disorders leads to weakness and muscle wasting. The skin, lungs and other organs may also be involved. Patients 16 years of age and older with polymyositis, dermatomyositis, or a related disorder may be eligible for this study. Participants will undergo a complete history and physical examination, including routine blood and urine tests. Additional procedures for diagnosis, treatment or research may include: 1. Blood sample for genetic studies. 2. Muscle biopsy-removal of a tissue sample for microscopic examination. Under local anesthetic, a 1/2- to 1-inch long incision is made in the thigh or upper arm, and a small piece of muscle is removed. 3. Electromyography-measurement of the electrical activity of a muscle. A needle is inserted through the skin into a muscle to record its electrical activity. 4. Magnetic resonance imaging-visualization of organs or tissues, using a magnetic field and radio waves. The patient lies on a table inside a narrow cylinder (the MRI scanner) with a strong magnetic field for the scanning. 5. Manual muscle strength testing by a physiotherapist. 6. Swallowing studies using ultrasound (imaging using sound waves) and X-rays (barium swallow) to evaluate swallowing and speaking abilities. 7. Questionnaires on swallowing ability and ability to perform daily living activities 8. Pulmonary function tests-measurement of movement of air in and out of the lungs. The patient breathes into a machine to evaluate lung function. 9. Chest X-rays to evaluate lung function. 10. Electrocardiogram and, if necessary, Holter monitoring (measurement of the electrical activity of the heart) and echocardiogram (ultrasound imaging of the heart) to evaluate heart function. 11. Apheresis-collection of white blood cells for research. Whole blood is collected through a needle placed in an arm vein. The blood circulates through a machine that separates it into its components. The white cells are removed and the rest of the blood is returned to the body through the same needle or through a second one placed in the other arm. 12. MR guided muscle biopsy-measurement of glycogen in muscle tissue using magnetic resonance imaging. Certain patients may undergo this experimental procedure to compare MRI findings with those of muscle biopsy. The affected muscles are identified using MRI and the biopsy incision is made. MRI is then used to guide the biopsy needle to the muscle and a small piece is removed. Patients who are eligible for experimental treatment studies will be offered the opportunity to join them. Others will be advised of treatment recommendations.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001265

Overall Contact

Andrew L Mammen, M.D.
(301) 594-6667

Overall Contact Backup

Eileen D Lange, R.N.
(301) 435-8434

Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike
    Bethesda, Maryland United States

    Status: Recruiting

    Contact info For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
    800-411-1222xTTY8664111010