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Protocol Details

Studies on the Natural History and Pathogenesis of Polymyositis, Dermatomyositis, and Related Diseases

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

91-AR-0196

Sponsoring Institute

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

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 16
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

Autoimmune Diseases;
Idiopathic Inflammatory Myopathies;
Polymyositis;
Dermatomyositis;
Inclusion Body Myositis;
Pathogenesis

Recruitment Keyword(s)

Connective Tissue Diseases

Condition(s)

Autoimmune Disease;
Dermatomyositis;
Inclusion Body Myositis;
Myositis;
Polymyositis

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Arthritis and Musculoskeletal and Skin Diseases

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.

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Eligibility

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.


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Citations:

Polymyositis and dermatomyositis

Current concepts in the idiopathic inflammatory myopathies: polymyositis, dermatomyositis, and related disorders

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Contacts:

Principal Investigator

Referral Contact

For more information:

Andrew L. Mammen, M.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
BG 50 RM 1146
50 SOUTH DR
BETHESDA MD 20814
(301) 594-6667
andrew.mammen@nih.gov

Eileen D. Lange, R.N.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institutes of Health
Building 10
Room 6N226
10 Center Drive
Bethesda, Maryland 20892
(301) 435-8434
langeeil@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT00001265

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