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:

Patients with known or suspected idiopathic inflammatory myopathies (IIM) or patients with other connective tissue diseases with weakness or myalgias for an inflammatory myopathy or other muscle process.

EXCLUSION:

None other than inclusion criteria.

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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:
Christine J. Castro, D.O. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) National Institutes of Health BG 10 RM 6N216F MSC 1102 10 CENTER DR BETHESDA MD 20892-1102 (301) 443-5518 castroc2@mail.nih.gov	Mildred Wilson, R.N. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) National Institutes of Health Building 10 Room 6N216 10 Center Drive Bethesda, Maryland 20892 (301) 402-4884 wilson1@mail.nih.gov	Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT00001265

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