Studies on the Natural History and Pathogenesis of Polymyositis, Dermatomyositis, and Related Diseases
| City: |
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Bethesda |
| State: |
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Maryland |
| Zip Code: |
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20892 |
| Conditions: |
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Autoimmune Disease - Dermatomyositis - Inclusion Body Myositis - Myositis - Polymyositis |
| Purpose: |
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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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| Study Summary: |
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Polymyositis, dermatomyositis and related disorders, also known as the idiopathic
inflammatory myopathies (IIM), are an uncommon, heterogeneous group of diseases. This is an
omnibus protocol designed to continue our description of this rare group of diseases,
further delineate important groups of patients, and obtain useful material for further study
of immunological abnormalities, pathogenesis and etiology of IIM. Often the diagnosis of an
IIM can be confused with other illness (such as adult-onset dystrophies), and therefore, we
will be evaluating patients with other illnesses (who are referred with a preliminary
diagnosis of an IIM). Patients evaluated with IIM will receive with informed consent the
best standard therapies available and consideration for entry into any therapeutic
protocols. MRI will be performed on healthy volunteers to help develop a mathematical method
for quantitating edema of muscle MRI in patients. MRI/PET will be performed on some
patients and on healthy volunteers to evaluate its role in understanding muscle disease.
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| Criteria: |
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- 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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| NCT ID: |
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NCT00001265 |
| Primary Contact: |
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Principal Investigator
Christine J Castro, D.O.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Mildred Wilson, R.N.
Phone: (301) 402-4884
Email: wilson1@mail.nih.gov
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| Backup Contact: |
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Email: castroc2@mail.nih.gov
Christine J Castro, D.O.
Phone: (301) 443-5518
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| Location Contact: |
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Bethesda, Maryland 20892
United States
For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
Phone: 800-411-1222
Email: prpl@mail.cc.nih.gov
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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