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Study and Treatment of Inflammatory Muscle Diseases

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ClinicalTrials.gov Identifier: NCT00001265
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : October 8, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) )

Study Description
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Brief Summary:

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.


Condition or disease
Autoimmune Disease Dermatomyositis Inclusion Body Myositis Myositis Polymyositis

Detailed Description:
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.

Study Design
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Study Type : Observational
Estimated Enrollment : 99999999 participants
Official Title: Studies on the Natural History and Pathogenesis of Polymyositis, Dermatomyositis, and Related Diseases
Study Start Date : August 8, 1991

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Myositis

Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001265


Contacts
Contact: Eileen D Lange, R.N. (301) 435-8434 langeeil@mail.nih.gov
Contact: Andrew L Mammen, M.D. (301) 594-6667 andrew.mammen@nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Andrew L Mammen, M.D. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
More Information
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Additional Information:
NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier: NCT00001265     History of Changes
Other Study ID Numbers: 910196
91-AR-0196
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: September 25, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ):
Autoimmune Diseases
Idiopathic Inflammatory Myopathies
Polymyositis
Dermatomyositis
 Inclusion Body Myositis
Pathogenesis
Connective Tissue Diseases

Additional relevant MeSH terms:
Autoimmune Diseases
Dermatomyositis
Myositis
Polymyositis
Myositis, Inclusion Body
Immune System Diseases
 Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
Skin Diseases