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Study and Treatment of Inflammatory Muscle Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00001265
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) )

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
Dermatomyositis 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) (1). Patients evaluated with IIM will receive 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 (2). MRI/PET will be performed on some patients and on healthy volunteers to evaluate its role in understanding muscle disease.

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Study Type : Observational
Estimated Enrollment : 999999 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Studies on the Natural History and Pathogenesis of Polymyositis, Dermatomyositis, and Related Diseases
Actual Study Start Date : January 10, 1992


Group/Cohort
Healthy Volunteers
Patients with no disease
Patients with muscle disease
Patients with known or suspected Idiopathic Inflammatory myopathies (IIM)



Primary Outcome Measures :
  1. Muscle strength [ Time Frame: End of Study ]
    To determine its utility in differentiating different muscle diseases, in identifying early extra muscular involvement of muscle diseases, in characterizing the pattern of muscle involvement for the diseases studied, and whether it can serve as a diagnostic tool to better identify muscle inflammation and atrophy.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Sampling Method:   Non-Probability Sample
Study Population
Healthy Volunteers and patients with known or suspected Idiopathic Inflammatory myopathies (IIM)
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.

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
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Contact: Nancy A Spencer (301) 827-0186 nancy.spencer@nih.gov
Contact: Andrew L Mammen, M.D. (301) 594-6667 andrew.mammen@nih.gov

Locations
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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
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Principal Investigator: Andrew L Mammen, M.D. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Additional Information:
Publications:
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Responsible Party: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier: NCT00001265    
Other Study ID Numbers: 910196
91-AR-0196
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 16, 2020
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
Dermatomyositis
Inclusion Body Myositis
Pathogenesis
Connective Tissue Diseases
Additional relevant MeSH terms:
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Dermatomyositis
Polymyositis
Myositis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
Skin Diseases