Study and Treatment of Inflammatory Muscle Diseases

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001265
First received: November 3, 1999
Last updated: April 3, 2014
Last verified: March 2014
  Purpose

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
Autoimmune Disease
Dermatomyositis
Inclusion Body Myositis
Myositis
Polymyositis

Study Type: Observational
Official Title: Studies on the Natural History and Pathogenesis of Polymyositis, Dermatomyositis, and Related Diseases

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 99999999
Study Start Date: August 1991
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • 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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001265

Contacts
Contact: Mildred Wilson, R.N. (301) 402-4884 wilson1@mail.nih.gov
Contact: James D Katz, M.D. (301) 451-6807 james.katz@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 Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: James D Katz, M.D. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00001265     History of Changes
Other Study ID Numbers: 910196, 91-AR-0196
Study First Received: November 3, 1999
Last Updated: April 3, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
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

ClinicalTrials.gov processed this record on September 30, 2014