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Adult and Juvenile Myositis
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), April 2008
Sponsored by: National Institute of Environmental Health Sciences (NIEHS)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00017914
  Purpose

This study will evaluate subjects with adult- and childhood-onset myositis to learn more about their cause and the immune system changes and medical problems associated with them. Myositis is an inflammatory muscle disease that can damage muscles and other organs, resulting in significant disability.

Children or adults with polymyositis or dermatomyositis or a related condition may be evaluated under this study. Healthy children or adults will also be enrolled as "controls," for comparison of test results.

All patients will undergo a complete history (including completing some questionnaires) and physical examination, review of medical records, and blood and urine tests. Patients may then choose to participate in an additional 1- to 5-day evaluation, which will include some or all of the following diagnostic, treatment or research procedures:

  1. Standardized muscle strength testing, range of motion of joints and walking (gait) analysis by a physiotherapist; completion of a questionnaire regarding ability to perform daily tasks
  2. Skin assessment, possibly including photographs of lesions and a skin biopsy (removal of a small skin sample under local anesthetic)
  3. Magnetic resonance imaging (scans that use magnetic fields to visualize tissues) of leg muscles
  4. Swallowing studies, including a physical examination and questionnaire on swallowing ability, studies of tongue strength, and ultrasound imaging during swallowing, and possibly, a modified barium swallow
  5. Voice and speech assessment, possibly including computerized voice analysis and laryngoscopy-analysis of the larynx (voice box) using a small rigid scope with a camera placed in the mouth to view and record vocal cord function
  6. Pulmonary function tests (measurement of air moved into and out of the lungs, using a breathing machine) to evaluate lung function and, possibly, chest X-ray
  7. Electrocardiogram (measurement of the electrical activity of the heart) and, possibly, echocardiogram (ultrasound imaging of the heart)
  8. Endocrine evaluation
  9. Eye examination, in patients with vision loss or other eye symptoms
  10. Nutrition assessment to evaluate muscle mass and muscle wasting, including tape measurements or bioelectric impedance testing, a painless procedure in which wires are attached to the extremities with a sticky paste.
  11. Muscle ultrasound.
  12. Electromyography (record of the electrical activity of muscles)
  13. Muscle or skin biopsy (removal of a small piece of muscle tissue for microscopic examination)

All patients may have only a one-time evaluation or may return for one follow-up evaluations (either the 1-day or 3- to 5-day evaluation) over a 1-year period.

Healthy children will undergo a medical history and brief physical examination; blood and urine tests; speech and swallowing studies including questionnaires and physical examination, tongue strength, and ultrasound study; and bioelectric impedance testing. Children 8 to 18 years old may also have exercise testing.


Condition
Dermatomyositis
Polymyositis
Idiopathic Inflammatory Myopathy
Healthy

MedlinePlus related topics: Muscle Disorders Myositis Ultrasound
U.S. FDA Resources
Study Type: Observational
Official Title: Studies in the Natural History and Pathogenesis of Childhood-Onset and Adult-Onset Idiopathic Inflammatory Myopathies

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

Estimated Enrollment: 600
Study Start Date: June 1994
Detailed Description:

This study will evaluate subjects with adult- and childhood-onset myositis to learn more about their cause and the immune system changes and medical problems associated with them. Myositis is an inflammatory muscle disease that can damage muscles and other organs, resulting in significant disability.

Children or adults with polymyositis or dermatomyositis or a related condition may be evaluated under this study. Healthy children or adults will also be enrolled as "controls," for comparison of test results.

All patients will undergo a complete history (including completing some questionnaires) and physical examination, review of medical records, and blood and urine tests. Patients may then choose to participate in an additional 1- to 5-day evaluation, which will include some or all of the following diagnostic, treatment or research procedures:

  1. Standardized muscle strength testing, range of motion of joints and walking (gait) analysis by a physiotherapist; completion of a questionnaire regarding ability to perform daily tasks
  2. Skin assessment, possibly including photographs of lesions and a skin biopsy (removal of a small skin sample under local anesthetic)
  3. Magnetic resonance imaging (scans that use magnetic fields to visualize tissues) of leg muscles
  4. Swallowing studies, including a physical examination and questionnaire on swallowing ability, studies of tongue strength, and ultrasound imaging during swallowing, and possibly, a modified barium swallow
  5. Voice and speech assessment, possibly including computerized voice analysis and laryngoscopy-analysis of the larynx (voice box) using a small rigid scope with a camera placed in the mouth to view and record vocal cord function
  6. Pulmonary function tests (measurement of air moved into and out of the lungs, using a breathing machine) to evaluate lung function and, possibly, chest X-ray
  7. Electrocardiogram (measurement of the electrical activity of the heart) and, possibly, echocardiogram (ultrasound imaging of the heart)
  8. Endocrine evaluation
  9. Eye examination, in patients with vision loss or other eye symptoms
  10. Nutrition assessment to evaluate muscle mass and muscle wasting, including tape measurements or bioelectric impedance testing, a painless procedure in which wires are attached to the extremities with a sticky paste.
  11. Muscle ultrasound.
  12. Electromyography (record of the electrical activity of muscles)
  13. Muscle or skin biopsy (removal of a small piece of muscle tissue for microscopic examination)

All patients may have only a one-time evaluation or may return for one follow-up evaluations (either the 1-day or 3- to 5-day evaluation) over a 1-year period.

Healthy children will undergo a medical history and brief physical examination; blood and urine tests; speech and swallowing studies including questionnaires and physical examination, tongue strength, and ultrasound study; and bioelectric impedance testing. Children 8 to 18 years old may also have exercise testing.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

All patients admitted to the study must satisfy the following criteria:

  1. Meet probable or definite criteria for IIM by Bohan and Peter.
  2. Ability of Patient or parent/guardian to give informed consent to all or part of the study after full information has been provided.
  3. Selected patients with undefined illnesses who may have weakness, myalgias, or an elevated CK may be evaluated to establish a diagnosis and, if they are found to have IIM, would be offered the opportunity to enter the study.

EXCLUSION CRITERIA:

1. Severe medical diseases requiring intensive care or any other conditions in which drawing the amount of blood required or undergoing procedures needed for the study is not deemed medically appropriate by the treating physician or the principal investigator.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00017914

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: 940165, 94-E-0165
Study First Received: June 19, 2001
Last Updated: July 18, 2008
ClinicalTrials.gov Identifier: NCT00017914  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Juvenile Dermatomyositis
Juvenile Polymyositis
Autoimmune Diseases
Disease Activity Assessment
Myositis-Specific Autoantibodies
Dermatomyositis
Polymyositis
Idiopathic Inflammatory Myopathy

Study placed in the following topic categories:
Juvenile dermatomyositis
Autoimmune Diseases
Skin Diseases
Healthy
Myositis
Dermatomyositis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Autoantibodies
Polymyositis
Connective Tissue Diseases
Idiopathic myopathy

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009