Adult and Juvenile Myositis
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies, Skin and Soft Tissue Infections, Infectious Disease, Neurology, Nephrology |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Immunology / Infectious Diseases, Nephrology / Urology, Neurology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/6/2019 |
| Start Date: | June 8, 1994 |
| Contact: | Lisa G Rider, M.D. |
| Email: | riderl@mail.nih.gov |
| Phone: | (301) 451-6272 |
Studies in the Natural History and Pathogenesis of Childhood-Onset and Adult-Onset Idiopathic Inflammatory Myopathies
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.
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.
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.
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.
- INCLUSION CRITERIA:
All Patients admitted to the study must satisfy at least one of the following criteria
among item 1 (A or B or C) OR item 2 (A or B or C) AND item 3:
1. Patient has documented evidence that he/she meets criteria for an idiopathic
inflammatory myopathy
A. Possible, probable or definite adult or juvenile polymyositis or dermatomyositis by
Bohan and Peter criteria
B. Possible, probable or definite inclusion body myositis by Griggs and/or ENMC
criteria
C. Has an idiopathic inflammatory myopathy that does not meet these criteria,
including common or rarer forms of myositis such as cancer- associated, focal,
orbital, eosinophilic myositis, macrophagic, proliferative, etc.
2. Has one of the following conditions:
2A. Have a disorder that is related to an idiopathic inflammatory myopathy, that may
include:
i. Inflammatory and non-inflammatory myopathies:
ii. Mimicking and related skin disorders:
iii. Disorders of the complications of myositis (including interstitial lung disease,
calcifying disorders, cardiomyopathies, etc.):
iv. Overlapping autoimmune diseases that may be associated with myositis
v. Patients with muscle and/or skin inflammation and documented environmental exposures:
vi. Patients with myositis or complications of myositis and suspected genetic disorders:
vii. Patients with undifferentiated connective tissue disease
viii. Patients with signs or symptoms of myositis (such as weakness, skin rashes,
interstitial lung disease) or laboratory abnormalities (such as elevated CK or muscle
biopsy with myopathic features) who do not have an established diagnosis of myositis for
them to be evaluated to establish a diagnosis.
2B. For patients with at least one first-degree relative affected with IIIM, all available
first-degree relatives (affected and unaffected) are eligible to participate in the
genetics portion of the protocol.
2C. Healthy control subject needed for sub-studies in the protocol. (see Protocol Section
7, Healthy Control Subjects).
3. Ability of patient or parent/guardian to give informed consent to all or part of the
study after full information has been provided.
EXCLUSION CRITERIA:
Any conditions in which the drawing of 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..
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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