Is NCT00017914 recruiting in Research Triangle Park, NC?

Yes, NCT00017914 is currently recruiting participants at its Research Triangle Park, NC location. This dermatomyositis clinical trial is actively enrolling qualified participants.

How do I join the dermatomyositis clinical trial in Research Triangle Park?

To join this clinical trial in Research Triangle Park, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Research Triangle Park clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Dermatomyositis Clinical Trial in Research Triangle Park, NC

About This Dermatomyositis Study in Research Triangle Park

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.

Sponsor: National Institute of Environmental Health Sciences (NIEHS)

Who Can Participate

Inclusion Criteria

All patients should have age range 2-100 years. 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:

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.

Has one of the following conditions: 2A. Have a disorder that is related to an idiopathic inflammatory myopathy, that may include:

Inflammatory and non-inflammatory myopathies:

Mimicking and related skin disorders:

Disorders of the complications of myositis (including interstitial lung disease, calcifying disorders, cardiomyopathies, etc.):

Overlapping autoimmune diseases that may be associated with myositis

Patients with muscle and/or skin inflammation and documented environmental exposures:

Patients with myositis or complications of myositis and suspected genetic disorders:

Patients with undifferentiated connective tissue disease

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 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

Patients \<2 years or \>100 years will be excluded.

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. For females of childbearing potential who are pregnant, they will be permitted to enroll, but would be excluded from radiographic procedures involving radiation or greater than minimal risk procedures, including obtaining biopsies. Relatives of Patients with Myositis: 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. For patients in which two or more first degree relatives are affected with myositis, any available close relatives (affected or unaffected parents, siblings or children, as well as grandparents and grandchildren, or other close relatives, when available) are eligible to participate in the genetics portion of the protocol. Inclusion criteria:

First or more distant relative of a proband with myositis, for genetics studies.

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:

Patients \<2 years or \>100 years will be excluded.

Pregnancy (females of childbearing potential). Verbal confirmation they are not pregnant. Healthy Volunteers: Inclusion Criteria:

Healthy volunteer subjects for biomarker studies will be gender and age-matched (within 5 years) with a myositis patient, as reasonably close as possible.

Volunteer is not related to a myositis patient who is enrolled in the study

Volunteer is in good health, without a recognized systemic rheumatic disorder, autoimmune disease, immune medicated disease, or cancer, and is not taking any anti-inflammatory medicines, including nonsteroidal anti-inflammatory drugs (NSAIDS) or corticosteroids

Volunteer or volunteer s parent/guardian could give assent/informed consent to all or part of the study after full information has been provided Exclusion Criteria: If Any "Yes" answer patient is not eligible for study

Volunteer has undergone surgery or had a major trauma within the past 2 months

Volunteer used anti-inflammatory medications within the past 8 weeks of enrollment, including not currently receiving nonsteroidal anti-inflammatory drugs or corticosteroids

Volunteer has been diagnosed with a chronic infectious illness, inflammatory disease, malignancy, cardiac or pulmonary disease, muscle disorder, clotting disorder, metabolic disorder, systemic rheumatic or autoimmune disease, or immune-mediated disease

Volunteer is pregnant (verbally screened for females of childbearing potential)

Volunteer has a medical illness that in the judgement of the investigators does not allow safe blood draws or other clinical evaluations needed for study participation

Volunteer is cognitively impaired

Volunteer and or the volunteer's parents/legal guardian is unable or unwilling to give informed consent/assent

Volunteer has functional limitations

Volunteer has joint or muscle problems In IMAGE Survey participants must confirm in the survey that they have a medical diagnosis of myositis. Note that the following screening activities may be performed to determine subject eligibility:

Email, written, or telephone communications with prospective subjects

Review of existing medical records

Review of existing imaging studies

Review of existing photographs or videos

Review of existing pathology specimens/reports from a specimen obtained for diagnostic purposes If a participant is ineligible and willing, their contact information- including name, phone numbers, emails, best times to reach, and potential diagnosis- may be shared with other NIH investigators if the participant may be eligible to participate in those studies.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Research Triangle Park?

Yes, this clinical trial (NCT00017914) has an active research site in Research Triangle Park, NC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Dermatomyositis Treatment Options in Research Triangle Park, NC

If you're searching for dermatomyositis treatment options in Research Triangle Park, NC, this clinical trial (NCT00017914) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Research Triangle Park research site is actively enrolling participants for this clinical trial. You'll receive care from experienced dermatomyositis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all dermatomyositis clinical trials near you to find additional studies recruiting in your area.

Dermatomyositis Clinical Trial in Research Triangle Park, NC

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