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Sponsored by: |
National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00030212 |
This study will examine the abnormal immune response in patients with sporadic inclusion body myositis (s-IBM)-the most common inflammatory muscle disease in people over the age of 50. s-IBM progresses steadily and may lead to severe weakness and wasting of arm and leg muscles. Patients may become unable to perform daily living activities and be confined to wheelchairs. s-IBM is thought to be an autoimmune disease, in which the body's own immune system attacks healthy muscles. This study will explore the causes of the muscle tissue inflammation that is responsible for destruction of muscle fibers and weakness in this disease. Information from the study may help in the development of an effective treatment for this disease.
Patients with s-IBM may be eligible for this study. Those who are unable to travel or who have severe cardiovascular, renal or other end-stage organ disease will be excluded. Candidates will be screened for eligibility with a medical history and physical and neurological examinations.
Participants will be seen at the NIH Clinical Center every six months over a 12-month period (visits at enrollment, 6 months and 12 months) either on an inpatient or outpatient basis, depending on their disease severity. Each 2- to 3-day visit will involve the following tests and evaluations:
Condition |
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Sporadic Inclusion Body Myositis |
Study Type: | Observational |
Official Title: | Study of Immune Dysregulation in Patients With Sporadic Inclusion Body Myositis (s-IBM) |
Estimated Enrollment: | 80 |
Study Start Date: | February 2002 |
Estimated Study Completion Date: | December 2007 |
Sporadic Inclusion Body Myositis (s-IBM) is the most common acquired myopathy above the age of 50 years. It is a disabling disease that leads to wheelchair confinement. The cause is unknown but autoimmune mechanisms have been implicated. The primary goal of the study is to search for candidate autoantigen(s) that drive the autoimmune response and identify candidate pathogenic T-cell epitopes among the endomysial T-cells extracted from the patients' muscle biopsies. It is anticipated that the search for the antigens implicated in the clonal expansion of endomysial T-cells over time will elucidate the autoimmune pathogenesis of the disease and lead to the development of antigen-specific immunomodulatory therapeutic strategies. This is an investigative study intended to better define the pathogenesis of s-IBM. No new therapy will be provided except of standard care.
Ages Eligible for Study: | 25 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Enrolled patients should fulfill the clinical and laboratory criteria of s-IBM.
EXCLUSION CRITERIA:
Very advanced disease state that precludes traveling;
Severe cardiovascular, renal, or other end-organ-disease states.
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | |
Bethesda, Maryland, United States, 20892 | |
United States, Pennsylvania | |
Thomas Jefferson University | |
Philadelphia, Pennsylvania, United States, 19107-6541 |
Study ID Numbers: | 020121, 02-N-0121 |
Study First Received: | February 7, 2002 |
Last Updated: | March 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00030212 |
Health Authority: | United States: Federal Government |
T Cell IBM Inflammatory Myopathies Antigenic Epitopes |
Endomysial T Lymphocytes Myositis Inclusion Body Myositis Inflammatory Myopathy |
Myositis Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases |
Myositis, inclusion body Idiopathic myopathy Myositis, Inclusion Body Congenital Abnormalities |
Nervous System Diseases |