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Sponsors and Collaborators: |
Washington University School of Medicine Amgen |
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Information provided by: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00802815 |
Inclusion body myositis (IBM) is the most common late onset acquired muscle disease. Patients develop progressive weakness that may result in the need for assistive devices including a wheelchair. IBM may be due to abnormal immune activation, due in part to overproduction of tumor necrosis factor (TNF)-alpha. Etanercept blocks the activity of TNF-alpha, thereby blunting immune overactivation. Previous unblinded studies and case reports suggest that etanercept may improve strength or slow the progressive weakness in IBM. We are conducting a double-blind, randomized, placebo-controlled study to test if Etanercept is beneficial in slowing the progressive weakness in patients with IBM.
Condition | Intervention | Phase |
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Inclusion Body Myositis |
Drug: Etanercept |
Phase 0 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Double-Blind, Randomized, Placebo-Controlled Trial of Etanercept for 12 Months in Subjects With Inclusion Body Myositis |
Estimated Enrollment: | 30 |
Study Start Date: | April 2005 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Etanercept: Experimental |
Drug: Etanercept
50 milligrams subcutaneously every week
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Glenn Lopate, MD | 314-362-6981 | lopateg@neuro.wustl.edu |
United States, Missouri | |
Washington University Department of Neurology | Recruiting |
Saint Louis, Missouri, United States, 63110 | |
Contact: Renee Renna, RN 314-362-6981 rennar@neuro.wustl.edu | |
Principal Investigator: Glenn Lopate, MD |
Principal Investigator: | Glenn Lopate, MD | Washington University School of Medicine |
Responsible Party: | Washington University ( Glenn Lopate ) |
Study ID Numbers: | 20031148 |
Study First Received: | December 4, 2008 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00802815 |
Health Authority: | United States: Institutional Review Board |
Myositis Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases |
Myositis, inclusion body Idiopathic myopathy Myositis, Inclusion Body TNFR-Fc fusion protein |
Anti-Inflammatory Agents Immunologic Factors Nervous System Diseases Physiological Effects of Drugs Gastrointestinal Agents Immunosuppressive Agents Pharmacologic Actions Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |