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Double-blind, Randomized, Placebo-controlled Trial of Etanercept for 12 Months in Subjects With Inclusion Body Myositis

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ClinicalTrials.gov Identifier: NCT00802815
Recruitment Status : Completed
First Posted : December 5, 2008
Last Update Posted : May 29, 2014
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Glenn Lopate, Washington University

Brief Summary:
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 or disease Intervention/treatment Phase
Inclusion Body Myositis Drug: Etanercept Early Phase 1

Detailed Description:
Travel expenses not covered by the study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind, Randomized, Placebo-controlled Trial of Etanercept for 12 Months in Subjects With Inclusion Body Myositis
Study Start Date : April 2005
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014


Arm Intervention/treatment
Experimental: Etanercept Drug: Etanercept
50 milligrams subcutaneously every week
Other Name: Enbrel



Primary Outcome Measures :
  1. Change in Quantitative Muscle Testing on 12 proximal and 12 distal muscles [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A clinical diagnosis of definite or probable IBM.
  • Male or female aged 18-80.
  • Subjects must be able to provide informed consent.
  • Subjects must be on no immunosuppressive medication for 3 months and agree not to take immunosuppressive medication during the study.
  • Subjects must not be on sulfasalazine
  • Subjects or caregivers must be able to administer SQ medication.
  • Women of childbearing potential (not postmenopausal or surgically sterile) must have a negative pregnancy test at screening and be using adequate birth control.
  • Absence of exclusion criteria.

Exclusion Criteria:

  • Exposure to etanercept within 3 months of study entry
  • Exposure to other investigational drugs within 3 months of study entry.
  • Subject with known hypersensitivity to etanercept.
  • Subject with active medical or psychiatric condition that in the opinion of the principal investigator, may affect the interpretation of the safety and efficacy data or which otherwise contraindicates participation in the study.
  • Signs, symptoms or laboratory evidence of severe renal, pulmonary, hepatic, neurologic, or cardiac (congestive heart failure, or coronary artery) disease, including creatinine > 2.0, LFT > 2x the upper limit of normal and hemoglobin < 12.5 (male) and < 11.0 (female).
  • Subject with weakness from any other neurological or neuromuscular disease, including multiple sclerosis or other CNS demyelinating disease.
  • Subject with sepsis or any active, chronic, or local infection or on antibiotic, antiviral or antifungal medication within 3 months prior to the first dose of Etanercept.
  • A prior history of tuberculosis and/or a positive PPD skin test at screening (including reading of borderline, reactive but non-diagnostic) or prior inoculated subjects.
  • Human immunodeficiency virus infection.
  • Subject with history of opportunistic infection.
  • Subject with a known history of anti-Jo-1, anti-SRP or anti-MI-2 antibodies.
  • The presence of an associated connective tissue disease, including systemic lupus erythematous, Sjögren's syndrome, scleroderma or mixed connective tissue disease.
  • History of a new diagnosis or treatment of invasive malignancy within 5 years of enrollment, including patients with a history of squamous cell carcinoma or basal cell carcinoma.
  • History of drug or alcohol abuse within 1 year prior to study entry.
  • Unwillingness to practice effective contraception, except for female patients who are post-menopausal or surgically sterile. The rhythm method is not to be used as the sloe method of contraception.
  • Subjects are not to receive live vaccines while in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00802815


Locations
United States, Missouri
Washington University Department of Neurology
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Amgen
Investigators
Principal Investigator: Glenn Lopate, MD Washington University School of Medicine

Responsible Party: Glenn Lopate, Associate Professor of Neurology, Washington University
ClinicalTrials.gov Identifier: NCT00802815     History of Changes
Other Study ID Numbers: 20031148
First Posted: December 5, 2008    Key Record Dates
Last Update Posted: May 29, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Myositis
Myositis, Inclusion Body
Muscular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Etanercept
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors