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Double-Blind, Randomized, Placebo-Controlled Trial of Etanercept for 12 Months in Subjects With Inclusion Body Myositis
This study is currently recruiting participants.
Verified by Washington University School of Medicine, December 2008
Sponsors and Collaborators: Washington University School of Medicine
Amgen
Information provided by: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00802815
  Purpose

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
Inclusion Body Myositis
Drug: Etanercept
Phase 0

MedlinePlus related topics: Myositis
Drug Information available for: Etanercept
U.S. FDA Resources
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

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Change in Quantitative Muscle Testing on 12 proximal and 12 distal muscles [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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
Etanercept: Experimental Drug: Etanercept
50 milligrams subcutaneously every week

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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. Patients with a history of treated squamous cell carcinoma or basal cell carcinoma limited to the skin are not excluded.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00802815

Contacts
Contact: Glenn Lopate, MD 314-362-6981 lopateg@neuro.wustl.edu

Locations
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            
Sponsors and Collaborators
Washington University School of Medicine
Amgen
Investigators
Principal Investigator: Glenn Lopate, MD Washington University School of Medicine
  More Information

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

Study placed in the following topic categories:
Myositis
Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Myositis, inclusion body
Idiopathic myopathy
Myositis, Inclusion Body
TNFR-Fc fusion protein

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009