- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00802815
Double-blind, Randomized, Placebo-controlled Trial of Etanercept for 12 Months in Subjects With Inclusion Body Myositis
May 28, 2014 updated by: Glenn Lopate, Washington University School of Medicine
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.
Study Overview
Detailed Description
Travel expenses not covered by the study.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University Department of Neurology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Etanercept
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50 milligrams subcutaneously every week
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Quantitative Muscle Testing on 12 proximal and 12 distal muscles
Time Frame: 12 months
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Glenn Lopate, MD, Washington University School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
December 4, 2008
First Submitted That Met QC Criteria
December 4, 2008
First Posted (Estimate)
December 5, 2008
Study Record Updates
Last Update Posted (Estimate)
May 29, 2014
Last Update Submitted That Met QC Criteria
May 28, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Myositis
- Myositis, Inclusion Body
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gastrointestinal Agents
- Etanercept
Other Study ID Numbers
- 20031148
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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