Safety and Efficacy Study of Eculizumab in Patients With Refractory Generalized Myasthenia Gravis
NCT ID: NCT00727194
Last Updated: 2019-09-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
14 participants
INTERVENTIONAL
2008-10-31
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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1
eculizumab
eculizumab
eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses
2
Placebo
Placebo
Placebo IV weekly for 4 doses then every two weeks for 7 doses
Interventions
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eculizumab
eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses
Placebo
Placebo IV weekly for 4 doses then every two weeks for 7 doses
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* MGFA Clinical Classification Class II, III or IVa.
* QMG total score ≥12
* Minimum score of two (2) in four (4) or more test items in the QMG
* Able to give informed consent.
* Have failed at least two immunosuppressants after one year of treatment
* A positive serologic test for binding anti-acetylcholine receptor Abs at Screening and one of the following a) history of abnormal neuromuscular transmission test demonstrated by single-fiber electromyography or repetitive nerve stimulation, or b) history of positive anticholinesterase test, eg, edrophonium chloride test, or c) patient has demonstrated improvement in MG signs on acetylcholinesterase inhibitors as assessed by treating physician.
Exclusion Criteria
* History of thymectomy within 12 months prior to screening.
* Pregnancy or lactation
* Current or chronic use of plasmapheresis/plasma exchange
* IVIG treatment within 8 weeks prior to screening.
* Use of etanercept within 2 months prior to screening.
* Use of rituximab (RITUXAN®) within 6 months prior to screening.
* MGFA Class I, IVb, and V
* Crisis or impending crisis
18 Years
80 Years
ALL
No
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California, Irvine
Orange, California, United States
University of California - Davis
Sacramento, California, United States
University of Florida & Shands Neuroscience Institute
Jacksonville, Florida, United States
Emory University
Atlanta, Georgia, United States
Wishard Hospital
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Caritas St. Elizabeths' Medical Center
Boston, Massachusetts, United States
Wayne State University
Detroit, Michigan, United States
Mount Sinai School of Medicine
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
University Hospitals - Case Medical Center
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
The Warren Alpert Medical School of Brown University
Providence, Rhode Island, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Southwestern Medical School
Dallas, Texas, United States
The University of Vermont College of Medicine
Burlington, Vermont, United States
University of Virginia
Charlottesville, Virginia, United States
The Northern Alberta Clinical trials and Research Centre
Edmonton, Alberta, Canada
Institute of Neurological Sciences, Department of Neurology, Southern General Hospital,
Glasgow, , United Kingdom
Institute of Neurology
London, , United Kingdom
Department of Clinical Neurology, West Wing, John Radcliffe Hospital
Oxford, , United Kingdom
Countries
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References
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Howard JF Jr, Barohn RJ, Cutter GR, Freimer M, Juel VC, Mozaffar T, Mellion ML, Benatar MG, Farrugia ME, Wang JJ, Malhotra SS, Kissel JT; MG Study Group. A randomized, double-blind, placebo-controlled phase II study of eculizumab in patients with refractory generalized myasthenia gravis. Muscle Nerve. 2013 Jul;48(1):76-84. doi: 10.1002/mus.23839. Epub 2013 Apr 30.
Other Identifiers
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C08-001
Identifier Type: -
Identifier Source: org_study_id
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