Safety and Efficacy Study of Eculizumab in Patients With Refractory Generalized Myasthenia Gravis

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Myasthenia Gravis

In brief

The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of patients with generalized myasthenia gravis despite treatment with various immunosuppressants, such as prednisone, methotrexate, Cellcept, cyclosporine, and cyclophosphamide, that are currently available.

Key facts

Study ID

NCT00727194

Run by

Alexion Pharmaceuticals, Inc.

People needed

14

Starts

2008-10-01

Expected to finish

2011-07-01

Last updated by the study team

2019-09-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Generalized MG
• 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.

You may not qualify if…

• History of thymoma or other neoplasms of the thymus.
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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