Status:
TERMINATED
Safety and Efficacy Study of Eculizumab in Patients With Refractory Generalized Myasthenia Gravis
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Myasthenia Gravis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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, su...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00727194
Start Date
October 1 2008
End Date
July 1 2011
Last Update
September 24 2019
Active Locations (25)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
University of California, Irvine
Orange, California, United States, 92868
3
University of California - Davis
Sacramento, California, United States, 95817
4
University of Florida & Shands Neuroscience Institute
Jacksonville, Florida, United States, 32209