A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Controlling Symptoms of Myasthenia Gravis
NCT ID: NCT00683969
Last Updated: 2008-05-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
136 participants
INTERVENTIONAL
2004-08-31
2007-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
mycophenolate mofetil (CellCept)
1g bid for 36 weeks
2
placebo
po bid for 36 weeks
Interventions
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mycophenolate mofetil (CellCept)
1g bid for 36 weeks
placebo
po bid for 36 weeks
Eligibility Criteria
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Inclusion Criteria
* diagnosis of myasthenia gravis;
* history of myasthenia weakness involving more than ocular (ie eye) or peri-ocular muscle;
* duration of myasthenia gravis symptoms (including ocular symptoms) \<=10 years;
* prednisone dose \>=20 mg/day (or equivalent alternate-day dose) for \>=4 weeks.
Exclusion Criteria
* regularly scheduled plasma exchange (PE) or intravenous immunoglobulin (IVIG) treatment, or PE or IVIG treatment within 2 weeks prior to randomization;
* any prior clinically significant use of CellCept or other immunosuppressive therapy (except corticosteroids), or within 8 weeks prior to randomization.
18 Years
80 Years
ALL
No
Sponsors
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Aspreva Pharmaceuticals
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Hoffmann-La Roche
Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche, 973-235-5000
Locations
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Sun City, Arizona, United States
Sacramento, California, United States
Miami, Florida, United States
Kansas City, Kansas, United States
Rochester, New York, United States
Chapel Hill, North Carolina, United States
Columbus, Ohio, United States
Upland, Pennsylvania, United States
Dallas, Texas, United States
Galveston, Texas, United States
Edmonton, Alberta, Canada
London, Ontario, Canada
Bordeaux, , France
Nice, , France
Düsseldorf, , Germany
München, , Germany
Regensburg, , Germany
Tübingen, , Germany
Hyderabad, , India
Mumbai, , India
New Delhi, , India
Jerusalem, , Israel
Milan, , Italy
Roma, , Italy
San Donato Milanese, , Italy
Mexico City, , Mexico
Mexico City, , Mexico
Mexico City, , Mexico
Leiden, , Netherlands
Maastricht, , Netherlands
Rotterdam, , Netherlands
Kazan', , Russia
Moscow, , Russia
Nizhniy Novgorad, , Russia
Belgrade, , Serbia and Montenegro
Barcelona, , Spain
Madrid, , Spain
Kharkiv, , Ukraine
Kiev, , Ukraine
Zaporizhzhya, , Ukraine
Liverpool, , United Kingdom
Oxford, , United Kingdom
Salford, , United Kingdom
Countries
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References
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Sengupta M, Cheema A, Kaminski HJ, Kusner LL; Muscle Study Group. Serum metabolomic response of myasthenia gravis patients to chronic prednisone treatment. PLoS One. 2014 Jul 17;9(7):e102635. doi: 10.1371/journal.pone.0102635. eCollection 2014.
Other Identifiers
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WX17798
Identifier Type: -
Identifier Source: org_study_id
NCT00090636
Identifier Type: -
Identifier Source: nct_alias