A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Controlling Symptoms of Myasthenia Gravis
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter, 36-Week Trial to Assess the Efficacy and Safety of Adjunct Mycophenolate Mofetil (MMF) to Maintain or Improve Symptom Control With Reduced Corticosteroid in Subjects With Myasthenia Gravis
1 other identifier
interventional
136
14 countries
43
Brief Summary
The efficacy and safety of CellCept (1g po, bid for 36 weeks) will be assessed in patients with myasthenia gravis receiving prednisone, or other corticosteroids. During the study, patients will undergo gradual corticosteroid dose reduction, if they respond to treatment. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2004
Typical duration for phase_3
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 19, 2008
CompletedFirst Posted
Study publicly available on registry
May 26, 2008
CompletedMay 26, 2008
May 1, 2008
May 19, 2008
May 23, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of subjects reaching responder status
Week 36
Secondary Outcomes (3)
Time to start of response
Event driven
Mean and median prednisone dose and cholinesterase inhibitor dose
Week 36
Adverse events, lab parameters, vital signs
Throughout study
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- adult patients 18 to 80 years of age;
- 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.
You may not qualify if:
- female patients who are pregnant, breastfeeding, or lactating;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoffmann-La Rochelead
- Aspreva Pharmaceuticalscollaborator
Study Sites (43)
Unknown Facility
Sun City, Arizona, United States
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Sacramento, California, 95817, United States
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Miami, Florida, 33136, United States
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Kansas City, Kansas, 66160-7314, United States
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Rochester, New York, 14607, United States
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Chapel Hill, North Carolina, 27599-7025, United States
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Columbus, Ohio, 43210, United States
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Upland, Pennsylvania, 19013-3395, United States
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Dallas, Texas, 75390, United States
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Galveston, Texas, 77555, United States
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Edmonton, Alberta, T6G 2B7, Canada
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London, Ontario, N6A 5A5, Canada
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Bordeaux, France
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Nice, France
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Düsseldorf, 40225, Germany
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München, 81675, Germany
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Regensburg, 93053, Germany
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Tübingen, 72076, Germany
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Hyderabad, India
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Mumbai, India
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New Delhi, India
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Jerusalem, 12000, Israel
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Milan, 20133, Italy
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Roma, 185, Italy
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San Donato Milanese, 20097, Italy
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Mexico City, 06700, Mexico
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Mexico City, 06726, Mexico
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Mexico City, 14000, Mexico
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Leiden, 2300 RC, Netherlands
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Maastricht, 6202 AZ, Netherlands
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Rotterdam, 3015 GD, Netherlands
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Kazan', Russia
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Moscow, Russia
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Nizhniy Novgorad, Russia
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Belgrade, 11000, Serbia and Montenegro
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Barcelona, Spain
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Madrid, Spain
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Kharkiv, 61068, Ukraine
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Kiev, Ukraine
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Zaporizhzhya, 69035, Ukraine
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Liverpool, L9 1AE, United Kingdom
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Oxford, OX2 6HE, United Kingdom
Unknown Facility
Salford, M6 8HD, United Kingdom
Related Publications (1)
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.
PMID: 25032816DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche, 973-235-5000
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 19, 2008
First Posted
May 26, 2008
Study Start
August 1, 2004
Study Completion
May 1, 2007
Last Updated
May 26, 2008
Record last verified: 2008-05