Status:
COMPLETED
A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Controlling Symptoms of Myasthenia Gravis
Lead Sponsor:
Hoffmann-La Roche
Collaborating Sponsors:
Aspreva Pharmaceuticals
Conditions:
Myasthenia Gravis, Generalized
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 underg...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2007
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT00683969
Start Date
August 1 2004
End Date
May 1 2007
Last Update
May 26 2008
Active Locations (43)
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1
Sun City, Arizona, United States
2
Sacramento, California, United States, 95817
3
Miami, Florida, United States, 33136
4
Kansas City, Kansas, United States, 66160-7314