A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Controlling Symptoms of Myasthenia Gravis

Phase 3

Completed

• Conditions: Myasthenia Gravis, Generalized
• Interventions: Drug: mycophenolate mofetil (CellCept); Drug: placebo

• Registration Number: NCT00683969
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2004-08
• Study Completion: 2007-05
• Status Verified: 2008-05
• Study First Submitted: 2008-05-19
• Study First Submitted QC: 2008-05-23
• Last Update Submitted: 2008-05-23
• Study First Posted: 2008-05-26
• Last Update Posted: 2008-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	mycophenolate mofetil (CellCept)	-
2	placebo	-

Primary Outcome Measures

Name	Time	Method
Proportion of subjects reaching responder status	Week 36

Secondary Outcome Measures

Name	Time	Method
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