Back to resultsA Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Controlling Symptoms of Myasthenia Gravis
Primary Purpose
Myasthenia Gravis, Generalized
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
mycophenolate mofetil (CellCept)
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Myasthenia Gravis, Generalized
Eligibility Criteria
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.
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Proportion of subjects reaching responder status
Secondary Outcome Measures
Time to start of response
Mean and median prednisone dose and cholinesterase inhibitor dose
Adverse events, lab parameters, vital signs
Full Information
NCT ID
NCT00683969
First Posted
May 19, 2008
Last Updated
May 23, 2008
Sponsor
Hoffmann-La Roche
Collaborators
Aspreva Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00683969
Brief Title
A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Controlling Symptoms of Myasthenia Gravis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hoffmann-La Roche
Collaborators
Aspreva Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myasthenia Gravis, Generalized
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
136 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
mycophenolate mofetil (CellCept)
Intervention Description
1g bid for 36 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
po bid for 36 weeks
Primary Outcome Measure Information:
Title
Proportion of subjects reaching responder status
Time Frame
Week 36
Secondary Outcome Measure Information:
Title
Time to start of response
Time Frame
Event driven
Title
Mean and median prednisone dose and cholinesterase inhibitor dose
Time Frame
Week 36
Title
Adverse events, lab parameters, vital signs
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche, 973-235-5000
Official's Role
Study Director
Facility Information:
City
Sun City
State/Province
Arizona
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7314
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14607
Country
United States
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7025
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013-3395
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
City
Belgrade
ZIP/Postal Code
11000
Country
Former Serbia and Montenegro
City
Bordeaux Cedex
Country
France
City
Nice
Country
France
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
City
München
ZIP/Postal Code
81675
Country
Germany
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
City
Hyderabad
Country
India
City
Mumbai
Country
India
City
New Delhi
Country
India
City
Jerusalem
ZIP/Postal Code
12000
Country
Israel
City
Milano
ZIP/Postal Code
20133
Country
Italy
City
Roma
ZIP/Postal Code
185
Country
Italy
City
San Donato Milanese
ZIP/Postal Code
20097
Country
Italy
City
Mexico City
ZIP/Postal Code
06700
Country
Mexico
City
Mexico City
ZIP/Postal Code
06726
Country
Mexico
City
Mexico City
ZIP/Postal Code
14000
Country
Mexico
City
Leiden
ZIP/Postal Code
2300 RC
Country
Netherlands
City
Maastricht
ZIP/Postal Code
6202 AZ
Country
Netherlands
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
City
Kazan
Country
Russian Federation
City
Moscow
Country
Russian Federation
City
Nizhniy Novgorad
Country
Russian Federation
City
Barcelona
Country
Spain
City
Madrid
Country
Spain
City
Kharkov
ZIP/Postal Code
61068
Country
Ukraine
City
Kiev
Country
Ukraine
City
Zaporozhye
ZIP/Postal Code
69035
Country
Ukraine
City
Liverpool
ZIP/Postal Code
L9 1AE
Country
United Kingdom
City
Oxford
ZIP/Postal Code
OX2 6HE
Country
United Kingdom
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
25032816
Citation
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.
Results Reference
derived
Learn more about this trial
A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Controlling Symptoms of Myasthenia Gravis
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