Back to resultsA Continuation Study to Assess the Effect of CellCept in Patients With Myasthenia Gravis.
Primary Purpose
Myasthenia Gravis Generalised
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 Generalised
Eligibility Criteria
Inclusion Criteria:
- subjects who have completed 36 weeks of treatment in study WX17798, and who have demonstrated good symptom control with a stable prednisone dose for the final 4 weeks of that study.
Exclusion Criteria:
- regularly scheduled plasma exchange or intravenous immunoglobulin treatment;
- medical condition, adverse event or intolerance of double-blind treatment which would preclude continuation.
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
AEs, laboratory parameters, vital signs.
Secondary Outcome Measures
Full Information
NCT ID
NCT00408213
First Posted
December 5, 2006
Last Updated
May 22, 2008
Sponsor
Hoffmann-La Roche
Collaborators
Aspreva Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00408213
Brief Title
A Continuation Study to Assess the Effect of CellCept in Patients With Myasthenia Gravis.
Official Title
A Randomized, Double-Blind Study to Evaluate the Safety of Continued Treatment With CellCept in Patients With Well-Controlled Myasthenia Gravis Receiving a Stable Dose of Prednisone
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hoffmann-La Roche
Collaborators
Aspreva Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
This 2 arm study will provide optional continuation of double-blind treatment with CellCept or placebo, in patients with myasthenia gravis who have achieved good symptom control in study WX17798. Patients who have completed 36 weeks of treatment in study WX17798, with stable prednisone dosing for the last 4 weeks, can continue on blinded treatment with CellCept (1g bid) or placebo until the database for WX17798 is locked and unblinded. 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 Generalised
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 po bid
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
po bid
Primary Outcome Measure Information:
Title
AEs, laboratory 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:
subjects who have completed 36 weeks of treatment in study WX17798, and who have demonstrated good symptom control with a stable prednisone dose for the final 4 weeks of that study.
Exclusion Criteria:
regularly scheduled plasma exchange or intravenous immunoglobulin treatment;
medical condition, adverse event or intolerance of double-blind treatment which would preclude continuation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
City
Belgrade
ZIP/Postal Code
11000
Country
Former Serbia and Montenegro
City
Bordeaux
Country
France
City
Nice
Country
France
City
München
ZIP/Postal Code
81675
Country
Germany
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
City
Milano
ZIP/Postal Code
20133
Country
Italy
City
Roma
ZIP/Postal Code
185
Country
Italy
City
Kharkov
ZIP/Postal Code
61068
Country
Ukraine
City
Kiev
Country
Ukraine
City
Zaporozhye
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
Learn more about this trial
A Continuation Study to Assess the Effect of CellCept in Patients With Myasthenia Gravis.
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