Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00408213
Status:
COMPLETED
Last Update Posted:
2008-05-23
First Post:
2006-12-05
Brief Title:
A Continuation Study to Assess the Effect of CellCept in Patients With Myasthenia Gravis
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None