A Continuation Study to Assess the Effect of CellCept in Patients With Myasthenia Gravis.
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
1 other identifier
interventional
136
7 countries
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2004
Typical duration for phase_3
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 5, 2006
CompletedFirst Posted
Study publicly available on registry
December 6, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedMay 23, 2008
May 1, 2008
December 5, 2006
May 22, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
AEs, laboratory parameters, vital signs.
Throughout study
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- regularly scheduled plasma exchange or intravenous immunoglobulin treatment;
- medical condition, adverse event or intolerance of double-blind treatment which would preclude continuation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoffmann-La Rochelead
- Aspreva Pharmaceuticalscollaborator
Study Sites (16)
Unknown Facility
Sun City, Arizona, 85351, United States
Unknown Facility
Sacramento, California, 95817, United States
Unknown Facility
Upland, Pennsylvania, 19013, United States
Unknown Facility
Bordeaux, France
Unknown Facility
Nice, France
Unknown Facility
München, 81675, Germany
Unknown Facility
Regensburg, 93053, Germany
Unknown Facility
Milan, 20133, Italy
Unknown Facility
Roma, 185, Italy
Unknown Facility
Belgrade, 11000, Serbia and Montenegro
Unknown Facility
Kharkiv, 61068, Ukraine
Unknown Facility
Kiev, Ukraine
Unknown Facility
Zaporizhzhya, Ukraine
Unknown Facility
Liverpool, L9 1AE, United Kingdom
Unknown Facility
Oxford, OX2 6HE, United Kingdom
Unknown Facility
Salford, M6 8HD, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 5, 2006
First Posted
December 6, 2006
Study Start
June 1, 2004
Study Completion
September 1, 2007
Last Updated
May 23, 2008
Record last verified: 2008-05