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| Name | Class |
|---|---|
| Aspreva Pharmaceuticals | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mycophenolate mofetil [CellCept] | Drug | 1g po bid |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| AEs, laboratory parameters, vital signs. | Throughout study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun City | Arizona | 85351 | United States | |||
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| Drug |
po bid |
|
| Sacramento |
| California |
| 95817 |
| United States |
| Upland | Pennsylvania | 19013 | United States |
| Bordeaux | France |
| Nice | France |
| München | 81675 | Germany |
| Regensburg | 93053 | Germany |
| Milan | 20133 | Italy |
| Roma | 185 | Italy |
| Belgrade | 11000 | Serbia and Montenegro |
| Kharkiv | 61068 | Ukraine |
| Kiev | Ukraine |
| Zaporizhzhya | Ukraine |
| Liverpool | L9 1AE | United Kingdom |
| Oxford | OX2 6HE | United Kingdom |
| Salford | M6 8HD | United Kingdom |
| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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