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A Continuation Study to Assess the Effect of CellCept in Patients With Myasthenia Gravis.

NCT ID: NCT00408213

Last Updated: 2008-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2007-09-30

Brief Summary

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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

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Conditions

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Myasthenia Gravis Generalised

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

mycophenolate mofetil [CellCept]

Intervention Type DRUG

1g po bid

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

po bid

Interventions

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mycophenolate mofetil [CellCept]

1g po bid

Intervention Type DRUG

Placebo

po bid

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aspreva Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Hoffmann-La Roche

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Sun City, Arizona, United States

Site Status

Sacramento, California, United States

Site Status

Upland, Pennsylvania, United States

Site Status

Bordeaux, , France

Site Status

Nice, , France

Site Status

München, , Germany

Site Status

Regensburg, , Germany

Site Status

Milan, , Italy

Site Status

Roma, , Italy

Site Status

Belgrade, , Serbia and Montenegro

Site Status

Kharkiv, , Ukraine

Site Status

Kiev, , Ukraine

Site Status

Zaporizhzhya, , Ukraine

Site Status

Liverpool, , United Kingdom

Site Status

Oxford, , United Kingdom

Site Status

Salford, , United Kingdom

Site Status

Countries

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Canada Czechia Israel Mexico Netherlands Spain United States France Germany Italy Serbia and Montenegro Ukraine United Kingdom

Other Identifiers

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WX18411

Identifier Type: -

Identifier Source: org_study_id

NCT00231088

Identifier Type: -

Identifier Source: nct_alias