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

May 22, 2008 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

136

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Former Serbia and Montenegro
      • Belgrade, Former Serbia and Montenegro, 11000
  • France
      • Bordeaux, France
      • Nice, France
  • Germany
      • München, Germany, 81675
      • Regensburg, Germany, 93053
  • Italy
      • Milano, Italy, 20133
      • Roma, Italy, 185
  • Ukraine
      • Kharkov, Ukraine, 61068
      • Kiev, Ukraine
      • Zaporozhye, Ukraine
  • United Kingdom
      • Liverpool, United Kingdom, L9 1AE
      • Oxford, United Kingdom, OX2 6HE
      • Salford, United Kingdom, M6 8HD
  • United States
    • Arizona
      • Sun City, Arizona, United States, 85351
    • California
      • Sacramento, California, United States, 95817
    • Pennsylvania
      • Upland, Pennsylvania, United States, 19013

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Drug: Placebo
po bid
EXPERIMENTAL: 1
Drug: mycophenolate mofetil [CellCept]
1g po bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AEs, laboratory parameters, vital signs.
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Collaborators

Aspreva Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Study Completion (ACTUAL)

September 1, 2007

Study Registration Dates

First Submitted

December 5, 2006

First Submitted That Met QC Criteria

December 5, 2006

First Posted (ESTIMATE)

December 6, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 23, 2008

Last Update Submitted That Met QC Criteria

May 22, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WX18411

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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