A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Controlling Symptoms of Myasthenia Gravis

May 23, 2008 updated by: Hoffmann-La Roche

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter, 36-Week Trial to Assess the Efficacy and Safety of Adjunct Mycophenolate Mofetil (MMF) to Maintain or Improve Symptom Control With Reduced Corticosteroid in Subjects With Myasthenia Gravis

The efficacy and safety of CellCept (1g po, bid for 36 weeks) will be assessed in patients with myasthenia gravis receiving prednisone, or other corticosteroids. During the study, patients will undergo gradual corticosteroid dose reduction, if they respond to treatment. 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

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
    • Ontario
      • London, Ontario, Canada, N6A 5A5
  • Former Serbia and Montenegro
      • Belgrade, Former Serbia and Montenegro, 11000
  • France
      • Bordeaux Cedex, France
      • Nice, France
  • Germany
      • Düsseldorf, Germany, 40225
      • München, Germany, 81675
      • Regensburg, Germany, 93053
      • Tübingen, Germany, 72076
  • India
      • Hyderabad, India
      • Mumbai, India
      • New Delhi, India
  • Israel
      • Jerusalem, Israel, 12000
  • Italy
      • Milano, Italy, 20133
      • Roma, Italy, 185
      • San Donato Milanese, Italy, 20097
  • Mexico
      • Mexico City, Mexico, 14000
      • Mexico City, Mexico, 06700
      • Mexico City, Mexico, 06726
  • Netherlands
      • Leiden, Netherlands, 2300 RC
      • Maastricht, Netherlands, 6202 AZ
      • Rotterdam, Netherlands, 3015 GD
  • Russian Federation
      • Kazan, Russian Federation
      • Moscow, Russian Federation
      • Nizhniy Novgorad, Russian Federation
  • Spain
      • Barcelona, Spain
      • Madrid, Spain
  • Ukraine
      • Kharkov, Ukraine, 61068
      • Kiev, Ukraine
      • Zaporozhye, Ukraine, 69035
  • 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
    • California
      • Sacramento, California, United States, 95817
    • Florida
      • Miami, Florida, United States, 33136
    • Kansas
      • Kansas City, Kansas, United States, 66160-7314
    • New York
      • Rochester, New York, United States, 14607
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7025
    • Ohio
      • Columbus, Ohio, United States, 43210
    • Pennsylvania
      • Upland, Pennsylvania, United States, 19013-3395
    • Texas
      • Dallas, Texas, United States, 75390
      • Galveston, Texas, United States, 77555

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:

  • adult patients 18 to 80 years of age;
  • diagnosis of myasthenia gravis;
  • history of myasthenia weakness involving more than ocular (ie eye) or peri-ocular muscle;
  • duration of myasthenia gravis symptoms (including ocular symptoms) <=10 years;
  • prednisone dose >=20 mg/day (or equivalent alternate-day dose) for >=4 weeks.

Exclusion Criteria:

  • female patients who are pregnant, breastfeeding, or lactating;
  • regularly scheduled plasma exchange (PE) or intravenous immunoglobulin (IVIG) treatment, or PE or IVIG treatment within 2 weeks prior to randomization;
  • any prior clinically significant use of CellCept or other immunosuppressive therapy (except corticosteroids), or within 8 weeks prior to randomization.

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: mycophenolate mofetil (CellCept)
1g bid for 36 weeks
Placebo Comparator: 2
Drug: placebo
po bid for 36 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects reaching responder status
Time Frame: Week 36
Week 36

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to start of response
Time Frame: Event driven
Event driven
Mean and median prednisone dose and cholinesterase inhibitor dose
Time Frame: Week 36
Week 36
Adverse events, lab 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

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche, 973-235-5000

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2004

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

May 19, 2008

First Submitted That Met QC Criteria

May 23, 2008

First Posted (Estimate)

May 26, 2008

Study Record Updates

Last Update Posted (Estimate)

May 26, 2008

Last Update Submitted That Met QC Criteria

May 23, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WX17798

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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