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

Last updated: May 23, 2008
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

Polymyositis (Inflammatory Muscle Disease)

Sarcopenia

Neuropathy

Treatment

N/A

Clinical Study ID

NCT00683969
WX17798
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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-ocularmuscle;

  • duration of myasthenia gravis symptoms (including ocular symptoms) <=10 years;

  • prednisone dose >=20 mg/day (or equivalent alternate-day dose) for >=4 weeks.

Exclusion

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 Design

Total Participants: 136
Study Start date:
August 01, 2004
Estimated Completion Date:
May 31, 2007

Connect with a study center

  • Edmonton, Alberta T6G 2B7
    Canada

    Site Not Available

  • London, Ontario N6A 5A5
    Canada

    Site Not Available

  • Belgrade, 11000
    Former Serbia and Montenegro

    Site Not Available

  • Bordeaux Cedex,
    France

    Site Not Available

  • Nice,
    France

    Site Not Available

  • empty

    Düsseldorf, 40225
    Germany

    Site Not Available

  • Düsseldorf, 40225
    Germany

    Site Not Available

  • empty

    München, 81675
    Germany

    Site Not Available

  • München, 81675
    Germany

    Site Not Available

  • Regensburg, 93053
    Germany

    Site Not Available

  • empty

    Tübingen, 72076
    Germany

    Site Not Available

  • Tübingen, 72076
    Germany

    Site Not Available

  • Hyderabad,
    India

    Site Not Available

  • Mumbai,
    India

    Site Not Available

  • New Delhi,
    India

    Site Not Available

  • Jerusalem, 12000
    Israel

    Site Not Available

  • Milano, 20133
    Italy

    Site Not Available

  • Roma, 185
    Italy

    Site Not Available

  • San Donato Milanese, 20097
    Italy

    Site Not Available

  • Mexico City, 06726
    Mexico

    Site Not Available

  • Leiden, 2300 RC
    Netherlands

    Site Not Available

  • Maastricht, 6202 AZ
    Netherlands

    Site Not Available

  • Rotterdam, 3015 GD
    Netherlands

    Site Not Available

  • Kazan,
    Russian Federation

    Site Not Available

  • Moscow,
    Russian Federation

    Site Not Available

  • Nizhniy Novgorad,
    Russian Federation

    Site Not Available

  • Barcelona,
    Spain

    Site Not Available

  • Madrid,
    Spain

    Site Not Available

  • Kharkov, 61068
    Ukraine

    Site Not Available

  • Kiev,
    Ukraine

    Site Not Available

  • Zaporozhye, 69035
    Ukraine

    Site Not Available

  • Liverpool, L9 1AE
    United Kingdom

    Site Not Available

  • Oxford, OX2 6HE
    United Kingdom

    Site Not Available

  • Salford, M6 8HD
    United Kingdom

    Site Not Available

  • Sun City, Arizona
    United States

    Site Not Available

  • Sacramento, California 95817
    United States

    Site Not Available

  • Miami, Florida 33136
    United States

    Site Not Available

  • Kansas City, Kansas 66160-7314
    United States

    Site Not Available

  • Rochester, New York 14607
    United States

    Site Not Available

  • Chapel Hill, North Carolina 27599-7025
    United States

    Site Not Available

  • Columbus, Ohio 43210
    United States

    Site Not Available

  • Upland, Pennsylvania 19013-3395
    United States

    Site Not Available

  • Dallas, Texas 75390
    United States

    Site Not Available

  • Galveston, Texas 77555
    United States

    Site Not Available

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