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

Last updated: May 22, 2008
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

Neuropathy

Polymyositis (Inflammatory Muscle Disease)

Myasthenia Gravis Generalised

Treatment

N/A

Clinical Study ID

NCT00408213
WX18411
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • subjects who have completed 36 weeks of treatment in study WX17798, and who havedemonstrated good symptom control with a stable prednisone dose for the final 4 weeksof that study.

Exclusion

Exclusion Criteria:

  • regularly scheduled plasma exchange or intravenous immunoglobulin treatment;

  • medical condition, adverse event or intolerance of double-blind treatment which wouldpreclude continuation.

Study Design

Total Participants: 136
Study Start date:
June 01, 2004
Estimated Completion Date:
September 30, 2007

Connect with a study center

  • Belgrade, 11000
    Former Serbia and Montenegro

    Site Not Available

  • Bordeaux,
    France

    Site Not Available

  • Nice,
    France

    Site Not Available

  • empty

    München, 81675
    Germany

    Site Not Available

  • München, 81675
    Germany

    Site Not Available

  • Regensburg, 93053
    Germany

    Site Not Available

  • Milano, 20133
    Italy

    Site Not Available

  • Roma, 185
    Italy

    Site Not Available

  • Kharkov, 61068
    Ukraine

    Site Not Available

  • Kiev,
    Ukraine

    Site Not Available

  • Zaporozhye,
    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 85351
    United States

    Site Not Available

  • Sacramento, California 95817
    United States

    Site Not Available

  • Upland, Pennsylvania 19013
    United States

    Site Not Available

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