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OpenTrials
Completed

NCT Number: NCT00683969

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

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Key information

Conditions

Myasthenia Gravis, Generalized Autoimmune Diseases Autoimmune Diseases of the Nervous System Immune System Diseases Myasthenia Gravis Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mycophenolate Mofetil (cellcept)

Drug

1g bid for 36 weeks

Placebo

Drug

po bid for 36 weeks

Primary outcomes

  1. Proportion of subjects reaching responder status

    Time frame: Week 36

Secondary outcomes

  1. Time to start of response

    Time frame: Event driven

  2. Mean and median prednisone dose and cholinesterase inhibitor dose

    Time frame: Week 36

  3. Adverse events, lab parameters, vital signs

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Collaborators

  • Aspreva Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2007
First posted
May 26, 2008
Registry last updated
May 26, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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