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Trial record 3 of 9 for:    mycophenolate mofetil | Myasthenia Gravis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00683969
Recruitment Status : Completed
First Posted : May 26, 2008
Last Update Posted : May 26, 2008
Aspreva Pharmaceuticals
Information provided by:
Hoffmann-La Roche

Brief 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.

Condition or disease Intervention/treatment Phase
Myasthenia Gravis, Generalized Drug: mycophenolate mofetil (CellCept) Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : August 2004
Actual Study Completion Date : May 2007

Arm Intervention/treatment
Experimental: 1 Drug: mycophenolate mofetil (CellCept)
1g bid for 36 weeks

Placebo Comparator: 2 Drug: placebo
po bid for 36 weeks

Primary Outcome Measures :
  1. Proportion of subjects reaching responder status [ Time Frame: Week 36 ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00683969

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United States, Arizona
Sun City, Arizona, United States
United States, California
Sacramento, California, United States, 95817
United States, Florida
Miami, Florida, United States, 33136
United States, Kansas
Kansas City, Kansas, United States, 66160-7314
United States, New York
Rochester, New York, United States, 14607
United States, North Carolina
Chapel Hill, North Carolina, United States, 27599-7025
United States, Ohio
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Upland, Pennsylvania, United States, 19013-3395
United States, Texas
Dallas, Texas, United States, 75390
Galveston, Texas, United States, 77555
Canada, Alberta
Edmonton, Alberta, Canada, T6G 2B7
Canada, Ontario
London, Ontario, Canada, N6A 5A5
Former Serbia and Montenegro
Belgrade, Former Serbia and Montenegro, 11000
Bordeaux Cedex, France
Nice, France
Düsseldorf, Germany, 40225
München, Germany, 81675
Regensburg, Germany, 93053
Tübingen, Germany, 72076
Hyderabad, India
Mumbai, India
New Delhi, India
Jerusalem, Israel, 12000
Milano, Italy, 20133
Roma, Italy, 185
San Donato Milanese, Italy, 20097
Mexico City, Mexico, 06700
Mexico City, Mexico, 06726
Mexico City, Mexico, 14000
Leiden, Netherlands, 2300 RC
Maastricht, Netherlands, 6202 AZ
Rotterdam, Netherlands, 3015 GD
Russian Federation
Kazan, Russian Federation
Moscow, Russian Federation
Nizhniy Novgorad, Russian Federation
Barcelona, Spain
Madrid, Spain
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
Sponsors and Collaborators
Hoffmann-La Roche
Aspreva Pharmaceuticals
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Study Director: Clinical Trials Hoffmann-La Roche, 973-235-5000
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche Identifier: NCT00683969    
Obsolete Identifiers: NCT00090636
Other Study ID Numbers: WX17798
First Posted: May 26, 2008    Key Record Dates
Last Update Posted: May 26, 2008
Last Verified: May 2008
Additional relevant MeSH terms:
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Myasthenia Gravis
Mycophenolic Acid
Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
Neoplasms by Site
Paraneoplastic Syndromes
Autoimmune Diseases of the Nervous System
Neurodegenerative Diseases
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action