Trial record 45 of 50 for:    Neuromuscular Manifestations | "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

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

  Show 43 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Aspreva Pharmaceuticals
Study Director: Clinical Trials Hoffmann-La Roche, 973-235-5000

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche Identifier: NCT00683969     History of Changes
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:
Myasthenia Gravis
Neuromuscular Manifestations
Neurologic Manifestations
Neuromuscular Junction Diseases
Neuromuscular Diseases
Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Autoimmune Diseases of the Nervous System
Autoimmune Diseases
Immune System Diseases
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action