Adjunct CellCept (Mycophenolate Mofetil) With Reduced Corticosteroids in Subjects With Myasthenia Gravis

This study has been completed.

First Received: August 31, 2004 Last Updated: April 8, 2008 History of Changes

Sponsors and Collaborators:	Hoffmann-La Roche as part of the Aspreva Rare Disease Program
Information provided by:	Aspreva Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00090636

Purpose

Myasthenia gravis is a rare, debilitating neurological autoimmune disease. Mycophenolate mofetil (MMF) modulates autoimmune responses through a unique mode of action which may be relevant for autoimmune disease patients. This study will test the safety and efficacy of adjunct MMF to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis.

Condition	Intervention	Phase
Myasthenia Gravis	Drug: mycophenolate mofetil	Phase III

MedlinePlus related topics: Autoimmune Diseases Myasthenia Gravis

Drug Information available for: Mycophenolate mofetil hydrochloride Mycophenolate Mofetil Corticosteroids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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 Corticosteroids in Subjects With Myasthenia Gravis

Further study details as provided by Aspreva Pharmaceuticals:

Estimated Enrollment:	136
Study Start Date:	March 2004
Study Completion Date:	August 2006

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Major Inclusion Criteria:

Clinical diagnosis of myasthenia gravis (MG)
Duration of MG symptoms less than or equal to 10 years
Requirement of immunosuppressive therapy
Treatment with prednisone for at least 4 weeks

Major Exclusion Criteria:

Currently taking CellCept (mycophenolate mofetil) or other immunosuppressants other than prednisone
Thymoma
Thymectomy within 6 months of randomization
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090636

Locations

United States, Alabama

Birmingham, Alabama, United States
United States, California
University of California Davis Medical Center
Davis, California, United States, 95817
United States, Florida

Miami, Florida, United States
United States, Illinois

Chicago, Illinois, United States
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642

New York, New York, United States
United States, North Carolina
UNC Hospitals, UNC-Chapel Hill Department of Neurology
Chapel Hill, North Carolina, United States, 27599-7025

Durham, North Carolina, United States
United States, Ohio
Ohio State University School of Medicine
Columbus, Ohio, United States, 43210
United States, Pennsylvania

Upland, Pennsylvania, United States
United States, Texas
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390

Galveston, Texas, United States
Canada, Alberta

Edmonton, Alberta, Canada
Canada, Ontario

London, Ontario, Canada
Canada, Quebec

Montreal, Quebec, Canada

Sponsors and Collaborators

Hoffmann-La Roche

as part of the Aspreva Rare Disease Program

More Information

No publications provided

Study ID Numbers:	WX17798
Study First Received:	August 31, 2004
Last Updated:	April 8, 2008
ClinicalTrials.gov Identifier:	NCT00090636 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Aspreva Pharmaceuticals:

Autoimmune
mycophenolate mofetil
corticosteroid

Study placed in the following topic categories:

Anti-Bacterial Agents
Autoimmune Diseases
Immunologic Factors
Neuromuscular Diseases
Mycophenolic Acid

Mycophenolate mofetil
Benzocaine
Myasthenia Gravis
Immunosuppressive Agents
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Autoimmune Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Nervous System Diseases
Physiological Effects of Drugs
Mycophenolic Acid
Enzyme Inhibitors

Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions
Neuromuscular Diseases
Therapeutic Uses
Mycophenolate mofetil
Neuromuscular Junction Diseases
Myasthenia Gravis
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on May 06, 2009