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

This study has been completed.

First Received: May 19, 2008 Last Updated: May 23, 2008 History of Changes

Sponsors and Collaborators:	Hoffmann-La Roche Aspreva Pharmaceuticals
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00683969

Purpose

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	Intervention	Phase
Myasthenia Gravis, Generalized	Drug: mycophenolate mofetil (CellCept) Drug: placebo	Phase III

MedlinePlus related topics: 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 (Subject, Investigator), 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 Corticosteroid in Subjects With Myasthenia Gravis

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Proportion of subjects reaching responder status [ Time Frame: Week 36 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to start of response [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Mean and median prednisone dose and cholinesterase inhibitor dose [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
Adverse events, lab parameters, vital signs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	136
Study Start Date:	August 2004
Study Completion Date:	May 2007

Arms	Assigned Interventions
1: Experimental	Drug: mycophenolate mofetil (CellCept) 1g bid for 36 weeks
2: Placebo Comparator	Drug: placebo po bid for 36 weeks

Eligibility

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683969

Show 43 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Aspreva Pharmaceuticals

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, 973-235-5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	WX17798
Study First Received:	May 19, 2008
Last Updated:	May 23, 2008
ClinicalTrials.gov Identifier:	NCT00683969 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Autoimmune Diseases
Immunologic Factors
Benzocaine
Mycophenolic Acid
Immunosuppressive Agents
Naphazoline
Anti-Bacterial Agents

Neuromuscular Diseases
Guaifenesin
Mycophenolate mofetil
Myasthenia Gravis
Phenylpropanolamine
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 07, 2009