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

This study has been completed.
Sponsor:
Collaborator:
Aspreva Pharmaceuticals
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00683969
First received: May 19, 2008
Last updated: May 23, 2008
Last verified: May 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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
Experimental: 1 Drug: mycophenolate mofetil (CellCept)
1g bid for 36 weeks
Placebo Comparator: 2 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00683969     History of Changes
Obsolete Identifiers: NCT00090636
Other Study ID Numbers: WX17798
Study First Received: May 19, 2008
Last Updated: May 23, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Myasthenia Gravis
Muscle Weakness
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Mycophenolate mofetil
Mycophenolic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014