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A Continuation Study to Assess the Effect of CellCept in Patients With Myasthenia Gravis.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00408213
First Posted: December 6, 2006
Last Update Posted: May 23, 2008
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.
Collaborator:
Aspreva Pharmaceuticals
Information provided by:
Hoffmann-La Roche
  Purpose
This 2 arm study will provide optional continuation of double-blind treatment with CellCept or placebo, in patients with myasthenia gravis who have achieved good symptom control in study WX17798. Patients who have completed 36 weeks of treatment in study WX17798, with stable prednisone dosing for the last 4 weeks, can continue on blinded treatment with CellCept (1g bid) or placebo until the database for WX17798 is locked and unblinded. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Condition Intervention Phase
Myasthenia Gravis Generalised Drug: mycophenolate mofetil [CellCept] Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Study to Evaluate the Safety of Continued Treatment With CellCept in Patients With Well-Controlled Myasthenia Gravis Receiving a Stable Dose of Prednisone

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • AEs, laboratory parameters, vital signs. [ Time Frame: Throughout study ]

Estimated Enrollment: 136
Study Start Date: June 2004
Study Completion Date: September 2007
Arms Assigned Interventions
Experimental: 1 Drug: mycophenolate mofetil [CellCept]
1g po bid
Placebo Comparator: 2 Drug: Placebo
po bid

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • subjects who have completed 36 weeks of treatment in study WX17798, and who have demonstrated good symptom control with a stable prednisone dose for the final 4 weeks of that study.

Exclusion Criteria:

  • regularly scheduled plasma exchange or intravenous immunoglobulin treatment;
  • medical condition, adverse event or intolerance of double-blind treatment which would preclude continuation.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00408213


Locations
United States, Arizona
Sun City, Arizona, United States, 85351
United States, California
Sacramento, California, United States, 95817
United States, Pennsylvania
Upland, Pennsylvania, United States, 19013
Former Serbia and Montenegro
Belgrade, Former Serbia and Montenegro, 11000
France
Bordeaux, France
Nice, France
Germany
München, Germany, 81675
Regensburg, Germany, 93053
Italy
Milano, Italy, 20133
Roma, Italy, 185
Ukraine
Kharkov, Ukraine, 61068
Kiev, Ukraine
Zaporozhye, Ukraine
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
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00408213     History of Changes
Obsolete Identifiers: NCT00231088
Other Study ID Numbers: WX18411
First Submitted: December 5, 2006
First Posted: December 6, 2006
Last Update Posted: May 23, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Muscle Weakness
Myasthenia Gravis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Autoimmune Diseases of the Nervous System
Neuromuscular Junction Diseases
Neuromuscular Diseases
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