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

This study has been completed.
Sponsor:
Collaborator:
Aspreva Pharmaceuticals
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00408213
First received: December 5, 2006
Last updated: May 22, 2008
Last verified: May 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00408213     History of Changes
Obsolete Identifiers: NCT00231088
Other Study ID Numbers: WX18411
Study First Received: December 5, 2006
Last Updated: May 22, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Myasthenia Gravis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Immune System Diseases
Nervous System Diseases
Neuromuscular Diseases
Neuromuscular Junction Diseases
Mycophenolate mofetil
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014