A Continuation Study to Assess the Effect of CellCept in Patients With Myasthenia Gravis. - Full Text View

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 III

MedlinePlus related topics:

Myasthenia Gravis

Drug Information available for:

Prednisone Mycophenolate Mofetil Mycophenolate mofetil hydrochloride

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 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

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
1: Experimental	Drug: mycophenolate mofetil [CellCept] 1g po bid
2: Placebo Comparator	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

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

France

	Bordeaux, France

	Nice, France

Germany

	MÜNCHEN, Germany, 81675

	REGENSBURG, Germany, 93053

Italy

	MILANO, Italy, 20133

	ROMA, Italy, 185

Serbia and Montenegro

	BELGRADE, Serbia and Montenegro, 11000

Ukraine

	KIEV, Ukraine

	KHARKOV, Ukraine, 61068

	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, +1 973 235 5000

More Information

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

Study placed in the following topic categories:

Prednisone

Autoimmune Diseases

Neuromuscular Diseases

Myasthenia gravis

Mycophenolate mofetil

Myasthenia Gravis

Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Immunologic Factors

Immune System Diseases

Physiological Effects of Drugs

Nervous System Diseases

Neuromuscular Junction Diseases

Immunosuppressive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 22, 2008

Sponsors and Collaborators:	Hoffmann-La Roche Aspreva Pharmaceuticals
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00408213