A Study to Assess the Effect of CellCept (Mycophenolate M... | NCT00683969

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

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2004

Primary Completion Date

Not provided

Completion Date

May 2007Actual

First Submitted Date

May 19, 2008

First Submission Date that Met QC Criteria

May 23, 2008

First Posted Date

May 26, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2008

Last Update Posted Date

May 26, 2008Estimated

Name	Class
Aspreva Pharmaceuticals	INDUSTRY

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

136Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: mycophenolate mofetil (CellCept)
2	Placebo Comparator		Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mycophenolate mofetil (CellCept)	Drug	1g bid for 36 weeks	1
placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of subjects reaching responder status		Week 36

Secondary Outcomes

Measure	Description	Time Frame
Time to start of response		Event driven
Mean and median prednisone dose and cholinesterase inhibitor dose		Week 36
Adverse events, lab parameters, vital signs

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche, 973-235-5000	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Sun City	Arizona		United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25032816	Derived	Sengupta M, Cheema A, Kaminski HJ, Kusner LL; Muscle Study Group. Serum metabolomic response of myasthenia gravis patients to chronic prednisone treatment. PLoS One. 2014 Jul 17;9(7):e102635. doi: 10.1371/journal.pone.0102635. eCollection 2014.

ID	Term
D020361	Paraneoplastic Syndromes, Nervous System
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010257	Paraneoplastic Syndromes
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D019636	Neurodegenerative Diseases
D020511	Neuromuscular Junction Diseases
D009468	Neuromuscular Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D002208	Caproates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D005227	Fatty Acids
D008055	Lipids