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

Myasthenia Gravis, Generalized Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00683969
• Other study ID #: WX17798
• Status: Completed
• Phase: Phase 3
• First received: May 19, 2008
• Last updated: May 23, 2008
• Start date: August 2004
• Est. completion date: May 2007

Study information

• Verified date: May 2008
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00090636

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myasthenia Gravis
• Myasthenia Gravis, Generalized

Intervention

Drug:
• mycophenolate mofetil (CellCept)
1g bid for 36 weeks
• placebo
po bid for 36 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	Aspreva Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Former Serbia and Montenegro,  France,  Germany,  India,  Israel,  Italy,  Mexico,  Netherlands,  Russian Federation,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects reaching responder status		Week 36	No
Secondary	Time to start of response		Event driven	No
Secondary	Mean and median prednisone dose and cholinesterase inhibitor dose		Week 36	No
Secondary	Adverse events, lab parameters, vital signs		Throughout study	No