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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00683969
• Date of registration: 19/05/2008
• Prospective Registration: No
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Controlling Symptoms of Myasthenia Gravis
• Scientific 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
• Date of first enrolment: August 2004
• Target sample size: 136
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00683969
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche, 973-235-5000

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Myasthenia Gravis, Generalized

Intervention(s)

Drug: placebo

Drug: mycophenolate mofetil (CellCept)

Primary Outcome(s)

Proportion of subjects reaching responder status [Time Frame: Week 36]

Secondary Outcome(s)

Time to start of response [Time Frame: Event driven]

Adverse events, lab parameters, vital signs [Time Frame: Throughout study]

Mean and median prednisone dose and cholinesterase inhibitor dose [Time Frame: Week 36]

Secondary ID(s)

WX17798

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Aspreva Pharmaceuticals