Trial information
A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Controlling Symptoms of Myasthenia Gravis
Status: No longer recruiting
Protocol number: WX17798
Sponsor: Hoffmann-La Roche; Aspreva Pharmaceuticals Corporation
Company division: Pharmaceutical
Official Scientific Title: A prospective, randomised, 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 myastenia gravis.
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.
Target sample size is
136.
Study phase: III
Study type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety/Efficacy study
Condition: Myasthenia Gravis generalised
Intervention type: Drug
Intervention name: mycophenolate mofetil [CellCept]
Primary outcome: 1. Proportion of subjects reaching responder status
Time frame: Week 36
Key secondary outcomes: 1. Time to start of response
Time frame: Event driven
2. Mean and median prednisone dose and cholinesterase inhibitor dose Time frame: Week 36
3. Adverse events, lab parameters, vital signs Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: 80 Years
Accepts healthy volunteers: No
Anticipated start date: August, 2004
Trial registration date: 05/23/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Canada
- Edmonton, AB
- London, ON
- Montreal, QC
Czech Republic
Germany
- Düsseldorf
- Frankfurt Am Main
- München
- Regensburg
- Tübingen
Israel
Italy
- Milano
- Roma
- San Donato Milanese
Mexico
- Guadalajara, Jalisco
- Mexico City
Netherlands
- Leiden
- Maastricht
- Rotterdam
Ukraine
- Dnipropetrovs'K
- Kharkov
- Kiev
- Zaporozhye
United Kingdom
- Bristol
- Liverpool
- Oxford
- Salford
United States
- Birmingham, AL
- Sacramento, CA
- Miami, FL
- Chicago, IL
- Kansas City, KS
- New York, NY
- Rochester, NY
- Chapel Hill, NC
- Durham, NC
- Columbus, OH
- Upland, PA
- Dallas, TX
- Galveston, TX
