Trial Information

Summary: 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 Design / Study Details:

  • Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double Blind
  • Control: Placebo
  • Assignment: Parallel
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

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: 08/18/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Upland, PA 19013
Telephone: 973-235-5000 or 800-526-6367

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Trial listings updated: August 20, 2008 at 2:20:44 PM


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