EUCTR2004-000596-34-CZ
Active, not recruiting
Not Applicable
A prospective, randomized, double-blind, placebo controlled, parallel group, multicenter, 36-weeks trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptoms control with reduced corticosteroids in subjects with mysthenia gravis
DrugsCellCept 500 mg
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myasthenia gravis
- Sponsor
- F.Hoffmann-La Roche Ltd.
- Enrollment
- 136
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject of either sex, 18 to 80 years of age (inclusive)
- •diagnosis of MG meeting all of the following criteria:
- •history of myasthenic weakness involving more than ocular or
- •peri\-ocular muscles
- •history of positive edrophonium chloride test OR abnormal
- •neuromuscular transmission demonstrated by electrodiagnostic
- •history of elevated AChR antibodies
- •disease severity history: Myasthenia Gravis Foundation of
- •America (MGFA) classification II, III, or IVa
- •duration of MG symptoms (including ocular symptoms) \= 10
Exclusion Criteria
- •pregnancy, breastfeeding, or lactation
- •receiving regularly scheduled plasma exchange (PE) or
- •intravenous immunoglobulin (IVIG) treatment or receiving PE or
- •IVIG treatment within 2 weeks prior to randomization
- •receiving MMF or other immunosuppressant therapy (except
- •corticosteroids) within 8 weeks prior to randomization
- •any prior clinically significant use of MMF or other
- •immunosuppressant therapy (except corticosteroids)
- •severe weakness of oropharyngeal and/or respiratory muscles
- •(MGFA Class IVb or V; compromised airway protection; MG
Outcomes
Primary Outcomes
Not specified
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