A Randomized, Double-Blind, Placebo-Controlled, Multi-Cen... | EligiMed

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG)

CompletadoFase 3ClinicalTrials.gov

ID: NCT01997229RENIS: IS001147Tipo: INTERVENTIONALInicio: 1 de dic de 2013Fin estimado: 1 de jun de 2016

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine if eculizumab is safe and effective for the treatment of refractory generalized Myasthenia Gravis.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Male or female patients ≥18 years old
Diagnosis of MG made by the following tests:
Positive serologic test for anti-AChR Abs as confirmed at screening, and
One of the following:
History of abnormal neuromuscular transmission test demonstrated by single-fiber electromyography (SFEMG) or repetitive nerve stimulation, or
History of positive anticholinesterase test, e.g. edrophonium chloride test, or
Subject has demonstrated improvement in MG signs on oral cholinesterase inhibitors, as assessed by the treating physician.
MGFA Clinical Classification Class II to IV at screening.
MG-ADL total score must be ≥6 at screening and Randomization (Day 1).
Subjects who have:
Failed treatment with at least two immunosuppressive agents. Or,
Failed treatment with at least one immunosuppressive agent and require chronic plasma exchange or IVIg

Criterios de exclusión

MGFA Class I or MG crisis at screening (MGFA Class V)
Use of rituximab within 6 months prior to screening
Use of IVIg or PE within 4 weeks prior to Randomization (Day 1)
History of thymoma or other neoplasms of the thymus
History of thymectomy within 12 months prior to screening

Intervenciones

biological

Eculizumab

Induction Phase: 900 mg IV weekly X 4 Maintenance Phase: 1200 mg IV every 2 weeks during Weeks 4-26

drug

Placebo

Ubicaciones

Hospital Italiano

Ciudad Autonoma, Buenos Aires, Argentina

Instituto de Investigaciones Neurologicas Raul Carrea, FLENI

Ciudad Autonoma, Buenos Aires, Argentina

Patrocinadores

PrincipalAlexion Pharmaceuticals, Inc.

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