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)
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)
The purpose of this study is to determine if eculizumab is safe and effective for the treatment of refractory generalized Myasthenia Gravis.
Key Inclusion Criteria:
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:
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:
Key Exclusion Criteria:
New York, New York 10021, United States
Ciudad Autonoma, Buenos Aires 1181, Argentina
Ciudad Autonoma, Buenos Aires C1428AQK, Argentina
São José do Rio Preto, São Paulo 15090-000, Brazil
Rio de Janeiro, 21941-913, Brazil
Ostrava - Poruba, 708 52, Czechia
Hanamaki-shi, Iwate 025-0075, Japan
Osakasayama-shi, Osaka 589-8511, Japan
Suita-shi, Osaka 565-0871, Japan
Meguro-ku, Tokyo-To 153-8515, Japan
Ube-shi, Yamaguchi 755-8505, Japan