Efficacy of Ocrelizumab in Autoimmune Encephalitis
Status:
Terminated
Trial end date:
2020-10-02
Target enrollment:
Participant gender:
Summary
This pilot study is a randomized, double-blind, placebo controlled study of the efficacy of
ocrelizumab in autoimmune encephalitis. Subjects with new diagnosis of autoimmune
encephalitis will be invited to enroll in this study. Subjects will be randomized to receive
ocrelizumab (an anti-CD20 therapy) or matched placebo, and will undergo three infusions over
a six month period. Subjects will complete clinical visits over the study period, during
which safety monitoring and neuropsychological assessments will be performed to assess for
signs of clinical worsening from encephalitis. The primary outcome of this study is the
proportion of patients who fail to complete the twelve month period without clinical
worsening, as defined by the protocol. Subjects who experience early clinical worsening
during the study may be offered open-label treatment with ocrelizumab at the discretion of
the investigators.