Efficacy of Ocrelizumab in Autoimmune Encephalitis

Status Terminated

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03835728
Study type	Interventional
Source	University of Texas Southwestern Medical Center
Contact
Status	Terminated
Phase	Phase 2
Start date	January 22, 2019
Completion date	October 2, 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04561557` - Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Inflammatory Diseases of the Nervous System	Early Phase 1
Completed	`NCT05645185` - Characterisation of Clinical Phenotypes and Outcomes of Ma2 Patient
Completed	`NCT04708626` - Epidemiology of Autoimmune Encephalitides and Paraneoplastic Neurological Syndromes in Sweden
Not yet recruiting	`NCT04106596` - HLA Analysis in Autoimmune Encephalitis and Related Disorders
Not yet recruiting	`NCT05711563` - Predicting and Monitoring Outcomes in Autoimmune Encephalitis
Completed	`NCT04175522` - Safety and Efficacy of IGIV 10% in Patients With Autoimmune Encephalitis:	Phase 2
Recruiting	`NCT03194815` - IVIG and Rituximab in Antibody-associated Psychosis - SINAPPS2	Phase 2
Recruiting	`NCT06079294` - Impact of Confirmed Autoimmune Encephalitis on Brain Glucose Metabolism	N/A
Not yet recruiting	`NCT03957616` - Incidence of Paraneoplastic Neurological Syndromes and Autoimmune Encephalitis
Completed	`NCT02905136` - Mechanisms of Auto-immune Encephalitis
Recruiting	`NCT05280600` - Developing Advanced Neuroimaging for Clinical Evaluation of Autoimmune Encephalitis
Recruiting	`NCT06173076` - A Prospective Study to Evaluate Clinical Outcomes in Anti-LGI1 Encephalitis
Recruiting	`NCT03993262` - Trial to Evaluate Efficacy and Safety of Bortezomib in Patients With Severe Autoimmune Encephalitis	Phase 2
Recruiting	`NCT06033846` - Efficacy and Safety of Adjunctive Minocycline in the Treatment of Autoimmune Encephalitis	Phase 2
Recruiting	`NCT04372615` - The ExTINGUISH Trial of Inebilizumab in NMDAR Encephalitis	Phase 2
Recruiting	`NCT05177939` - Phase III Clinical Study of NPB-01 in Patients With Autoimmune Encephalitis	Phase 3
Active, not recruiting	`NCT06432803` - Metabolic Imaging for Diagnosis and Prognostication of Autoimmune encephalitiS
Recruiting	`NCT06019975` - FDG-PET in the Diagnosis of Autoimmune Encephalitis
Completed	`NCT05783947` - Diagnostic Performance of a Commercial Assay for the Detection of Neuronal Antibodies
Not yet recruiting	`NCT06456736` - Clinical Features and Prognostic Markers in Adult Patients With AE Requiring ICU Treatment