drugset / Trial / NCT07051070

Efficacy and Safety of Rituximab in the Treatment of Anti-Vimentin Antibody-associated Diseases

NCT07051070

Phase 4 Not yet recruiting 40 enrolled Xuanwu Hospital, Beijing
NaSingle-groupOpen-labelTreatment

Summary

In 2025, a novel meningoencephalomyelitis associated with Vimentin IgG in cerebrospinal fluid (CSF) has been identified. Most patients exhibited progressive or recurrent episodes, characterized by prominent cerebellar ataxia, cranial nerve palsies, and pyramidal signs. The characteristic features included bilateral magnetic resonance imaging (MRI) lesions of the corticospinal tract, elevated CSF protein levels, and increased CSF cell counts. Despite receiving immunotherapy, these patients experienced significant disability. This study employed a single-center, open-label, single-arm design to investigate the clinical efficacy and safety of rituximab (RTX) treatment in 40 patients with vimentin antibody (VIMA)-related diseases.

Timeline

Start
2025-07-01
Primary completion
2026-10-01
Completion
2026-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody 375 mg/m2

Indications