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NOT YET RECRUITING
NCT07051070
PHASE4

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

Sponsor: Xuanwu Hospital, Beijing

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-07-01

Completion Date

2026-11-01

Last Updated

2025-07-03

Healthy Volunteers

No

Interventions

DRUG

RTX treatment

This study used a drug dosage based on previous domestic and international literature as well as clinical experience from our center, set at 375mg/m2 per dose. During the course of the disease, TB lymphocyte subsets are monitored, and if the proportion of B lymphocytes is greater than or equal to 1%, a second dose will be administered.

Locations (1)

Xuanwu Hospital, Capital Medical University

Beijing, China