MedTrace Logo

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

NCT07051070 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-07-03

No results posted yet for this study

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.

Conditions

  • Anti-Vimentin Antibody-associated Diseases
  • Meningoencephalomyelitis Associated With Vimentin IgG Autoantibodies

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.

Sponsors & Collaborators

  • Xuanwu Hospital, Beijing

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07051070 on ClinicalTrials.gov