Trials / Not Yet Recruiting
Not Yet RecruitingNCT07051070
Efficacy and Safety of Rituximab in the Treatment of Anti-Vimentin Antibody-associated Diseases
- Status
- Not Yet Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Xuanwu Hospital, Beijing · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-07-01
- Primary completion
- 2026-10-01
- Completion
- 2026-11-01
- First posted
- 2025-07-03
- Last updated
- 2025-07-03
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07051070. Inclusion in this directory is not an endorsement.