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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
Xuanwu Hospital, Capital Medical University
Beijing, China
Change in Expanded Disability Status Scale (EDSS) score from baseline
Change in Expanded Disability Status Scale (EDSS) score from baseline at week 48 after treatment (EDSS:Minimum Score 0, Maximum score 10, higher scores mean a worse outcome)
Time frame: baseline, week 48 after treatment.
Annualized Relapse Rate (ARR)
ARR is lower, the better.
Time frame: Week 48 after treatment
The event of confirmed disability progression (CDP)
An increase of ≥1.0 points for baseline EDSS scores ≤5.5, or an increase of ≥0.5 points for baseline EDSS \>5.5 is referred to as CDP.
Time frame: Week 48 after treatment
Change in modified Rankin Scale (mRS) score from baseline
Change in modified Rankin Scale (mRS) score from baseline at week 48 after treatment (mRS: Minimum Score 0, Maximum score 6, higher scores mean a worse outcome )
Time frame: baseline, week 48 after treatment
Change in time taken to complete the Timed 25-Foot Walk (T25FW) from baseline
Change in time taken to complete the Timed 25-Foot Walk (T25FW) from baseline at week 48 after treatment. The time of T25FW is shorter, the better.
Time frame: baseline, week 48 after treatment
Change in EQ-5D-5L scores from baseline
Change in EQ-5D-5L scores from baseline at week 48 after treatment(EQ-5D-5L: Minimum Score 5, Maximum score 25, lower scores mean a better quality of life )
Time frame: baseline, week 48 after treatment
Changes in scale for the assessment and rating of ataxia (SARA) from baseline
Changes in scale for the assessment and rating of ataxia (SARA) from baseline at week 48 after treatment(SARA: Minimum Score 0, Maximum score 40, higher scores mean a worse outcome)
Time frame: baseline, week 48 after treatment
Change in Scores of International Cooperative Ataxia Rating Scale (ICARS) from baseline
Change in Scores of International Cooperative Ataxia Rating Scale (ICARS) from baseline at week 48 after treatment(ICARS: Minimum Score 0, Maximum Score 100, higher scores mean a worse outcome)
Time frame: baseline, week 48 after treatment
Number of New, and/or Enlarging T2 Hyperintense Lesions Detected by Magnetic Resonance Imaging (MRI) of brain and spinal cord
Number of new, and/or enlarging T2 hyperintense lesions detected by Magnetic Resonance Imaging (MRI) of brain and spinal cord at week 48 after treatment
Time frame: baseline, week 48 after treatment
Adverse events
Adverse events during use of RTX
Time frame: through study completion, an average of 2 year
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