Anti-Vimentin Antibody-associated DiseasesPhase 4NCT07051070
Efficacy and Safety of Rituximab in the Treatment of Anti-Vimentin Antibody-associated Diseases
A Phase 4 study testing RTX treatment in people with Anti-Vimentin Antibody-associated Diseases and Meningoencephalomyelitis Associated With Vimentin IgG Autoantibodies, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anti-Vimentin Antibody-associated Diseases, Meningoencephalomyelitis Associated With Vimentin IgG Autoantibodies
- What is being tested?
- RTX treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 1 Nov 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years, no gender restrictions;
- Patients with positive CSF anti-Vimentin antibodies（VIMA）, clinically consistent with the clinical features of VIMA-related diseases reported in JAMA Neurology 2024; 3. EDSS ≥ 3.5 points or evidence of disease activity as defined by the protocol within 1 year prior to screening.
- Evidence of disease activity as defined by the protocol: One of the following manifestations within 6 months of the screening period: 1. Enlargement of lesions on brain or spinal cord MRI T2 sequence; 2. △EDSS > 0; 3. At least two FS scores increase by 1 point or at least 1 FS increases by 2 points (excluding rectal/bladder and brain); 4. Symptoms lasting for more than 24 hours without fever and more than 30 days since the last episode. 4. Sign informed consent.
Who cannot join
- Allergy to the study drug;
- Known active infections during the screening period (excluding nail bed fungal infections or dental caries);
- Underwent any surgical procedure within 4 weeks prior to screening, has evidence of other demyelinating diseases or progressive multifocal leukoencephalopathy (PML);
- Positive serology for HIV or syphilis treponema or RPR during the screening period (if syphilis antibodies are negative, further serological testing for syphilis is not required);
- Chronic hepatitis B virus or hepatitis C virus infection that meets the following criteria: • HBsAg positive; • If HBsAg negative, HbcAb positive, further HBV DNA testing (result ≥1000 IU/mL); • If HCV antibody testing is positive, further HCV RNA testing (result above the upper limit of normal range at the research site);
- Evidence of active tuberculosis (excluding patients receiving medication for latent TB infection);
Show all 18Show fewer
- Received any live vaccine or attenuated live vaccine within 6 weeks prior to the medication;
- History of malignant tumors within 5 years prior to screening, including solid tumors, hematological malignancies, and carcinoma in situ (excluding fully resected and cured basal cell carcinoma, squamous cell carcinoma, and cervical carcinoma in situ);
- Pregnant or breastfeeding women; for women of childbearing potential, a positive serum pregnancy test at screening, or unwilling to use reliable contraception (physical barriers [patient or partner] and spermicide, contraceptive pills, patches, injections, intrauterine devices or systems), and continuing for at least 4 months after the last administration of the study drug. Men of childbearing potential unwilling to use effective contraceptive measures during the period from signing the informed consent to 6 months after the last medication;
- Any other diseases determined by the investigator that would make the subject unsuitable for participation in this study;
- Presence of the following clinically significant diseases:
- Echocardiography during the screening period shows a left ventricular ejection fraction (EF) below 50% or below the lower limit of normal values at the research center; history of chronic congestive heart failure, functional class NYHA III-IV;
- Any of the following events occurred within 3 months prior to signing the informed consent: myocardial infarction, acute coronary syndrome, viral myocarditis, pulmonary embolism, stroke; coronary revascularization surgery within 6 months;
- Electrocardiogram during the screening period indicates QTc interval >480ms (according to Fridericia's correction formula, where QTc=QT/RR^0.33), or history of severe QTc interval prolongation;
- Laboratory test values during the screening period show the following abnormalities:
- Aspartate aminotransferase (AST) > 3× upper limit of normal (ULN), alanine aminotransferase (ALT) > 3× ULN, total bilirubin > 1.5× ULN (unless due to Gilbert's syndrome);
- Platelet count <50,000/μL (or <50 × 10^9/L), hemoglobin <9 g/dL (or <90 g/L), white blood cells <2.0 × 10^3/μL, absolute neutrophil count <1.0 × 10^3/μL;
- Creatinine clearance (CLcr) <60 mL/min (calculated using the Cockcroft-Gault formula: [140 - age (years)] × [weight (kg)] × (0.85, if female) / [72 × serum creatinine (mg/dL)]) or undergoing dialysis during screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- RTX treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RTX treatmentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| RTX treatment group | Other | 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. Receives: Drug: RTX treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: baseline, week 48 after treatment.
Secondary outcomes (9)
Annualized Relapse Rate (ARR)
ARR is lower, the better.
Measured: 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.
Measured: 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 )
Measured: 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.
Measured: 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 )
Measured: 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)
Measured: 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)
Measured: 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
Measured: baseline, week 48 after treatment
Adverse events
Adverse events during use of RTX
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-Vimentin Antibody-associated DiseasesStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051070
- Sponsor's protocol ID
- 2025XW-VIMA
- Status last verified
- Jun 2025
- First submitted
- 16 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Rituximab in the Treatment of Anti-Vimentin Antibody-associated Diseases
- ClinicalTrials.gov ID
- NCT07051070
- Acronym / sponsor ID
- 2025XW-VIMA
- Conditions
- Anti-Vimentin Antibody-associated Diseases, Meningoencephalomyelitis Associated With Vimentin IgG Autoantibodies
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RTX treatment group | Other | Drug: RTX treatmentThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years, no gender restrictions;
- Patients with positive CSF anti-Vimentin antibodies（VIMA）, clinically consistent with the clinical features of VIMA-related diseases reported in JAMA Neurology 2024; 3. EDSS ≥ 3.5 points or evidence of disease activity as defined by the protocol within 1 year prior to screening.
- Evidence of disease activity as defined by the protocol: One of the following manifestations within 6 months of the screening period: 1. Enlargement of lesions on brain or spinal cord MRI T2 sequence; 2. △EDSS > 0; 3. At least two FS scores increase by 1 point or at least 1 FS increases by 2 points (excluding rectal/bladder and brain); 4. Symptoms lasting for more than 24 hours without fever and more than 30 days since the last episode. 4. Sign informed consent.
Key exclusion criteria (18 listed)
- Allergy to the study drug;
- Known active infections during the screening period (excluding nail bed fungal infections or dental caries);
- Underwent any surgical procedure within 4 weeks prior to screening, has evidence of other demyelinating diseases or progressive multifocal leukoencephalopathy (PML);
- Positive serology for HIV or syphilis treponema or RPR during the screening period (if syphilis antibodies are negative, further serological testing for syphilis is not required);
- Chronic hepatitis B virus or hepatitis C virus infection that meets the following criteria: • HBsAg positive; • If HBsAg negative, HbcAb positive, further HBV DNA testing (result ≥1000 IU/mL); • If HCV antibody testing is positive, further HCV RNA testing (result above the upper limit of normal range at the research site);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RTX treatmentThis 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. | Drug | RTX treatment group |
Primary outcome
Change in Expanded Disability Status Scale (EDSS) score from baseline
Time frame: baseline, week 48 after treatment.
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)
9 secondary outcomes
Annualized Relapse Rate (ARR)
Time frame: Week 48 after treatment
The event of confirmed disability progression (CDP)
Time frame: Week 48 after treatment
Change in modified Rankin Scale (mRS) score from baseline
Time frame: baseline, week 48 after treatment
Change in time taken to complete the Timed 25-Foot Walk (T25FW) from baseline
Time frame: baseline, week 48 after treatment
Change in EQ-5D-5L scores from baseline
Time frame: baseline, week 48 after treatment
Changes in scale for the assessment and rating of ataxia (SARA) from baseline
Time frame: baseline, week 48 after treatment
Change in Scores of International Cooperative Ataxia Rating Scale (ICARS) from baseline
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
Time frame: baseline, week 48 after treatment
Adverse events
Time frame: through study completion, an average of 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing RTX treatment in people with Anti-Vimentin Antibody-associated Diseases and Meningoencephalomyelitis Associated With Vimentin IgG Autoantibodies, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun wei Hao, MD (01083198277, haojunwei@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Expanded Disability Status Scale (EDSS) score from baseline (time frame: baseline, week 48 after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.