Neuromyelitis Optica Spectrum DisordersNCT06068829
Inebilizumab and Rituximab in Neuromyelitis Optica Spectrum Disorders
An observational study of Neuromyelitis Optica Spectrum Disorders, run by Feng Jinzhou.
Trial summary
To compare the safety and efficacy of Inebilizumab and Rituximab in neuromyelitis optica spectrum disorders (NMOSD) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromyelitis Optica Spectrum Disorders
- What is being tested?
- Inebilizumab and Rituximab(RTX)
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2023to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients with Neuromyelitis Optica Spectrum Disorders
Who may be able to join
- 1. Age ≥ 18 years with anti-AQP4-IgG seropositive NMOSD as defined by 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis).
- 2. Expanded disability status scale (EDSS) score ≤ 8 and ≥ 2.5 during the acute phase.
- 3. Patients have given their written informed consent.
Who cannot join
- 1. Lactating and pregnant females.
- 2. Participate in other interventional studies within 30 days or within 5 half-lives of the investigational agent before received inebilizumab and rituximab (RTX).
- 3. Receipt of any experimental B-cell depleting agent within 6 months prior inebilizumab and RTX, and B-cells below the lower limit of normal
- 4. Known history of a severe allergy or reaction to any component of the investigational product formulation.
- 5. Known active severe bacterial, viral, or other infection or any major episode of infection requiring hospitalization (including viral hepatitis, active tuberculosis or positive tuberculosis screening).
- 6. History of alcohol, drug, or chemical abuse, or a recent history of such abuse < 1 year prior to treatment.
- 7. History of malignancies.
- 8. Combined with severe mental disorders and other conditions and unable to cooperate with follow-up.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicentric, Retrospective, Real-Word Study to Evaluate the Efficacy and Safety of Inebilizumab Compare With Rituximab in Neuromyelitis Optica Spectrum Disorders
To compare the safety and efficacy of Inebilizumab and Rituximab in neuromyelitis optica spectrum disorders (NMOSD) patients.
Read the detailed description
Inebilizumab is a humanized anti-CD19 monoclonal antibody. CD19 is broadly expressed on B-lineage cells, particularly late-stage memory B-lymphocytes and plasma blasts. Inebilizumab depletes antibody-secreting plasmablasts and some plasma cells.
Rituximab (RTX) is a chimeric anti-CD20 monoclonal antibody that promotes B-lymphocyte depletion through antibody-dependent cellular cytotoxicity (ADCC)/complement-dependent cytotoxicity (CDC), promotes an immunoregulatory T-lymphocyte phenotype, and activates neutrophil/macrophage phagocytosis.
This is a retrospective, multicentre, real-world study which aims to compare Inebilizumab with RTX in neuromyelitis optica spectrum disorders patients. Eighty patients from 8 centres in China will be enrolled.
- Conditions
- Neuromyelitis Optica Spectrum Disorders
- Being tested
- Inebilizumab, Rituximab(RTX)
- Keywords
- Neuromyelitis Optica Spectrum Disorders, Inebilizumab, Rituximab
- Medical subject headings
- Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InebilizumabDrug
Inebilizumab: 300mg IV on Day1 and Day 15. The first dose of inebilizumab was given after IVMP.
Rituximab(RTX)Drug
RTX: 500mg IV on Day 1 and Day15. The first dose of RTX was given after IVMP.
| Study group | Role | What they receive |
|---|---|---|
| Exposed group 1 | Intravenous methylprednisolone (IVMP) plus Inebilizumab Receives: Drug: Inebilizumab | |
| Exposed group 2 | IVMP plus Rituximab (RTX) Receives: Drug: Rituximab(RTX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Expanded Disability Status Scale Score (EDSS) from baseline.
Change in Expanded Disability Status Scale (EDSS) score from baseline to 12 months after treatment (EDSS: Minimum Score 1, Maximum score 10, higher scores mean a worse outcome).
Measured: 12 months
Time to first relapse
Relapse: A monophasic clinical episode with patient-reported symptoms and objective findings reflecting a focal or multifocal inflammatory demyelinating event in the central nervous system (CNS), developing acutely or subacutely, with a duration of at least 24h, without fever or infection.
Measured: 12 months
Number of new, and/or enlarging T2- hyperintense lesions detected by Magnetic Resonance Imaging (MRI)
Number of new, and/or enlarging T2-hyperintense lesions detected by Magnetic Resonance Imaging (MRI) at the last visit.
Measured: 12 months
Secondary outcomes (14)
Change in Expanded Disability Status Scale (EDSS) score from baseline
Change in Expanded Disability Status Scale (EDSS) score from baseline at month 6 (EDSS: Minimum Score 1, Maximum score 10, higher scores mean a worse outcome).
Measured: 6 months
Percentage of Participants with Disability Improvement
Disability improvement is defined as a reduction in EDSS score of: A) >=1.0 from the baseline EDSS score when the baseline score was <=5.5 B) >= 0.5 when the baseline EDSS score > 5.5(EDSS: Minimum Score 1, Maximum score 10, higher scores mean a worse outcome).
Measured: 12 months
Percentage of Participants with Disability Worsening
A participant was considered to have a worsening in overall EDSS score of at least 2 if baseline EDSS score was 0, or at least 1 point if baseline EDSS score is 1 to 5, or at least 0.5 point if baseline EDSS score is 5.5 or more.
Measured: 12 months
Change in modified Rankin score (mRS) from baseline
Change in modified Rankin score (mRS) from baseline at month 12(mRS: Minimum Score 0, Maximum score 6, higher scores mean a worse outcome).
Measured: 12 months
Change in Timed 25 Foot Walk Test from baseline
Change in time taken to complete the timed 25foot walk test from baseline
Measured: 12 months
Number of NMOSD attacked related rescue treatment.
Measured: 12 months
Annual relapse rate (ARR) before and after Inebilizumab/Rituximab
ARR will be measured in the baseline (according to patients' history before inebilizumab/rituximab) and after 12 months of intervention.
Measured: 12 months
Change in serum glial fibrillary acidic protein antibody (GFAP-Ab) levels from baseline.
Change in serum GFAP-Ab levels from baseline at the last visit
Measured: 12 months
Change in aquaporin 4 antibody (AQP4-Ab) titers from baseline.
Change in AQP4-ab titers from baseline at the last visit.
Measured: 12 months
Change in serum Neurofilament light chain protein (NfL) levels from baseline.
Change in serum NfL levels from baseline at the last visit.
Measured: 12 months
Change in Visual Acuity (VA) from baseline
Change in Visual Acuity (VA) at month 12.
Measured: 12 months
Changes in The Five Level of EuroQol Five Dimensions Questionnaire (EQ-5D-5L) scores from baseline
Changes in EQ-5D scores from baseline at month 12(EQ-5D-5L: Minimum Score 5, Maximum score 25, lower scores mean a better quality of life).
Measured: 12 months
Change in retinal nerve fiber layer (RNFL) loss from baseline
Change in retinal nerve fiber layer (RNFL) loss measured by optical coherence tomography (OCT) from baseline at month 12.
Measured: 12 months
Adverse reactions during treatment and follow-up
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start20 Oct 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromyelitis Optica Spectrum DisordersStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Feng Jinzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Feng Jinzhou, First Affiliated Hospital of Chongqing Medical University
- Investigators
- Jinzhou Feng, Ph.D, Principal investigator, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068829
- Sponsor's protocol ID
- IRNMO-001
- Status last verified
- Sep 2023
- First submitted
- 29 Sep 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentric, Retrospective, Real-Word Study to Evaluate the Efficacy and Safety of Inebilizumab Compare With Rituximab in Neuromyelitis Optica Spectrum Disorders
- ClinicalTrials.gov ID
- NCT06068829
- Acronym / sponsor ID
- IRNMO-001
- Conditions
- Neuromyelitis Optica Spectrum Disorders
- Keywords
- Neuromyelitis Optica Spectrum Disorders, Inebilizumab, Rituximab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Feng JinzhouUniversity, hospital or other
- Study start
- 20 Oct 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 5 Oct 2023 (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.
To compare the safety and efficacy of Inebilizumab and Rituximab in neuromyelitis optica spectrum disorders (NMOSD) patients.
Detailed description
Inebilizumab is a humanized anti-CD19 monoclonal antibody. CD19 is broadly expressed on B-lineage cells, particularly late-stage memory B-lymphocytes and plasma blasts. Inebilizumab depletes antibody-secreting plasmablasts and some plasma cells.
Rituximab (RTX) is a chimeric anti-CD20 monoclonal antibody that promotes B-lymphocyte depletion through antibody-dependent cellular cytotoxicity (ADCC)/complement-dependent cytotoxicity (CDC), promotes an immunoregulatory T-lymphocyte phenotype, and activates neutrophil/macrophage phagocytosis.
This is a retrospective, multicentre, real-world study which aims to compare Inebilizumab with RTX in neuromyelitis optica spectrum disorders patients. Eighty patients from 8 centres in China will be enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed group 1 | – | Drug: InebilizumabIntravenous methylprednisolone (IVMP) plus Inebilizumab |
| Exposed group 2 | – | Drug: Rituximab(RTX)IVMP plus Rituximab (RTX) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Neuromyelitis Optica Spectrum Disorders
Key inclusion criteria (3 listed)
- 1. Age ≥ 18 years with anti-AQP4-IgG seropositive NMOSD as defined by 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis).
- 2. Expanded disability status scale (EDSS) score ≤ 8 and ≥ 2.5 during the acute phase.
- 3. Patients have given their written informed consent.
Key exclusion criteria (8 listed)
- 1. Lactating and pregnant females.
- 2. Participate in other interventional studies within 30 days or within 5 half-lives of the investigational agent before received inebilizumab and rituximab (RTX).
- 3. Receipt of any experimental B-cell depleting agent within 6 months prior inebilizumab and RTX, and B-cells below the lower limit of normal
- 4. Known history of a severe allergy or reaction to any component of the investigational product formulation.
- 5. Known active severe bacterial, viral, or other infection or any major episode of infection requiring hospitalization (including viral hepatitis, active tuberculosis or positive tuberculosis screening).
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 |
|---|---|---|
| InebilizumabInebilizumab: 300mg IV on Day1 and Day 15. The first dose of inebilizumab was given after IVMP. | Drug | Exposed group 1 |
| Rituximab(RTX)RTX: 500mg IV on Day 1 and Day15. The first dose of RTX was given after IVMP. | Drug | Exposed group 2 |
Primary outcome
Change in Expanded Disability Status Scale Score (EDSS) from baseline.
Time frame: 12 months
Change in Expanded Disability Status Scale (EDSS) score from baseline to 12 months after treatment (EDSS: Minimum Score 1, Maximum score 10, higher scores mean a worse outcome).
Time to first relapse
Time frame: 12 months
Relapse: A monophasic clinical episode with patient-reported symptoms and objective findings reflecting a focal or multifocal inflammatory demyelinating event in the central nervous system (CNS), developing acutely or subacutely, with a duration of at least 24h, without fever or infection.
Number of new, and/or enlarging T2- hyperintense lesions detected by Magnetic Resonance Imaging (MRI)
Time frame: 12 months
Number of new, and/or enlarging T2-hyperintense lesions detected by Magnetic Resonance Imaging (MRI) at the last visit.
14 secondary outcomes
Change in Expanded Disability Status Scale (EDSS) score from baseline
Time frame: 6 months
Percentage of Participants with Disability Improvement
Time frame: 12 months
Percentage of Participants with Disability Worsening
Time frame: 12 months
Change in modified Rankin score (mRS) from baseline
Time frame: 12 months
Change in Timed 25 Foot Walk Test from baseline
Time frame: 12 months
Number of NMOSD attacked related rescue treatment.
Time frame: 12 months
Annual relapse rate (ARR) before and after Inebilizumab/Rituximab
Time frame: 12 months
Change in serum glial fibrillary acidic protein antibody (GFAP-Ab) levels from baseline.
Time frame: 12 months
Change in aquaporin 4 antibody (AQP4-Ab) titers from baseline.
Time frame: 12 months
Change in serum Neurofilament light chain protein (NfL) levels from baseline.
Time frame: 12 months
Change in Visual Acuity (VA) from baseline
Time frame: 12 months
Changes in The Five Level of EuroQol Five Dimensions Questionnaire (EQ-5D-5L) scores from baseline
Time frame: 12 months
Change in retinal nerve fiber layer (RNFL) loss from baseline
Time frame: 12 months
Adverse reactions during treatment and follow-up
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
Related trials for Neuromyelitis Optica Spectrum Disorders
Not yet recruiting
Neurogenetics and Multi-omics of Neuroinflammatory Diseases in Multiplex Families to Improve Patients Health
Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorder
Recruiting
Impact of a Structured Wellness Behavioral Intervention on Quality of Life in NMOSD
Neuromyelitis Optica Spectrum Disorder (NMOSD)
RecruitingObservational study
Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
Neuromyelitis Optica Spectrum Disorder, Pregnancy Related
RecruitingPhase 2
Efgartigimod for the Treatment of Acute Optic Neuritis
Optic Neuritis
Active, not recruitingObservational study
Biobank For MS And Other Demyelinating Diseases
Multiple Sclerosis, Transverse Myelitis
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. This study is not recruiting at the moment.
Jinzhou Feng, Ph.D principal investigator
First Affiliated Hospital of Chongqing Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromyelitis Optica Spectrum Disorders, run by Feng Jinzhou.
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 8 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: status not confirmed, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinzhou Feng, Ph.D (023-89012487, 203756@cqmu.edu.cn), 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 Score (EDSS) from baseline. (time frame: 12 months). The study lists 3 primary outcomes in all. 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 5 Oct 2023.