Clinical trial NCT06068829: Inebilizumab and Rituximab in Neuromyelitis Optica Spectrum Disorders
Official title: A Multicentric, Retrospective, Real-Word Study to Evaluate the Efficacy and Safety of Inebilizumab Compare With Rituximab in Neuromyelitis Optica Spectrum Disorders
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Neuromyelitis Optica Spectrum Disorders
Keywords: Neuromyelitis Optica Spectrum Disorders
Inebilizumab
Rituximab
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Neuromyelitis Optica Spectrum Disorders

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Expanded Disability Status Scale Score (EDSS) from baseline.
timeFrame: 12 months
measure: Time to first relapse
timeFrame: 12 months
measure: Number of new, and/or enlarging T2- hyperintense lesions detected by Magnetic Resonance Imaging (MRI)
timeFrame: 12 months
Secondary outcomes:
measure: Change in Expanded Disability Status Scale (EDSS) score from baseline
timeFrame: 6 months
measure: Percentage of Participants with Disability Improvement
timeFrame: 12 months
measure: Percentage of Participants with Disability Worsening
timeFrame: 12 months
measure: Change in modified Rankin score (mRS) from baseline
timeFrame: 12 months
measure: Change in Timed 25 Foot Walk Test from baseline
timeFrame: 12 months
measure: Number of NMOSD attacked related rescue treatment.
timeFrame: 12 months
measure: Annual relapse rate (ARR) before and after Inebilizumab/Rituximab
timeFrame: 12 months
measure: Change in serum glial fibrillary acidic protein antibody (GFAP-Ab) levels from baseline.
timeFrame: 12 months
measure: Change in aquaporin 4 antibody (AQP4-Ab) titers from baseline.
timeFrame: 12 months
measure: Change in serum Neurofilament light chain protein (NfL) levels from baseline.
timeFrame: 12 months
measure: Change in Visual Acuity (VA) from baseline
timeFrame: 12 months
measure: Changes in The Five Level of EuroQol Five Dimensions Questionnaire (EQ-5D-5L) scores from baseline
timeFrame: 12 months
measure: Change in retinal nerve fiber layer (RNFL) loss from baseline
timeFrame: 12 months
measure: Adverse reactions during treatment and follow-up
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Jinzhou Feng, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: