Monoclonal Antibody-Based Therapies for AQP4-Positive NMOSD
ConditionNMO Spectrum Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorTongji Hospital
About this trial
The primary objective of this registry study is to evaluate the therapeutic efficacy and safety profiles of distinct monoclonal antibody-based therapies for aquaporin-4 immunoglobulin G-seropositive neuromyelitis optica spectrum disorders within the Chinese population under real-world clinical conditions. Secondary objectives include quantitative assessment of longitudinal neuroimaging biomarker variations and immunological profile alterations in longitudinal biological specimens pre- and post-therapeutic intervention.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects must demonstrate capacity to comprehend the study's objectives and associated risks, provide written informed consent, and authorize utilization of confidential health information in compliance with national and regional data protection regulations.
Enrollment is permitted regardless of biological sex, with age ≥18 and ≤65 years (inclusive) at the time of informed consent provision.
All females of childbearing potential and biologically male participants must employ contraceptive measures meeting clinical trial standards throughout the study duration and for at least 30 days following the final administration of investigational therapy. Additionally, participants must abstain from gamete donation during the study period and for ≥30 days post-treatment cessation.
Confirmed diagnosis of aquaporin-4 immunoglobulin G (AQP4-IgG)-seropositive neuromyelitis optica spectrum disorders (NMOSD) per the 2015 International Consensus Diagnostic Criteria, with serological or cerebrospinal fluid verification of AQP4-IgG positivity for inclusion in the AQP4-NMOSD cohort. Participants must have provided documented consent for therapeutic intervention with one monoclonal antibody-based biologics.
Disqualifiers
Medical History and Current Health Status
Clinically significant medical history of cardiac, endocrine, hematologic, hepatic, immune, infectious, metabolic, renal, pulmonary, neurological, dermatologic, psychiatric, or other major systemic conditions that, in the investigator's judgment, would preclude safe trial participation.
Prior cerebrovascular events resulting in a baseline modified Rankin Scale (mRS) score >3.
Hypersensitivity to the investigational therapeutic agent(s) or their excipients.
Trial population
Confirmed diagnosis of aquaporin-4 immunoglobulin G (AQP4-IgG)-seropositive neuromyelitis optica spectrum disorders (NMOSD) per the 2015 International Consensus Diagnostic Criteria, with serological or cerebrospinal fluid verification of AQP4-IgG positivity for inclusion in the AQP4-NMOSD cohort.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Mab Therapy
DrugWhether receive mab therapy or not.
Treatment groups
200 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Inebilizumab treatment1 intervention
Group B: Satralizumab treatment1 intervention
Group C: Eculizumab treatment1 intervention
Group D: Ofatumumab treatment1 intervention
Group E: Rituximab treatment1 intervention
Group F: Conventional immunosuppressive agents treatment0 interventions
Trial outcomes
Primary outcomes
1
Time to first relapse
Time frame
Up to 96 weeks2
Median time to relapse
Time frame
Up to 96 weeks3
Annualized relapse rate
Time frame
Up to 96 weeks4
EDSS score
Time frame
Up to 96 weeksSecondary outcomes
1
Incidence of radiologically identified new gadolinium-enhancing lesions and/or new or enlarging T2-weighted lesions
Time frame
Up to 96 weeks2
AQP4-IgG titer in serum and cerebral spinal fluid
Time frame
Up to 96 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov