This is a nationwide observational study looking at how ravulizumab, a complement C5 inhibitor, affects blood biomarkers o sNfL and sGFAP in people with AQP4-antibody positive NMOSD. The study does not change your treatment-only regular blood samples are collected to monitor these markers
Patient must be 18 years of age or older, at the time of signing the informed consent.
Anti-AQP4 Ab-positive at screening and a diagnosis of NMOSD as defined by the 2015 international consensus diagnostic criteria (Wingerchuk, 2015). A historically positive anti-AQP4 Ab test may be acceptable if the test was performed using an acceptable, validated cell-based assay from an accredited laboratory.
At least 1 clinical attack prior to the Prescreening/Screening Periods.
Treatment-naïve patients or patients under specific off-label treatments (rituximab, corticosteroids, azathioprine, mycophenolate mofetil) or the complement C5 inhibitor ravulizumab. Naïve patients who initiate ravulizumab at enrolment, should have been prescribed ravulizumab, but not yet initiated treatment, according to the label and local market reimbursement criteria.
History of N. meningitidis infection.
Human immunodeficiency virus (HIV) infection (evidenced by HIV-1 or HIV-2 antibody titer)
History of unexplained infections.
Active systemic bacterial, viral, or fungal infection within 14 days prior to screening.
The target population in the study will include diagnosed patients with AQP4-IgG seropositive NMOSD. Age ≥ 18 years with a history of ≥ 1 NMOSD clinical attack according to 2015 NMOSD criteria1. The participants should be undergoing treatment either with off-label ISTs (corticosteroids, azathioprine, mycophenolate mofetil, rituximab) or complement inhibitor therapy with ravulizumab. Corticosteroids can be used as add-on therapy to ravulizumab or the off-label ISTs.
Other
Prospective
Blood samples for sNfL and sGFAP levels
Diagnostic testBlood samples for sNfL and sGFAP levels
• Changes in sNfL and sGFAP levels during disease course in AQP4-IgG NMOSD seropositive patients receiving Ravulizumab
To evaluate sNfL and sGFAP levels and their fluctuations over time in AQP4-IgG seropositive NMOSD patients receiving complement inhibitor Ravulizumab
Correlation analysis of sGFAP and sNfL levels with the EDSS score.
To evaluate the association of sGFAP and sNfL levels with clinical disability.
Changes in sGFAP levels in patients experiencing relapse
To assess the clinical utility of sGFAP levels in AQP4-IgG seropositive NMOSD patients to predict clinical relapse risk.
Alterations in sNfL and sGFAP levels during disease course in AQP4-IgG NMOSD seropositive patients receiving receiving off-label ISTs
To investigate for alterations in sNfL and sGFAP levels over time in AQP4-IgG seropositive NMOSD patients receiving off-label ISTs
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This trial is not recruiting at the moment. You can still explore other options:
