This study is aimed to observe the effectiveness and safety of inebilizumab in the acute phase of neuromyelitis optica spectrum disorders.
This is a a multicentric, prospective, real word study of inebilizumab in NMOSD acute attack compared with oral immunosuppressant. A total of 50 patients will be enrolled at approximately 10 centers around China.
Study Type
OBSERVATIONAL
Enrollment
50
Inebilizumab: 300mg IV on Day1 and Day 15. The first dose of inelizumab is given during IVMP.
Oral immunosuppressants (azathioprine or mycolate mofetil) are initiated during IVMP.
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGChange in Expanded Disability Status Scale (EDSS) score from baseline
Change in Expanded Disability Status Scale (EDSS) score from baseline at the last visit(EDSS : Minimum Score 1, Maximum score 10, higher scores mean a worse outcome).
Time frame: 6 months
Change in Expanded Disability Status Scale (EDSS) score from baseline
Change in Expanded Disability Status Scale (EDSS) score from baseline at month 1, month 3(EDSS : Minimum Score 1, Maximum score 10, higher scores mean a worse outcome).
Time frame: 1 months, 3 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).
Time frame: 6 months
Change in modified Rankin score (mRS) from baseline
Change in modified Rankin score (mRS) from baseline at month 1, month 3, month 6(mRS : Minimum Score 0, Maximum score 6, higher scores mean a worse outcome).
Time frame: 1 months, 3 months, 6 months
Time to first relapse
Time frame: 6 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
Time frame: 6 months
Change in Timed 25 Foot Walk Test from baseline
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Change in time taken to complete the timed 25 foot walk test from baseline
Time frame: 1 months, 3 months , 6 months
Number of NMOSD attacked related rescue treatment
Time frame: 6 months
Change in serum GFAP levels from baseline
Change in serum GFAP levels from baseline at the last visit
Time frame: 6 months
Change in AQP4-ab titers from baseline
Change in AQP4-ab titers from baseline at the last visit
Time frame: 6 months
Change in Low-contrast Visual Acuity (LCVA) from baseline
Change in Low-contrast Visual Acuity (LCVA) at month 3, month 6)(The LCVA test is used to determine the number of letters that can be read on a standardized low-contrast Landolt C Broken Rings Chart held at a distance of 3 meters).
Time frame: 3 months, 6 months
Changes in EQ-5D-5L scores from baseline
Changes in EQ-5D scores from baseline at month 1 month, month 3 , month 6(EQ-5D-5L: Minimum Score 5, Maximum score 25, lower scores mean a better quality of life).
Time frame: 1 month, 3 months ,6 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 1, month 3,month 6.
Time frame: 3 months ,6 months