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Neuromyelitis optica spectrum disorder (NMOSD) is a central nervous system autoimmune condition mainly involving the spinal cord, optic nerves, and area postrema. The anti-aquaporin-4 (AQP4)-Immunoglobulin G (IgG) is a specific biomarker for NMOSD. Glucocorticoids(GCs) are used as first-line treatment for NMOSD. Oral glucocorticoids tapering is always suggested following the pused therapy in the maintenance phase. Inebilizumab, a humanized monoclonal antibody targeting CD19, has been proven effective in preventing NMOSD relapses. This study aims to evaluate and compare the efficacy and differences between glucocorticoids slow-tapering and rapid-tapering strategies combined with inebilizumab in preventing relapses in AQP4-IgG-seropositive NMOSD patients following an acute attack, with the goal of determining the optimal approach to steroid tapering and discontinuation after initiation of inebilizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Slow-tapering glucocorticoids + Inebilizumab arm | Active Comparator |
| |
| Rapid-tapering glucocorticoids + Inebilizumab arm | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Slow-tapering glucocorticoids + Inebilizumab | Drug | Slow-tapering glucocorticoids+Inebilizumab arm: A 300 mg intravenous infusion of inebilizumab will be administered on Day 1 and Day 15, followed by 300 mg infusions every 26 weeks thereafter. Prednisone will be initiated at a daily dose of 60 mg as concomitant therapy with inebilizumab. The prednisone dose will be tapered as follows: a reduction of 5 mg every 2 weeks until reaching 20 mg/day(Week 16); thereafter, a reduction of 5 mg every 4 weeks until discontinuation (a total duration of 32 weeks for combined inebilizumab and glucocorticoids therapy). |
| Measure | Description | Time Frame |
|---|---|---|
| First adjudicated relapse event within 54 weeks | Baseline, 54 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Expanded Disability Status Scale (EDSS) score from baseline at 54 weeks | Baseline, 54 Weeks | |
| Change in Low-contrast Visual Acuity (LCVA) from baseline at 54 weeks | Baseline, 54 Weeks | |
| Measure | Description | Time Frame |
|---|---|---|
| Lymphocyte Subpopulation Monitoring at 54 weeks | Baseline, 54 Weeks | |
| Lymphocyte Subpopulation Monitoring at 106 weeks | Baseline, 106 Weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chun-Sheng Yang, M.D., Ph.D. | Contact | +86-022-60814587 | cyang01@tmu.edu.cn |
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| ID | Term |
|---|---|
| D009471 | Neuromyelitis Optica |
| ID | Term |
|---|---|
| D009188 | Myelitis, Transverse |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000609745 | inebilizumab |
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|
| Rapid-tapering glucocorticoids + Inebilizumab | Drug | Rapid-tapering glucocorticoids+Inebilizumab arm: A 300 mg intravenous infusion of inebilizumab will be administered on Day 1 and Day 15, followed by 300 mg infusions every 26 weeks thereafter. Prednisone will be initiated at a daily dose of 60 mg as concomitant therapy with inebilizumab, with a tapering schedule of 5 mg reduction per week until discontinuation (a total duration of 12 weeks for combined inebilizumab and glucocorticoids therapy). |
|
| Change in Timed 25-Foot Walk (T25-FW) test from baseline at 54 weeks |
| Baseline, 54 Weeks |
| Change in Expanded Disability Status Scale (EDSS) score from baseline at 106 weeks | Baseline, 106 Weeks |
| Change in Low-contrast Visual Acuity (LCVA) from baseline at 106 weeks | Baseline, 106 Weeks |
| Change in Timed 25-Foot Walk (T25-FW) test from baseline at 106 weeks | Baseline, 106 Weeks |
| Change in serum Neurofilament Light chain (sNfL) levels at 54 weeks | Baseline, 54 Weeks |
| Change in serum Glial Fibrillary Acidic Protein (sGFAP) levels at 54 weeks | Baseline, 54 Weeks |
| Change in serum AQP4-IgG titer at 54 weeks | Baseline, 54 Weeks |
| Change in serum Neurofilament Light chain (sNfL) levels at 106 weeks | Baseline, 106 Weeks |
| Change in serum Glial Fibrillary Acidic Protein (sGFAP) levels at 106 weeks | Baseline, 106 Weeks |
| Change in serum AQP4-IgG titer at 106 weeks | Baseline, 106 Weeks |
| Change in Visual Analogue Scale (VAS) score from baseline at 54 weeks | Baseline, 54 Weeks |
| Change in Visual Analogue Scale (VAS) score from baseline at 106 weeks | Baseline, 106 Weeks |
| Change in Quality of Life (QoL) score from baseline at 54 weeks | Baseline, 54 Weeks |
| Change in Quality of Life (QoL) score from baseline at 106 weeks | Baseline, 106 Weeks |
| Proportion of Relapse-free Participants at 54 weeks | Baseline, 54 Weeks |
| Proportion of Relapse-free Participants at 106 weeks | Baseline, 106 Weeks |
| Percentage of patients in glucocorticoid-free remission between 54 and 106 weeks | 54 Weeks, 106 Weeks |
| Annualized Relapse Rate (ARR) at 54 weeks | Baseline, 54 Weeks |
| Annualized Relapse Rate (ARR) at 106 weeks | Baseline, 106 Weeks |
| Daily and acumulate dose of glucocorticoids at relapse before 54 weeks | Baseline, 54 Weeks |
| Adverse events (AEs) and Serious AEs (SAEs) at 54 weeks | Baseline, 54 Weeks |
| Immunoglobulin levels at 54 weeks | Baseline, 54 Weeks |
| Pelvic X-ray at 54 weeks | Baseline, 54 Weeks |
| Adverse events (AEs) and Serious AEs (SAEs) at 106 weeks | Baseline, 106 Weeks |
| Immunoglobulin levels at 106 weeks | Baseline, 106 Weeks |
| Pelvic X-ray at 106 weeks | Baseline, 106 Weeks |
| D009902 | Optic Neuritis |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D003711 | Demyelinating Diseases |
| D005128 | Eye Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |