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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposed group | intravenous Intravenous methylprednisolone (IVMP) plus intravenous inebilizumab |
| |
| Non-exposed group | IVMP plus oral immunosuppressant (Mycophenolate Mofetil or Azathioprine) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inebilizumab | Drug | Inebilizumab: 300mg IV on Day1 and Day 15. The first dose of inelizumab is given during IVMP. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change 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). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 1 months, 3 months |
| Percentage of Participants With Disability Improvement |
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Inclusion Criteria:
Exclusion Criteria:
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NMOSD patients with acute attacks
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junwei Hao, MD | Contact | 010-83198277 | haojunwei@vip.163.com |
| Name | Affiliation | Role |
|---|---|---|
| Junwei Hao, MD | Xuanwu Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100053 | China |
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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 |
| D007166 | Immunosuppressive Agents |
| ID | Term |
|---|---|
| D007155 | Immunologic Factors |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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Blood samples are collected before the treatment and at the last visit.
| oral immunosuppressant | Drug | Oral immunosuppressants (azathioprine or mycolate mofetil) are initiated during IVMP. |
|
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). |
| 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). | 1 months, 3 months, 6 months |
| Time to first relapse | 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 | 6 months |
| Change in Timed 25 Foot Walk Test from baseline | Change in time taken to complete the timed 25 foot walk test from baseline | 1 months, 3 months , 6 months |
| Number of NMOSD attacked related rescue treatment | 6 months |
| Change in serum GFAP levels from baseline | Change in serum GFAP levels from baseline at the last visit | 6 months |
| Change in AQP4-ab titers from baseline | Change in AQP4-ab titers from baseline at the last visit | 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). | 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). | 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. | 3 months ,6 months |
| D009902 | Optic Neuritis |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D003711 | Demyelinating Diseases |
| D005128 | Eye Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |