Inebilizumab in Acute Neuromyelitis Optica Spectrum Disorders
Study Details
Study Description
Brief Summary
This study is aimed to observe the effectiveness and safety of inebilizumab in the acute phase of neuromyelitis optica spectrum disorders.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Exposed group intravenous Intravenous methylprednisolone (IVMP) plus intravenous inebilizumab |
Drug: Inebilizumab
Inebilizumab: 300mg IV on Day1 and Day 15. The first dose of inelizumab is given during IVMP.
|
| Non-exposed group IVMP plus oral immunosuppressant (Mycophenolate Mofetil or Azathioprine) |
Drug: oral immunosuppressant
Oral immunosuppressants (azathioprine or mycolate mofetil) are initiated during IVMP.
|
Outcome Measures
Primary Outcome Measures
- Change in Expanded Disability Status Scale (EDSS) score from baseline [6 months]
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).
Secondary Outcome Measures
- Change in Expanded Disability Status Scale (EDSS) score from baseline [1 months, 3 months]
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).
- Percentage of Participants With Disability Improvement [6 months]
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).
- Change in modified Rankin score (mRS) from baseline [1 months, 3 months, 6 months]
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 to first relapse [6 months]
- Number of New, and/or Enlarging T2 Hyperintense Lesions Detected by Magnetic Resonance Imaging (MRI) [6 months]
Number of New, and/or Enlarging T2 Hyperintense Lesions Detected by Magnetic Resonance Imaging (MRI) at the last visit
- Change in Timed 25 Foot Walk Test from baseline [1 months, 3 months , 6 months]
Change in time taken to complete the timed 25 foot walk test from baseline
- Number of NMOSD attacked related rescue treatment [6 months]
- Change in serum GFAP levels from baseline [6 months]
Change in serum GFAP levels from baseline at the last visit
- Change in AQP4-ab titers from baseline [6 months]
Change in AQP4-ab titers from baseline at the last visit
- Change in Low-contrast Visual Acuity (LCVA) from baseline [3 months, 6 months]
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).
- Changes in EQ-5D-5L scores from baseline [1 month, 3 months ,6 months]
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).
- Change in retinal nerve fiber layer (RNFL) loss from baseline [3 months ,6 months]
Change in retinal nerve fiber layer (RNFL) loss measured by optical coherence tomography (OCT) from baseline at month 1, month 3，month 6.
Eligibility Criteria
Criteria
Inclusion Criteria:
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- Age ≥ 18 years with anti-AQP4-IgG seropositive NMOSD as defined by 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis); 2. In the acute phase of NMOSD (definition of acute phase: new neurological symptoms or aggravation of existing symptoms within 30 days before screening, lasting at least 24 hours without with fever); 3. Patients who plan to receive or are receiving intravenous methylprednisolone therapy; 4. Expanded disability status scale (EDSS) score ≤ 8 and ≥ 2.5 during the screening period; 5. Able and willing to give written informed consent;
- Women of childbearing potential who agree to use adequate contraception during the study.
Exclusion Criteria:
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- Lactating and pregnant females; 2. Participate in other interventional studies within 30 days before screening or within 5 half-lives of the investigational agent before enrollment; 3. Combined with severe mental disorders and other conditions and unable to cooperate with follow-up; 4. History of malignancies; 5. Received plasma exchange, immunoadsorption or intravenous immunoglobulin therapy within 1 month before screening; 6. Patients with negative hepatitis B surface antibody (HBsAg) and positive hepatitis B core antibody (HBcAb), or HBsAg-positive virus carriers, or patients with active tuberculosis or positive tuberculosis screening without appropriate treatment history; 7. Other situations that researchers think are not suitable to participate in this study.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Xuanwu Hospital, Beijing
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Investigators
- Principal Investigator: Junwei Hao, MD, Xuanwu Hospital, Beijing
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- XMEC-2023-003