Inebilizumab in Acute Neuromyelitis Optica Spectrum Disorders
- Conditions
- Neuromyelitis Optica Spectrum Disorder
- Interventions
- Drug: oral immunosuppressant
- Registration Number
- NCT05891379
- Lead Sponsor
- Xuanwu Hospital, Beijing
- Brief Summary
This study is aimed to observe the effectiveness and safety of inebilizumab in the acute phase of neuromyelitis optica spectrum disorders.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
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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; 6. Women of childbearing potential who agree to use adequate contraception during the study.
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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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Non-exposed group oral immunosuppressant IVMP plus oral immunosuppressant (Mycophenolate Mofetil or Azathioprine) Exposed group Inebilizumab intravenous Intravenous methylprednisolone (IVMP) plus intravenous inebilizumab
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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).
Change in serum GFAP levels from baseline 6 months Change in serum GFAP levels from baseline 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 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 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).
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 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.
Trial Locations
- Locations (1)
Xuanwu Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China