Actively Recruiting
Effectiveness and Safety of Inebilizumab in the Acute Phase of Neuromyelitis Optica Spectrum Disorders-a Multicentric, Prospective, Real Word Study
Led by Xuanwu Hospital, Beijing · Updated on 2024-09-19
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of inebilizumab in adults with neuromyelitis optica spectrum disorders (NMOSD) during the acute phase of the disease. This multicenter, prospective, real-world study compares inebilizumab combined with intravenous methylprednisolone to oral immunosuppressants plus intravenous methylprednisolone. Around 50 patients will participate across approximately 10 centers in China. Participants receive either intravenous methylprednisolone with inebilizumab (300mg given intravenously on Day 1 and Day 15 during methylprednisolone treatment) or intravenous methylprednisolone combined with oral immunosuppressants such as azathioprine or mycophenolate mofetil. The study focuses on treatments given during the acute attack phase of NMOSD. During the study, participants will be closely monitored for changes in disability using the Expanded Disability Status Scale (EDSS) over six months, as well as other assessments like the modified Rankin score, relapse timing, MRI imaging, visual acuity, and blood biomarkers. Safety and effectiveness measurements will occur at multiple time points, including 1, 3, and 6 months. The study aims to understand treatment impact on disease progression and recovery.
CONDITIONS
Brief Title
Inebilizumab in Acute Neuromyelitis Optica Spectrum Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older with anti-AQP4-IgG seropositive NMOSD as defined by 2015 diagnostic criteria
- In the acute phase of NMOSD with new or worsened neurological symptoms within 30 days before screening lasting at least 24 hours without fever
- Planning to receive or currently receiving intravenous methylprednisolone therapy
- Expanded Disability Status Scale (EDSS) score between 2.5 and 8 during screening
- Able and willing to provide written informed consent
- Women of childbearing potential agree to use adequate contraception during the study
You will not qualify if you...
- Pregnant or lactating females
- Participation in other interventional studies within 30 days before screening or within 5 half-lives of the investigational agent before enrollment
- Severe mental disorders or other conditions preventing cooperation with follow-up
- History of malignancies
- Received plasma exchange, immunoadsorption, or intravenous immunoglobulin therapy within 1 month before screening
- Positive hepatitis B surface antigen or certain hepatitis B antibody profiles without treatment, active tuberculosis or positive tuberculosis screening without appropriate treatment
- Other conditions deemed unsuitable for study participation by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 months
Participants receive intravenous methylprednisolone therapy combined with either intravenous inebilizumab or oral immunosuppressants during the acute phase of Neuromyelitis Optica Spectrum Disorders.
Visits at baseline, 1 month, 3 months, and 6 months for assessments
Trial Site Locations
Total: 1 location
1
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100053
Actively Recruiting
Research Team
J
Junwei Hao, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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