Actively Recruiting
Inebilizumab in Acute Neuromyelitis Optica Spectrum Disorders
Led by Xuanwu Hospital, Beijing · Updated on 2024-09-19
50
Participants Needed
1
Research Sites
55 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is aimed to observe the effectiveness and safety of inebilizumab in the acute phase of neuromyelitis optica spectrum disorders.
CONDITIONS
Official 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 by IPND
- Currently in the acute phase of NMOSD, with new or worsening 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 give 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
- Negative hepatitis B surface antigen and positive hepatitis B core antibody, or positive hepatitis B surface antigen carriers, or active tuberculosis or positive tuberculosis screening without appropriate treatment
- Other conditions judged by researchers as unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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