Actively Recruiting
A Registry Study on Monoclonal Antibody-Based Therapies for Aquaporin-4 Antibody-Positive Neuromyelitis Optica Spectrum Disorders
Led by Tongji Hospital · Updated on 2025-09-08
200
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of different monoclonal antibody treatments for people in China who have aquaporin-4 immunoglobulin G-seropositive neuromyelitis optica spectrum disorders (AQP4-positive NMOSD). This study focuses on real-world use of these therapies and also aims to track changes in brain imaging and immune system markers before and after treatment. Participants will receive one of several treatments including Inebilizumab, Satralizumab, Eculizumab, Ofatumumab, Rituximab, or conventional immunosuppressive agents. Each participant has confirmed AQP4-positive NMOSD and has agreed to receive one of these monoclonal antibody-based therapies or conventional treatments. During the study, participants will be monitored for up to 96 weeks. Researchers will measure outcomes such as time to first relapse, relapse rates, and disability scores. They will also track new brain lesions on scans and levels of AQP4 antibodies in blood and spinal fluid. Safety and clinical stability will be regularly assessed throughout the trial.
CONDITIONS
Brief Title
Monoclonal Antibody-Based Therapies for AQP4-Positive NMOSD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must understand the study and provide written informed consent.
- Adults aged 18 to 65 years at the time of consent.
- Females of childbearing potential and males must use effective contraception during the study and for at least 30 days after final treatment.
- Confirmed diagnosis of aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder according to 2015 criteria.
- Clinical stability within 30 days before the baseline visit.
You will not qualify if you...
- Significant medical history of major systemic conditions that may affect safety.
- Prior stroke resulting in a modified Rankin Scale score greater than 3.
- Allergy to study treatments or their ingredients.
- History or current infection with HIV.
- Active hepatitis C infection; anti-HCV positive but undetectable RNA is allowed.
- Active hepatitis B infection; prior infection or vaccination immunity is allowed.
- Recent severe or recurrent infections within 90 days before baseline.
- History of active or latent tuberculosis.
- Active bacterial, fungal, or viral infections within 28 days before baseline.
- Contraindications to rescue therapies like rituximab, IVIG, corticosteroids, or cyclophosphamide.
- Previous exposure to certain immune therapies or stem cell transplant.
- Significant suicidal thoughts or behavior within the past year.
- Inability or unwillingness to follow study procedures.
- Severe sensory impairments or conditions preventing neuropsychological tests or MRI.
- Other conditions judged by investigators to affect eligibility or study integrity.
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 - Up to 96 weeks
Participants are observed over time to track their condition and response to monoclonal antibody therapies or conventional treatments.
Regular visits as per routine clinical care
Trial Site Locations
Total: 1 location
1
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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