Actively Recruiting
Monoclonal Antibody-Based Therapies for AQP4-Positive NMOSD
Led by Tongji Hospital · Updated on 2025-09-08
200
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this registry study is to evaluate the therapeutic efficacy and safety profiles of distinct monoclonal antibody-based therapies for aquaporin-4 immunoglobulin G-seropositive neuromyelitis optica spectrum disorders within the Chinese population under real-world clinical conditions. Secondary objectives include quantitative assessment of longitudinal neuroimaging biomarker variations and immunological profile alterations in longitudinal biological specimens pre- and post-therapeutic intervention.
CONDITIONS
Official Title
Monoclonal Antibody-Based Therapies for AQP4-Positive NMOSD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand study objectives and provide written informed consent
- Age between 18 and 65 years inclusive at consent
- Use of effective contraception during study and for 30 days after last treatment
- Confirmed diagnosis of AQP4-IgG-seropositive neuromyelitis optica spectrum disorder
- Clinical stability within 30 days before baseline visit
You will not qualify if you...
- Significant medical history of major systemic conditions affecting safety
- Prior cerebrovascular events with severe disability (mRS >3)
- Hypersensitivity to investigational therapy or its components
- History or positive test for HIV infection
- Active hepatitis C infection with detectable RNA
- Active hepatitis B infection with positive surface antigen or core antibody
- Recent chronic, recurrent, or severe 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
- Prior lymphoid irradiation, cladribine, T-cell vaccines, total body irradiation, or stem cell transplantation
- Suicidal ideation or behavior within past 12 months
- Inability or unwillingness to comply with study procedures
- Severe sensory impairments or conditions preventing neuropsychological or MRI assessments
- Any condition compromising eligibility or study integrity as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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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