Neuromyelitis optica aquaporin-4 antibody positive
Conditions
Interventions
Experimental Group:Telitacicept, subcutaneous injection, once a week, for a total of 48 weeks
Sponsors
The First Affiliated Hospital of Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–65 years (inclusive); must sign a written informed consent form. 2. Must meet the 2015 international diagnostic criteria for NMOSD and have serum AQP4-IgG positivity (CBA method). 3. Core criterion – Poor response to or failure of RTX: At least one clinically confirmed relapse occurred within 12 months prior to screening, against a background of documented RTX treatment. o Note: "RTX treatment background" is defined as meeting any of the following conditions: (a) Resistance/breakthrough: Relapse occurring within 6 months of the last RTX infusion (regardless of CD19 levels). (b) Rapid relapse/incomplete eradication: Relapse occurring >6 months after the last RTX infusion, but accompanied by incomplete eradication or rapid recovery of CD19+ B cells (>1% or >10 cells/µL). 4. EDSS score of 0–6.5 at screening. 5. Female subjects of childbearing potential agree to use contraception during the study and for 6 months after the last dose.
Exclusion criteria
Exclusion criteria: 1.Diagnosed with MOGAD, multiple sclerosis (MS), or other autoimmune encephalitis. 2. Previous use of biologic agents targeting the BAFF/APRIL pathway (such as Telitacicept and belimumab). 3. Hypogammaglobulinemia: Screening period IgG < 4.0 g/L. o Note: If IgG is between 4.0-5.0 g/L and there is no history of severe/opportunistic infections, participants may be enrolled after the investigator assesses the benefit-risk ratio, but secondary safety monitoring must be initiated (see Section 11). 4. Severe active infections: o Hepatitis B (HBsAg positive or detectable HBV DNA), Hepatitis C (HCV RNA positive), HIV positive, Syphilis. o Latent tuberculosis infection screening (IGRA) positive and not completed standard prophylactic treatment. 5. Pregnant or lactating women. 6. Severe cardiac, hepatic, or renal dysfunction, or a history of malignant tumors within the past 5 years. 7. Allergic to reagents involved in the research institute. 8. Other situations deemed unsuitable by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 48-week recurrence-free rate;Diffusion Tensor Imaging,DTI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Annual recurrence rate,ARR; | — |
Countries
China
Contacts
Public ContactAiyu Lin
The First Affiliated Hospital of Fujian Medical University
Outcome results
None listed