Actively Recruiting
Ofatumumab in AQP4-IgG Seropositive NMOSD
Led by Tang-Du Hospital · Updated on 2026-01-30
5
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
Sponsors
T
Tang-Du Hospital
Lead Sponsor
H
Henan Provincial People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open-label, single-arm, multicentre prospective pilot study to assess the efficacy and safety of ofatumumab in patients with AQP4-IgG seropositive neuromyelitis optica spectrum disorder (NMOSD) in China.
CONDITIONS
Official Title
Ofatumumab in AQP4-IgG Seropositive NMOSD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of NMOSD according to the 2015 International Panel Diagnostic Criteria for NMOSD with AQP4-IgG.
- Clinical evidence of at least 2 relapses (including first attack) in past 24 months with at least 1 relapse occurring in the preceding 12 months.
- Adults aged 6518 years old.
- Expanded disability status scale (EDSS) score between 0 and 7.5 (inclusive).
- Provision of written informed consent to participate in this study.
- Only oral corticosteroids were permitted at screening (6410mg equivalent per day), which should be terminated within one month.
- Effective contraception was used for female patients with fertility during the treatment or at least 3 months after stopping medication.
You will not qualify if you...
- Progressive neurological deterioration unrelated to relapses of NMOSD, or presence of neurological findings suspected with PML.
- Pregnant or breastfeeding patients and those with family planning during the study period.
- Patients participating in any other clinical therapeutic study at the screening or within 30 days of screening.
- Patients with splenectomy or history of no spleen, and those with planned surgery (excluding minor surgery) during the study period.
- Presence of uncontrolled severe concurrent diseases; long-term glucocorticoids or immunosuppressants use due to other autoimmune diseases, or presence of other chronic diseases that cannot receiving immunosuppression.
- Active infection at within 4 weeks before baseline.
- Positive for HBV or HCV.
- Evidence of latent or active tuberculosis (TB).
- Have received any live or live-attenuated vaccine within 6 weeks before baseline.
- History of malignancy in past 5 years, including solid tumor, malignant hematopathy and carcinoma in situ.
- History of severe allergic reactions to biological agents.
- Inability to provide written informed consent.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tangdu Hospital
Xi'an, Shaanxi, China
Actively Recruiting
Research Team
J
Jun Guo, M.D.
CONTACT
Y
Yan Jia, M.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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