Ofatumumab in AQP4-IgG Seropositive NMOSD

Ki vehet részt

• 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 ≥18 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 (≤10mg 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

Ki nem vehet részt

• 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
• Have received any live or live-attenuated vaccine within 6 weeks before baseline
• Patients with splenectomy or history of no spleen, and those with planned surgery (excluding minor surgery) during the study period
• Positive for HBV or HCV
• Evidence of latent or active tuberculosis (TB)
• History of malignancy in past 5 years, including solid tumor, malignant hematopathy and carcinoma in situ
• History of severe allergic reactions to biological agents
• 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
• Inability to provide written informed consent