Ofatumumab in AQP4-IgG Seropositive NMOSD

Korábbi kezelés

• 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.

Más betegség

• 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.

Egyéb

• 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.

• 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.