๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* 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 โฅ18 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 (โค10mg 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.
Exclusion Criteria:
* 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.