AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Ofatumumab in AQP4-IgG Seropositive NMOSD

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllTang-Du Hospital
๐Ÿ’ฌ

In 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.

๐Ÿ“‹ 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 โ‰ฅ18 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 (โ‰ค10mg 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.
๐Ÿ’Š

What it tests

  • Ofatumumab
๐Ÿ“

Where

1 site
Tangdu Hospital
Xi'an, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy