Ofatumumab in AQP4-IgG Seropositive NMOSD
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.
| Condition(s) | Neuromyelitis Optica Spectrum Disorder |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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 ≥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. Exclusion Criteria: * Progressive neurological deterioration unrelated to rela |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Tang-Du Hospital |
| Locations | Xi'an, Shaanxi, China |
| Start date | 2022-06-28 |
| NCT ID | NCT05504694 |
| Official listing | https://clinicaltrials.gov/study/NCT05504694 |