Ofatumumab in AQP4-IgG Seropositive NMOSD
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTang-Du Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Ofatumumab
Treatment groups
5 Participants
are divided into 1 treatment groupSponsors and collaborators
Tang-Du Hospital
Lead sponsor
Henan Provincial People's Hospital
Collaborator
Source ClinicalTrials.gov