Ofatumumab in AQP4-IgG Seropositive NMOSD
Efficacy and Safety of Ofatumumab in AQP4-IgG Seropositive NMOSD: an Open-label, Single-arm, Multicentre Prospective Pilot Study
Tang-Du Hospital
5 participants
Jun 28, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria12
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
The enrolled patients will receive ofatumumab (20 mg/0.4 ml) subcutaneously administered at baseline, Day 7, Day 14 and monthly thereafter. Patients will receive ofatumumab therapy for a total of 48 weeks. The first 4 infusions will be administered at study center site; subsequent infusions will be given in the patient's home with a nurse online interview to administer the infusion.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05504694