Real-World Treatment Study of Soliris (Eculizumab)
- Conditions
- Observational
- Registration Number
- NCT06448715
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 11
Inclusion Criteria:<br><br> 1. Patients aged 19 or older with NMOSD positive for anti-aquaporin-4 (AQP-4) antibody<br> who are receiving or starting treatment with Soliris according to the product label<br><br> 2. Patients who have been vaccinated against Neisseria meningitidis at least 2 weeks<br> prior to receiving the first dose of Soliris. However, patients who receive Soliris<br> within 2 weeks after Neisseria meningitidis vaccination should receive treatment<br> with appropriate prophylactic antibiotics for 2 weeks after vaccination<br><br> 3. Patient who understood and consented to the written informed consent provided.<br><br>Exclusion Criteria:<br><br> 1. Patients with hypersensitivity to eculizumab, murine protein, or any other component<br> of Soliris<br><br> 2. Patients with untreated serious Neisseria meningitidis infection.
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety assessment of soliris
- Secondary Outcome Measures
Name Time Method efficacy assessment of Soliris