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Real-World Treatment Study of Soliris (Eculizumab)

CompletedN/A

Sponsor: AstraZeneca

Conditions: Observational

Countries: South Korea

As part of a post-approval commitment, the Korean health authority requests a study to characterize safety and effectiveness in patients who are treated with Soliris in normal clinical practice settings. This study is designed to assess the known safety profile or identify previously unsuspected adverse reactions and to evaluate the effectiveness of Soliris under conditions of routine daily medical practice in Korea. This study will provide information on the population of Korean patients who are treated with Soliris.

Eligibility overview

Sex: ALL

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

1. Patients aged 19 or older with NMOSD positive for anti-aquaporin-4 (AQP-4) antibody who are receiving or starting treatment with Soliris according to the product label
2. Patients who have been vaccinated against Neisseria meningitidis at least 2 weeks prior to receiving the first dose of Soliris. However, patients who receive Soliris within 2 weeks after Neisseria meningitidis vaccination should receive treatment with appropriate prophylactic antibiotics for 2 weeks after vaccination
3. Patient who understood and consented to the written informed consent provided.

Exclusion Criteria:

1. Patients with hypersensitivity to eculizumab, murine protein, or any other component of Soliris
2. Patients with untreated serious Neisseria meningitidis infection.

Locations (2)

Goyang-si, South Korea
Seoul, South Korea