Real-World Treatment Study of Soliris (Eculizumab) (SolirisPMS)

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.

Study Overview

• Status: Completed
• Conditions: Observational

Detailed Description

The Korea Risk Management Plan (K-RMP) of Soliris Inj. 300mg (eculizumab, hereinafter referred to as 'Soliris' or study drug) includes Post-Marketing Surveillance (PMS) as part of the pharmacovigilance plan in accordance with 'Article 7-2 of Regulation on Pharmaceuticals Approval, Notification and Review'.

This study will be conducted to prepare data on drug use results required for post- marketing re-examination application of Soliris and the purpose of the study is to identify the safety under real world practice.

Soliris was approved by the Ministry of Food and Drug Safety on February 18, 2021 for the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP-4) antibody positive, and a 4 years of re-examination period was given based on the approval date of the indication and usage change.

The re-examination period for Soliris is calculated as February 17, 2025 in accordance with the 'Standards for Re-examination of New Drugs, etc.' This study includes about 11 adult patients with NMOSD positive for anti-aquaporin-4 (AQP-4) antibody currently treated with or initiating treatment with Soliris .

It will be conducted as a total surveillance method in which each subject who received the drug is recorded in the case report form during the study period. In addition, efforts will be made to conduct investigations on safety and efficacy, such as onset of side effect and expected effects, for all patients who received the product up to two years from the marketing date.

• Study Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• South Korea
  • Goyang-si, South Korea
    • Research Site
  • Seoul, South Korea
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

According to the medical judgment of the investigator, patients who received Soliris in accordance with product label will be enrolled if they meet all the inclusion criteria and none of the exclusion criteria.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety assessment of soliris	Safety (adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), serious ADRs (SADRs), unexpected AEs/ADRs)	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
efficacy assessment of Soliris	relapse of NMOSD	24 weeks

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2024
• Primary Completion (Actual): January 3, 2025
• Study Completion (Actual): January 3, 2025

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 7, 2024

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: D7412R00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No