Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06448715
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-04
Brief Title:
Real-World Treatment Study of Soliris Eculizumab
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
Real-World Treatment Study of Soliris Eculizumab
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SolirisPMS
Brief Summary:
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
This study will provide information on the population of Korean patients who are treated with Soliris
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None