Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05754710
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2023-02-22
Brief Title:
Korea Xeljanz Post-marketing Surveillance for Juvenile Idiopathic Arthritis
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
Korean Post-marketing Surveillance for Xeljanz 5 mg Film-coated Tablets and Xeljanz 1 mgmL Oral Solution in Patients With Active pJIA and jPsA
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
KRXeljanzJIA
Brief Summary:
This study is to assess the safety and effectiveness of Xeljanz in Juvenile Idiopathic Arthritis JIA patients in routine clinical practice in Korea JIA patients experience persistent joint pain swelling and stiffness This is a prospective observational study
Xeljanz is a JAK inhibitor It was first approved in 2014 for rheumatoid arthritis patients in Korea The ministry of Food and Drug Safety in Korea mandates for a drug manufacturer to report the post-marketing surveillance after drugs approval or indication extension This study is to see the safety and effectiveness of Xeljanz in Juvenile Idiopathic Arthritis patients in routine clinical practice in Korea
This study is seeking patients who
Are 2 to less than 18 years of age
Are given Xeljanz for the treatment of JIA
The study sponsor will monitor patients treatment experience for up to 44 weeks This will help assess the safety and effects of this study medicine
Xeljanz is a JAK inhibitor It was first approved in 2014 for rheumatoid arthritis patients in Korea The ministry of Food and Drug Safety in Korea mandates for a drug manufacturer to report the post-marketing surveillance after drugs approval or indication extension This study is to see the safety and effectiveness of Xeljanz in Juvenile Idiopathic Arthritis patients in routine clinical practice in Korea
This study is seeking patients who
Are 2 to less than 18 years of age
Are given Xeljanz for the treatment of JIA
The study sponsor will monitor patients treatment experience for up to 44 weeks This will help assess the safety and effects of this study medicine
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Xeljanz JIA PMS | OTHER | Alias Study Number | None |