Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04876781
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2021-04-20
Brief Title:
Korean Post-marketing Surveillance for Xeljanz XR
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
Korean Post-marketing Surveillance for Xeljanz XR Registered
Status:
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:
XRPMS
Brief Summary:
Xeljanz XR extended-release tablets 11 mg Tofacitinib citrate is a drug subject to the risk management plan in accordance with Article 4-1-11 of the Regulation on Safety of Medicinal Products etc in Korea As part of additional pharmacovigilance activity this Post-marketing Surveillance PMS was planned to evaluate safety and effectiveness of Xeljanz XR under routine clinical practice At least 200 patients with Rheumatoid Arthritis Psoriatic Arthritis or Ankylosing Spondylitis who were treated with Xeljanz XR will be enrolled about four years
Detailed Description:
This is a open-label non-comparative non-interventional prospective and multi-center study to further evaluate the safety and effectiveness of Xeljianz XR in routine clinical practice in Korea
Safety is the primary interest of this study which will be assessed based on adverse events AEs that occur during the 6 months from the first dose of Xeljanz XR The efficacy endpoints will be the modified Disease Activity Score using 28 joint counts DAS28 change from baseline European League Against Rheumatism EULAR response and American College of Rheumatology 20 improvement criteria ACR20 response after treatment
Safety is the primary interest of this study which will be assessed based on adverse events AEs that occur during the 6 months from the first dose of Xeljanz XR The efficacy endpoints will be the modified Disease Activity Score using 28 joint counts DAS28 change from baseline European League Against Rheumatism EULAR response and American College of Rheumatology 20 improvement criteria ACR20 response after treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None