Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04875299
Status:
UNKNOWN
Last Update Posted:
2021-08-25
First Post:
2021-04-29
Brief Title:
Optimal Adalimumab Plasma Concentrations in Ankylosing Spondylitis Patients
Sponsor:
The First Affiliated Hospital of Soochow University
Organization:
The First Affiliated Hospital of Soochow University
Study Overview
Official Title:
Evaluation of the Optimal Concentration Range of Adalimumab for Ankylosing Spondylitis in a Prospective Observational Study
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
NOT_YET_RECRUITING
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:
None
Brief Summary:
The optimal plasma concentration range of adalimumab in Chinese patients with active ankylosing spondylitis remains unknown the aims of this study is to determine the concentration-effect relationship and explore the effect of anti-drug antibody or biomarkers on clinical outcomes in a real-world setting
Detailed Description:
This prospective observational study will include Chinese adult patients with active ankylosing spondylitis receiving adalimumab treatment The primary outcome is the mean change from baseline in Ankylosing Spondylitis Disease Activity Score ASDAS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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