Ignite Creation Date:
2024-05-06 @ 2:51 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02147600
Status:
COMPLETED
Last Update Posted:
2022-12-23
First Post:
2014-05-21
Brief Title:
Therapeutic Drug Monitoring of Adalimumab in Psoriasis Patients
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
Therapeutic Drug Monitoring of Adalimumab in Psoriasis Patients
Status:
COMPLETED
Status Verified Date:
2022-12
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:
None
Brief Summary:
The main goal of this study is to determine optimal cut-off values of adalimumab trough levels corresponding to good clinical response Determination of these values is necessary to compose a therapeutic algorithm in which the dosing schedule can be adjusted according to serum trough levels of adalimumab and AAA anti-adalimumab antibodies A secondary objective of this study is to further detect and quantify AAA and to correlate them with adalimumab and clinical response in a real life setting cohort of psoriatic patients
Detailed Description:
In a multicenter cross-sectional study 73 adult patients treated with adalimumab 40 mg every other week for at least 24 weeks are assessed for psoriasis disease severity through measurement of the Psoriasis Area and Severity Index PASI before adalimumab treatment start and prior to sampling Patients who interrupted their treatment schedule during the 24 weeks prior to blood sampling are excluded Samples of patients who were treated with adalimumab for any other inflammatory disease and later developed psoriasis are also excluded Percentage of PASI improvement compared to baseline PASI represents clinical response Patients are classified as nonresponders PASI50 moderate responders PASI 50-75 or good responders PASI 75-100Serum is collected for adalimumab trough level and anti-drug antibody determination Sanquin The Netherlands By receiver-operator characteristics ROC analysis a cut-off value of adalimumab trough level can be determined to distinguish insufficient from adequate responders
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
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