Ignite Creation Date:
2024-05-06 @ 1:26 PM
Last Modification Date:
2024-10-26 @ 1:14 PM
Study NCT ID:
NCT04028713
Status:
TERMINATED
Last Update Posted:
2022-12-21
First Post:
2019-07-19
Brief Title:
Dose Tapering Study of Adalimumab in Psoriasis
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
A Non-inferiority Study on Dose Reduction of Adalimumab in Psoriasis Patients
Status:
TERMINATED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Too slow inclusion rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The optimal therapeutic serum trough level Ctrough of adalimumab was defined between 35 and 70 µgml in patients with plaque type psoriasis An adalimumab Ctrough above this therapeutic range did not add clinical response Based on this therapeutic window the introduction of dose adjustments based on Ctroughs therapeutic drug monitoring will be further validated in a prospective randomized-controlled trial Here we aim to determine whether in patients with a good clinical response and supratherapeutic adalimumab Ctroughs dose reduction is able to maintain favorable clinical outcome
Detailed Description:
Patients will be included after signing informed consent and randomized in either a standard dose arm or a concentration based arm based on prior Ctrough measurements In the concentration based arm dosing frequency will be lowered to once every 3 weeks If patients still have supratherapeutic Ctroughs of adalimumab these patients will continue adalimumab self-administration every 4 weeks In the standard based arm patients will continue on standard dosing schedule During each study visit blood will be taken in order to quantify Ctroughs In addition Psoriasis Area and Severity Index PASI and Investigators Global Assessment IGA score will be evaluated by a physician Patients complete the Dermatology Life Quality Index DLQI and European quality of life EQ-5D instrument at each visit In addition in a subset of patients in each treatment arm additional sampling will be collected by dried blood spot sampling in order to build a PKPD model for adalimumab
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?:
None
Is an FDA AA801 Violation?:
None