Status:
TERMINATED
Dose Tapering Study of Adalimumab in Psoriasis
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
KU Leuven
University Ghent
Conditions:
Psoriasis Vulgaris
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The optimal therapeutic serum trough level (Ctrough) of adalimumab was defined between 3,5 and 7,0 µg/ml in patients with plaque type psoriasis. An adalimumab Ctrough above this therapeutic range did ...
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, ...
Eligibility Criteria
Inclusion
- Participants must have a clinical or histological diagnosis of chronic plaque-type psoriasis for at least 6 months prior to inclusion
- Participants must have a stable disease during maintenance on adalimumab (absolute PASI \< 3)
- Participants are not allowed to use topical steroids from 7 days before randomization until the end of the study (week 48).
- Participants must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
Exclusion
- Participants who have currently a predominant nonplaque form of psoriasis
- Participants who are pregnant, nursing or planning a pregnancy while enrolled in the study or within 12 weeks after receiving the last administration of study intervention
- Participants who are unable or unwilling to undergo multiple venapunctures
- Participants who are treated according to a different dosing schedule than standard dosing of adalimumab (regular dose regimen every 2 weeks; 40 mg)
Key Trial Info
Start Date :
February 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2022
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04028713
Start Date
February 16 2021
End Date
March 22 2022
Last Update
September 19 2024
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
AZ Maria Middelares
Ghent, East-Flanders, Belgium, 9000
2
AZ Sint-Lucas
Ghent, East-Flanders, Belgium, 9000
3
University Hospital Ghent
Ghent, East-Flanders, Belgium, 9000
4
Private practice Dermatology
Maldegem, East-Flanders, Belgium, 9990