A Non-inferiority Study on Dose Reduction of Adalimumab in Psoriasis Patients Who Are Overtreated

PHASE4CompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

August 11, 2020

Primary Completion Date

March 22, 2022

Study Completion Date

August 22, 2022

Conditions
Psoriasis
Interventions
BIOLOGICAL

Dose tapering of adalimumab in patients with supratheurapeutic serum trough levels

In the dose tapering arm, adalimumab dosing frequency will be lowered to 40 mg every 3 weeks in patients who have supratherapeutic serum trough levels of adalimumab (33% reduction). If patients still have a good clinical response and supratherapeutic adalimumab serum trough levels, will be further tapered to a dose regimen of 1 subcutaneous injection (40mg) every 4 weeks (50% dose reduction).

PROCEDURE

Venapuncture

Blood samples will be collected to determine the serum trough levels and anti-drug antibodies of adalimumab

OTHER

Dermatology Life Quality Index (DLQI)

The impact of the disease on the patient will be assessed using the dermatology life quality index (DLQI).

OTHER

EQ-5D-5L questionnaire

The EQ-5D-5L which is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments will be assessed.

PROCEDURE

Dried blood spot sampling

A subset of patients will sample additionally by using dried blood sampling after the first drug injection post-inclusion.

Trial Locations (1)

9000

University Hospital, Ghent

All Listed Sponsors
collaborator

KU Leuven

OTHER

lead

University Hospital, Ghent

OTHER

NCT05683054 - A Non-inferiority Study on Dose Reduction of Adalimumab in Psoriasis Patients Who Are Overtreated | Biotech Hunter | Biotech Hunter