Patients with moderate-to-severe psoriasis. MedDRA version: 20.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Humira 40 mg oplossing voor injectie in voorgevulde spuit
Product Name: Adalimumab
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Num
Sponsors
Ghent University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants must be >18 years of age. 2. Participants must have a diagnosis of chronic plaque-type psoriasis for at least 6 months (with or without PsA), prior to inclusion. 3. Participant must remain on a highly effective method of birth control during the study or during the entire treatment with adalimumab (whether with is longer) 4. Participants must agree not to receive a live virus or live bacterial vaccination at least 3 months (or longer as indicated in the package insert of the relevant vaccine) prior to the first administration of study intervention (except for varicella and MMR vaccines), during the study, or within 3 months after the last administration of study intervention. 5. Participants must avoid prolonged sun exposure and use of tanning booths or other ultraviolet light sources during study . 6. 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: 1. Participants who have currently a predominant nonplaque forms of psoriasis (e.g. Erythrodermic, guttate, pustular) 2. Participants who are pregnant, nursing or planning a pregnancy or fathering a child while enrolled in the study or within 12 weeks after receiving the last administration of study intervention 3. Participants who have received, or are expected to receive, any live virus or bacterial vaccination (with the exception of varicella or MMR vaccines) within 3 months (or longer as indicated in the package insert of the relevant vaccine) prior to the first administration of study intervention, during the study, or within 12 weeks after the last administration of study intervention 4. Participants who have known allergies, hypersensitivity or intolerance to adalimumab or its excipients 5. Participants who are unable or unwilling to undergo multiple venapunctures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - The proportion of patients in each group in clinical remission (absolute PASI < 2) at year 1 after optimization (non-inferiority of intervention) - Optimization of extraction protocol for adalimumab serum trough levels and anti-drug antibodies (ADA) derived from micro-sampling technique. ;Secondary Objective: -The proportion of patients in each group who relapses [defined as the need for dose escalation (not in the standard based dosing arm)] -The proportion of patients in each group with serum trough levels (Ctrough) of adalimumab within the optimal interval -The proportion of patients in each group with anti-drug antibodies (ADA) against adalimumab (ADA positivity) -Evaluation of the cost-effectiveness of the intervention -Recording of demographic parameters during disease course monitored at baseline and at every visit (reflected by incidence, prevalence, mortality, standardized comorbidity incidence ratios and associations/risk factors) -Quality adjusted life years (QALY) -Determine inter- and intrapatient variability (IPV) -HRQoL EQ-5D-5L ;Primary end point(s): absolute PASI < 2 (clinical remission);Timepoint(s) of evaluation of this end point: over the course of 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): None;Timepoint(s) of evaluation of this end point: None | — |
Countries
Belgium
Contacts
Public ContactHIRUZ CTU
Ghent University Hospital
Outcome results
None listed