Psoriasis
Conditions
Interventions
Trade Name: Humira
Product Name: adalimumab
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: N/A
Other descriptive name: Humira
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with moderate to severe chronic plaque psoriasis who are currently being treated with adalimumab, etanercept or ustekinumab and have stable disease activity. • Absolute PASI score =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: • Patients with an absolute PASI score above 10 • Increase of DLQI score with > 50% from baseline • Age < 18 years • Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the minimal biologic drug serum trough concentration required to maintain stable disease activity in patients with moderate to severe chronic plaque psoriasis ;Secondary Objective: • To evaluate the potential cost reduction- of individualization of dose of biologic drugs compared to usual care treatment per label • To define the relationship between dosing interval, biologic drug serum trough concentration, the presence of ADA, and disease activity • To determine the patient characteristics and potential co-variates (such as co-medication, genetic polymorphism) that affect biologic drug serum trough concentrations and development of ADA ;Primary end point(s): The minimal biologic drug serum trough concentration required to maintain stable disease activity expressed in PASI score;Timepoint(s) of evaluation of this end point: 72 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Titers of ADA at biologic drug serum trough concentration • Occurrence of adverse events • Cost per patient within treatment period ;Timepoint(s) of evaluation of this end point: 72 weeks | — |
Countries
Netherlands
Outcome results
None listed