psoriasis
Conditions
Interventions
Patients will be randomised 1:1 to adalimumab (per label) with concomitant MTX
10 mg/week and folic acid 5 mg/week (combination therapy group) or adalimumab
per label (monotherapy group).
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria:;*Have a diagnosis of moderate to severe plaque psoriasis (PASI*8 at time of screening); *Is a candidate for the treatment with biologic drugs according to the pertaining guidelines (NVDV 2011); *Willing and able to use adequate contraceptives during the study (all men and pre-menopausal women); *Adalimumab therapy will be started for the treatment of psoriasis *Signed informed consent.
Exclusion criteria
Exclusion criteria: *History of significant MTX or adalimumab toxicity, intolerability or contraindication *Prior treatment with adalimumab *Age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *The drug survival at one year. (drug survival by efficacy and drug survival by adverse events) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Efficacy expressed as the proportion of patients achieving PASI 75 and 90 at week 13, 25, 37, 49, 61, 73, 85, 97, 109, 121, 133 en 145 and reduction of absolute PASI at these timepoints; *Change in PGA (patient global assessment) and IGA (investigator global assessment); *Average adalimumab serum trough concentrations and ADA titers; *Change in impact on Quality of life (Skindex 29 and DLQI); *Occurrence of (serious) adverse events; *Patient characteristics (age, gender, ethnicity, BMI, PsA, smoking, alcohol use, disease duration, disease severity by PASI, concomitant medication, naïve for biologics versus non-naïve (perhaps specified per biologic), trial medication and potential other co-variates (e.g. genetic polymorphisms). | — |
Countries
Netherlands
Outcome results
None listed