Patients with moderate to severe chronic plaque type psoriasis (Psoriasis Area and Severity Index (PASI > 10) and/or Body Surface Area (BSA) > 10) who failed or have contraindications and/or are intolerant to ultraviolet therapy, methotrexate or cyclosporin. MedDRA version: 9.1 Level: LLT Classification code 10050577 Term: Psoriatic plaque
Conditions
Interventions
Trade Name: Remicade
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Infliximab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: Enb
Sponsors
Academic Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adults patients (18-75 years of age) - Psoriasis Area and Severity Index (PASI > 10) and/or Body Surface Area (BSA) > 10. - Failed, contraindicated and/or intolerant to UV therapy, methotrexate or cyclosporin. - Informed consent - Able to complete Dutch questionnaires. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Pregnancy and lactation - Active (or chronic) infections including Hepatitis B and C viral infections, HIV and tuberculosis - Malignancy in last 10 years, except BCC and cervical in situ cancer - Demyelinating disease - Congestive heart failure (NYHA grade III or IV) - Allergic and hypersensitivity reactions to study drugs or ingredients - Any live virus or bacterial vaccination within 3 months - Severe liverfunction disorders >2 times and/or kidneyfunction disorders >1,5 times upper limits of the parameters.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To compare clinical efficacy of etanercept and infliximab (ie, proportion of patients achieving PASI75, I-GA almost clear, clear). 2. To compare patient reported outcomes such as HRQOL, PAGA and treatment satisfaction between etanercept and infliximab. 3. To compare from a societal perspective the incremental cost effectiveness ratio of the use of etanercept versus infliximab ;Secondary Objective: 1. In (good-)responders, to compare the duration of remission. 2. In non-responders, to investigate patients perspectives of the comparative drug. 3. To compare the side-effects. 4. Subgroup analyses in relation to (cost-) effectiveness and safety, and presence of neutralising antibodies. 5. To compare the improvement of nailpsoriasis graded by the NAPSI.;Primary end point(s): Clinical efficacy and patient reported outcomes: -PASI75 at week 12 and 24. -I-GA of clinical psoriasis severity of minimal or clear. -Improvement of HRQOL: median changes in the three domain scores of the dermatology specific Skindex-17, the scores physical and mental component scale of the generic SF-36 and PAGA. -Treatment satisfaction will be measured with median changes Treatment Medication Satisfaction Questionnaire (TMSQ) score. Economic evaluation: -The difference between the cost effectiveness of the two treatment options will be assessed. - The incremental cost effectiveness ratio (ICER) of infliximab relative to etanercept will be calculated and estimated in terms of costs per QALY. -Utilities will be assessed by using the EQ-5D. - Nonmedical costs (travel, productivity losses) and medical cost outside the hospital will be assessing using the indirect medical costs questionnaire, and the Labor and Health Questionnaire. | — |
Countries
Netherlands
Outcome results
None listed