An independent prospective randomised controlled trial comparing the efficacy and cost effectiveness of infliximab and etanercept in 'high need' patients with moderate to severe chronic plaque type psoriasis
- Conditions
- chronic skin disease with increased keratinizationpsoriasis10011063
- Registration Number
- NL-OMON35488
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 120
- Adults patients (18-75 years of age)
- Psoriasis Area and Severity Index (PASI *10) and/or Body Surface Area (BSA) * 10, and/or PASI* 8 together with skindex * 35.
- Failed, contraindicated and/or intolerant to UV therapy, en methotrexate or cyclosporin.
- Informed consent
- Able to complete Dutch questionnaires.
- 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
- 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 kidney function disorders >1,5 times upper limits of the parameters.
-Treatment of infliximab or etanercept stopped because of inefficacy, contraindication or serious adverse events, after infliximab therapy for minimal 3 infusions and an evaluation after 12 weeks, or etanercept therapy for minimal 12 weeks
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Efficacy: - PASI75 and I-GA of clinical psoriasis severity of minimal or clear<br /><br>at week 12 and 24.<br /><br>-Improvement of HRQOL(Health related Quality of Life): median changes in the<br /><br>three domain scores of the dermatology specific Skindex-17, the generic SF-36<br /><br>and PAGA (patient global assessment).<br /><br>-Treatment satisfaction: median changes Treatment Medication Satisfaction<br /><br>Questionnaire (TMSQ) score.<br /><br>- The incremental cost effectiveness ratio (ICER) of infliximab relative to<br /><br>etanercept will be calculated and estimated in terms of costs per QALY (Quality<br /><br>Adjusted Life Year), by using the EQ-5D.<br /><br>- Nonmedical costs and medical cost outside the hospital will be assessing<br /><br>using the Indirect medical costs questionnaire, and Labor and Health<br /><br>Questionnaire. </p><br>
- Secondary Outcome Measures
Name Time Method <p>- In (good-)responders, duration of remission (relapse of disease: 50% loss of<br /><br>the obtained PASI improvement and/or need to retreat with UV and/or systemic<br /><br>therapy including biologicals) will be analysed.<br /><br>- In non-responders, patients perspectives of the comparative drug will be<br /><br>analysed.<br /><br>- Presence of neutralising antibodies will be measured to report if there is a<br /><br>possible link to inefficacy.<br /><br>- Side effects will be evaluated.<br /><br>- The improvement of nailpsoriasis will be evaluated by the Nail Psoriasis<br /><br>Severity index.</p><br>