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.
Recruiting
- Conditions
- Psoriasis, Etanercept, Infliximab, Cost-effectiveness (kosteneffectiviteit)
- Registration Number
- NL-OMON23276
- Lead Sponsor
- Academic Medical Center (AMC), Department of dermatology
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
1. Adults patients (18-75 years of age)
2. Psoriasis Area and Severity Index (PASI > 10) and/or Body Surface Area (BSA) > 10.
Exclusion Criteria
1. Pregnancy and lactation.
2. Active (or chronic) infections including Hepatitis B and C viral infections, HIV and tuberculosis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy: <br /><br>- PASI75 and PGA as clinical psoriasis severity measures at week 12 and 24. <br /><br>-Improvement of HRQOL: Skindex-17, the generic SF-36 and PAGA. <br /><br>-Treatment satisfaction: Treatment Medication Satisfaction Questionnaire (TMSQ) score. <br /><br>- The incremental cost effectiveness ratio (ICER) of infliximab relative to etanercept will be calculated and estimated in terms of costs per QALY, by using the EQ-5D. <br /><br>- Nonmedical costs and medical cost outside the hospital, using the Labor and Health Questionnaire.
- Secondary Outcome Measures
Name Time Method - Duration of remission will be analysed.<br /><br>- Patients perspectives will be analysed. <br /><br>- Presence of neutralising antibodies will be measured.<br /><br>- Side effects will be evaluated. <br /><br>- The improvement of nailpsoriasis will be evaluated.<br />