NL-OMON35488
Not yet recruiting
Phase 4
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 - Independent RCT comparing infliximab and enbrel in psoriasis. PIECE study
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- chronic skin disease with increased keratinization
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 120
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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.
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
- •\- 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
Outcomes
Primary Outcomes
Not specified
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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.Psoriasis, Etanercept, Infliximab, Cost-effectiveness (kosteneffectiviteit)NL-OMON23276Academic Medical Center (AMC), Department of dermatology120