EUCTR2008-007492-24-NL
Active, not recruiting
Not Applicable
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 - PIECE
Academic Medical Center0 sites120 target enrollmentJanuary 27, 2009
ConditionsPatients 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: 9.1Level: LLTClassification code 10050577Term: Psoriatic plaque
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- 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.
- Sponsor
- Academic Medical Center
- Enrollment
- 120
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
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\.
- •\- 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
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.
Outcomes
Primary Outcomes
Not specified
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