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

• 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.; MedDRA version: 9.1Level: LLTClassification code 10050577Term: Psoriatic plaque

• Registration Number: EUCTR2008-007492-24-NL
• Lead Sponsor: Academic Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified