A multi-center, open-label trial evaluating the Efficacy, Safety and the Impact on Quality of Life of Infliximab Therapy in patients with moderate to severe psoriasis not responding and/or intolerant to systemic standard or biologic therapy - ESAQUALITY. - ESAQUALITY

• Conditions: Moderate to severe psoriasis.; MedDRA version: 14.1Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2005-004465-41-IT
• Lead Sponsor: SCHERING-PLOUGH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-14
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Patients must be <=18 to 75 years of age, of eigher gender and of any race. - Patients must have psoriasis covering at least 10% of total BSA and PASI score of 12 or greater at screening and baseline. - Patients must have had a diagnosis of moderate to severe psoriasis at least 24 months prior to screening (patients with concurrent psoriatic arthritis may be enrolled). - Patients eligible to Infliximab treatment who have failed at least on of the following psoriasis treatments: Corticosteroids, MTX, systemic retinoids, Cyclosporine, PUVA, UVB phototherapy and/or biologics (etanercept or efalizumab). - Patients are considered eligible according to the tubercolosis (TB) eligibility assessment, screening and early detection of reactivation rules (specific section in the protocol). - Patients must have had a chest X-ray (posterior-anterior and lateral) within 3 months prior the screening with no evidence of malignancy, infections, or fibrosis. - Patients' screening and baseline test (CBC, blood chemistry, and urianalysis)must be within the following parameters: Hemoglobin: <= 10 g/dL White blood cells: <=3.5x109L Neutrophils: <=1.5x109L Platelets: <=100x109L Serum creatinine: >1.5 mg/dL AST, ALT, alkaline phosphatase and gamma-glutamyltransferase >= x upper normal limit of normal range for the laboratory conducting the test. Patients must be free of any clinically significant disease (other than psoriasis or psoriatic arthritis) that could interfere with the study evaluation. Patients must be willing to give written informed consent and be able to adhere to protocol visit and procedures.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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

- Standard concomitant psoriasis therapies. - Active or latent TB. - History of chronic infectious disease, opportunistic infection or serious infection within 2 months of enrollment. - History of lymphoproliferative disease. - Malignancy in past 5 years (except treated BCC). - Treatment with TNF antagonist within previous 12 weeks or other experimental drugs within previous 4 weeks. - Patients who have current-drug induced psoriasis. - Female patients who are pregnant or nursing. Patients previously treated with Infliximab. - Patients who have a concomitant diagnosis of CHF.

Study & Design

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