Estudio descriptivo, aleatorizado, abierto, con grupos paralelos, de 3 meses de duración para explorar y comparar la percepción y la satisfacción en cuanto a dos mecanismos de administración de Etanercept diferentes (autoinyectable de Etanercept y jeringa precargada de Etanercept) en pacientes con psoriasis.A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study to Explore and Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept (Etanercept Autoinjector and the Etanercept Prefilled Syringe) in Patients with Psoriasis.

• Conditions: PSORIASIS

• Registration Number: EUCTR2006-006309-96-ES
• Lead Sponsor: Wyeth Pharmaceuticals France

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-04
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 524

Inclusion Criteria

· Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA
· Eligible for treatment with etanercept according to Summary of Product Characteristics (SmPC), and applicable local guidelines.
· Aged 18 years or more
· Willing and able to self-inject etanercept.
· Able to store test drug at 2-8°C.
· Negative serum ß-human chorionic gonadotropin (ß-HCG) pregnancy test at baseline (week 0) for all women of childbearing potential. Sexually active women of childbearing potential must use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. Sexually active men must agree to use a reliable form of contraception during the study.
· Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol-specific procedures are performed.
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

· Prior experience of biologic treatment for their Psoriasis including etanercept.
· Sepsis or risk of sepsis.
· Current or recent infections, including chronic or localized.
· Latex sensitivity.
· Vaccination with live vaccine in last 4 weeks, or expected to require such vaccination during the course of the study.Patients with the following conditions or risk factors should only be entered into the study if the investigator has conducted and documented a full risk/benefit evaluation:
· History of recurring or chronic infection, or underlying condition which may predispose patients to infections e.g. Tuberculosis (TB) infection (Note: follow local country guidelines for appropriate screening and treatment of tuberculosis in the setting of anti-TNF therapy), serious infection (infection associated with hospitalization and/or intravenous antibiotics) within 1 month of test article administration or active infection at screening, open cutaneous ulcers, known human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) positive.
· Current or prior history of blood dyscrasias. Abnormal safety baseline blood test e.g. hemoglobin =85 g/L; hematocrit =27 %; platelet count =125 x 109 /L; white blood cell count =3.5 x 109 /L; serum creatinine =175 µmol/L; aspartate aminotransferase (AST [SGOT]) and alanine aminotransferase (ALT [SGPT]) =2 times the laboratory’s upper limit of normal.
· Pre-existing or recent onset CNS demyelinating disease.
· Cardiovascular conditions, e.g., myocardial infarction within 12 months of the screening visit, unstable angina pectoris, class III or IV congestive heart failure as defined by the New York Heart Association classification (4) or decompensated congestive heart failure.
· Uncontrolled conditions, e.g., diabetes mellitus, hypertension (defined as screening systolic blood pressure > 160 mm Hg or screening diastolic blood pressure > 100 mm Hg), severe pulmonary disease requiring hospitalization or supplemental oxygen.
· At increased risk of malignancy.

Study & Design

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