Study Evaluating Safety of Etanercept in Treatment of Patients With Moderate to Severe Psoriasiswith Etanercept

Wyeth is now a wholly owned subsidiary of Pfizer500 enrolled

Overview

Evaluate (i) safety of etanercept in patients with moderate to severe psoriasis in Spain; (ii) the incidence of adverse events reported in these patients, and (iii) the role that age and concomitant therapy might play in the development of adverse reactions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

500

Conditions

Psoriasis

Interventions

EtanerceptDRUG

recommended dose of enbrel is 25mg administered twice weekly.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Informed consent signed by patients prior to study entry 2. 18 years of age or older at screening visit 3. Patients with moderate to severe psoriasis 4. Patients who have failed conventional systemic treatment 5. Patients who have a contraindication to conventional systemic therapy 6. Patients who are intolerant to conventional systemic therapy 7. A negative serum pregnancy test at screening in women of childbearing potential 8. Able to self-inject study drug or have a designee who can do so 9. In the opinion of the investigator, the patient will be able to comply with the requirements of the protocol

Outcomes

Primary Outcomes

Dermatology Quality of Life Index, Psoriasis Quality of Life Index and Physician Global assessment

Time frame: 18 months

Secondary Outcomes

Reduction and/or withdrawal of systemic therapies, Proportion of patients with plaque psoriasis achieving PASI 50, 75 and 90 at each evaluation and BSA at each evaluation

Time frame: 18 months

Data from ClinicalTrials.gov

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