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

December 26, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

Evaluating Safety in Patients With Moderate to Severe Psoriasis Treated With Etanercept

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 Overview

Status

Completed

Conditions

Psoriasis

Intervention / Treatment

Drug: Etanercept

Study Type

Interventional

Enrollment (Actual)

500

Phase

Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dermatology Quality of Life Index, Psoriasis Quality of Life Index and Physician Global assessment Time Frame: 18 months	18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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	18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)