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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2007-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Etanercept

recommended dose of enbrel is 25mg administered twice weekly.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Wyeth

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Other Identifiers

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0881A1-101781

Identifier Type: -

Identifier Source: org_study_id