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Study Evaluating Etanercept for the Treatment of Moderate to Severe Psoriasis

Information source: Wyeth
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Plaque Psoriasis; Psoriasis

Intervention: Etanercept (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth

Overall contact:
Trial Manager, Email: clintrialparticipation@wyeth.com


The purpose of this study is to compare the safety and efficacy of different doses of etanercept for the treatment of moderate to severe psoriasis.

Clinical Details

Official title: A Randomized, Double-Blind Trial Assessing the Efficacy and Safety of Etanercept 50 mg Twice Weekly and Etanercept 50 mg Once Weekly for the Treatment of Moderate to Severe Psoriasis

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Single Group Assignment, Safety/Efficacy Study

Primary outcome: Change in PASI Scores from at Week 24.

Secondary outcome: Effect of Etanercept on the QoL of each Treatment Group.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria

- 18 years of age or older at time of consent.

- Active, moderate to severe chronic plaque psoriasis defined by the following criteria:

Clinically stable, plaque psoriasis involving greater than or equal to 10% body surface area (BSA) or PASI greater than or equal to 10.

- In the opinion of the investigator, failure, intolerance, contraindication or not a

candidate for the following: Methotrexate (MTX), cyclosporine and psoralen plus ultraviolet A radiation (PUVA) therapy.

Exclusion Criteria

- Evidence of skin conditions (e. g., eczema) other than psoriasis that would interfere

with evaluations of the effect of study medication on psoriasis.

- Rheumatologic disease such as rheumatoid arthritis, systemic lupus erythematous,

systemic vasculitis, scleroderma and polymyositis, or associated syndromes.

- Active or recent (within 2 years) tuberculosis (TB) infection.

Locations and Contacts

Trial Manager, Email: clintrialparticipation@wyeth.com

Provincia de Buenos Aires CP 1114, Argentina; Not yet recruiting

El Palomar, Buenos Aires CP 1114, Argentina; Not yet recruiting

Feldkirch A-6800, Austria; Not yet recruiting

Wein A-1030, Austria; Not yet recruiting

Liege 4000, Belgium; Not yet recruiting

Gent 9000, Belgium; Not yet recruiting

Sao Paulo 101, Brazil; Not yet recruiting

Ostrava-Poruba 70800, Czech Republic; Not yet recruiting

Pilsen 305 99, Czech Republic; Recruiting

Jihlava 586 33, Czech Republic; Recruiting

Frankfort/Main D-60950, Germany; Recruiting

Hamburg D-202046, Germany; Not yet recruiting

Kiel D-24105, Germany; Not yet recruiting

Athens 16121, Greece; Not yet recruiting

Athens 12464, Greece; Not yet recruiting

Debrecen H-4012, Hungary; Recruiting

Miskolc H-3529, Hungary; Recruiting

Catanzaro 88110, Italy; Not yet recruiting

L'Aquila 67100, Italy; Not yet recruiting

Seoul 135-710, Korea, Republic of; Not yet recruiting

Seoul 110-744, Korea, Republic of; Not yet recruiting

Zapopan 45190, Mexico; Not yet recruiting

Monterrey 64710, Mexico; Not yet recruiting

Mexico City 1120, Mexico; Not yet recruiting

Voorburg 2275 CX, Netherlands; Active, not recruiting

Rotterdam 3015 CA, Netherlands; Active, not recruiting

Barcelona 08025, Spain; Not yet recruiting

Valencia 46014, Spain; Recruiting

Santiago de Compostela 15706, Spain; Not yet recruiting

Madrid 28942, Spain; Not yet recruiting

Taipei 100, Taiwan; Not yet recruiting

Taipei City 110, Taiwan; Not yet recruiting

Bangkok 10330, Thailand; Not yet recruiting

Bangkok 10400, Thailand; Not yet recruiting

Additional Information

Starting date: May 2008
Ending date: October 2009
Last updated: November 26, 2008

Page last updated: February 12, 2009

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