DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Summary

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.

Eligibility

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

Criteria:

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

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014