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
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