Study Evaluating Etanercept for the Treatment of Moderate to Severe Psoriasis
NCT ID: NCT00663052
Last Updated: 2012-04-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
273 participants
INTERVENTIONAL
2008-06-30
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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Group A
A
Etanercept
ETN 50 mg QW + PBO QW for 12 weeks followed by ETN 50 mg QW for 12 weeks.
Group B
B
Etanercept
ETN 50 mg BIW for 12 weeks folowed ETN 50 mg QW for 12 weeks.
Interventions
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Etanercept
ETN 50 mg QW + PBO QW for 12 weeks followed by ETN 50 mg QW for 12 weeks.
Etanercept
ETN 50 mg BIW for 12 weeks folowed ETN 50 mg QW for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Capital Federal, Buenos Aires, Argentina
Pfizer Investigational Site
Capital Federal, Buenos Aires, Argentina
Pfizer Investigational Site
San Miguel, Buenos Aires, Argentina
Pfizer Investigational Site
Feldkirch, , Austria
Pfizer Investigational Site
Vienna, , Austria
Pfizer Investigational Site
Brussels, Belgium, Belgium
Pfizer Investigational Site
Ghent, , Belgium
Pfizer Investigational Site
Liège, , Belgium
Pfizer Investigational Site
Jihlava, , Czechia
Pfizer Investigational Site
Ostrava- Poruba, , Czechia
Pfizer Investigational Site
Plzen-Bory, , Czechia
Pfizer Investigational Site
Bochum, , Germany
Pfizer Investigational Site
Erlangen, , Germany
Pfizer Investigational Site
Frankfurt am Main, , Germany
Pfizer Investigational Site
Hamburg, , Germany
Pfizer Investigational Site
Kiel, , Germany
Pfizer Investigational Site
München, , Germany
Pfizer Investigational Site
Osnabrück, , Germany
Pfizer Investigational Site
Athens, , Greece
Pfizer Investigational Site
Athens, , Greece
Pfizer Investigational Site
Budapest, , Hungary
Pfizer Investigational Site
Debrecen, , Hungary
Pfizer Investigational Site
Miskolc, , Hungary
Pfizer Investigational Site
Szeged, , Hungary
Pfizer Investigational Site
Catanzaro, , Italy
Pfizer Investigational Site
L’Aquila, , Italy
Pfizer Investigational Site
Zapopan, Jalisco, Mexico
Pfizer Investigational Site
Monterrey, Nuevo Leon / Mexico, Mexico
Pfizer Investigational Site
Monterrey, Nuevo León, Mexico
Pfizer Investigational Site
Gangnam-gu, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Barcelona, Barcelona, Spain
Pfizer Investigational Site
Santiago de Compostela, La Coruña, Spain
Pfizer Investigational Site
Fuenlabrada, Madrid, Spain
Pfizer Investigational Site
Valencia, , Spain
Pfizer Investigational Site
Taipei, , Taiwan
Pfizer Investigational Site
Taipei TOC, , Taiwan
Pfizer Investigational Site
Bangkok, , Thailand
Countries
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References
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Kemeny L, Amaya M, Cetkovska P, Rajatanavin N, Lee WR, Szumski A, Marshall L, Mahgoub EY, Aldinc E. Effect of etanercept therapy on psoriasis symptoms in patients from Latin America, Central Europe, and Asia: a subset analysis of the PRISTINE trial. BMC Dermatol. 2015 May 21;15:9. doi: 10.1186/s12895-015-0028-8.
Griffiths CE, Christophers E, Szumski A, Jones H, Mallbris L. Impact of early vs. late disease onset on treatment response to etanercept in patients with psoriasis. Br J Dermatol. 2015 Nov;173(5):1271-3. doi: 10.1111/bjd.13865. Epub 2015 Aug 17. No abstract available.
Related Links
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Other Identifiers
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B1801013
Identifier Type: -
Identifier Source: secondary_id
0881A6-4425
Identifier Type: -
Identifier Source: org_study_id
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