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

CompletadoFase 4ClinicalTrials.gov

ID: NCT00663052Tipo: INTERVENTIONALInicio: 1 de jun de 2008Fin estimado: 1 de ene de 2010

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

Etanercept

ETN 50 mg QW + PBO QW for 12 weeks followed by ETN 50 mg QW for 12 weeks.

drug

Etanercept

ETN 50 mg BIW for 12 weeks folowed ETN 50 mg QW for 12 weeks.

Ubicaciones

Pfizer Investigational Site

Capital Federal, Buenos Aires, Argentina

Pfizer Investigational Site

Capital Federal, Buenos Aires, Argentina

Pfizer Investigational Site

San Miguel, Buenos Aires, Argentina

Patrocinadores

PrincipalPfizer

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