Este es un estudio de dos partes. Durante el período uno se realizará una comparación de etanercept (ETN) contra placebo, ambos brazos manteniendo el antiinflamatorio no esteroideo (AINE) de base prescrito por su médico. La hipótesis es que etanercept será superior al brazo placebo, determinado por la proporción de sujetos que logren una mejoría ASAS40 (Assessments in Ankylosing Spondylitis) a las 12 semanas. Esto será seguido por una extensión de 92 semanas donde todos los participantes del ensayo recibirán etanercept (ETN) y un AINE de base.
In Period 1, subjects will receive in a prefilled syringe with 1.0 ml (test article Etanercept (SC) once weekly . Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician.
Subject will continue to take a concomitant background non steroidal anti inflammatory drug(NSAID)as prescribed by their attending physician. The name and dose of this NSAID is the decision of the attending physician.
In Period 1 will receive a prefilled syringe of Placebo for Etanercept Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician.
Subject will continue to take a concomitant background non steroidal anti inflammatory drug(NSAID)as prescribed by attending physician (dose drug selection as tolerated and agreed upon by the attending Physician).
San Miguel de Tucumán, Tucumán Province, Argentina
Buenos Aires, Argentina