The purpose of this study is to learn more about the role of etanercept alone or in combination with methotrexate on disease activity in subjects with psoriatic arthritis. To do this, etanercept alone will be compared to methotrexate alone or to combination etanercept and methotrexate.This study will last approximately 1 year (52 weeks) for an individual subject. Subjects will be randomized into 1 of 3 groups. Subjects will have a 1 in 3 chance of receiving etanercept plus methotrexate, etanercept alone or methotrexate alone. Neither the subject nor the study doctor can choose the group to which the subject will be randomized into. Subjects will take one study medication by injection under their skin and a second medication taken by mouth. After the first 24 weeks of the study, if the doctor evaluates the subject and determines that their condition has not improved, the subject may qualify to receive etanercept plus methotrexate.
A Multicenter Double-Blind, Randomized Controlled Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects With Psoriatic Arthritis
This is a multicenter, randomized, double-blind controlled study to evaluate the efficacy of etanercept plus methotrexate therapy and etanercept monotherapy compared to methotrexate monotherapy, in subjects with PsA as measured by the proportion of subjects achieving an American College of Rheumatology (ACR) 20 response and Minimal Disease Activity (MDA) at week 24.The study will consist of a 30-day screening period, a 48-week double-blind treatment period and a 30-day safety follow-up period. Approximately 840 subjects will be randomly assigned in a 1:1:1 ratio to one of three treatment groups (280 per group): etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 20 mg weekly, etanercept 50 mg weekly by subcutaneous injection plus oral placebo for methotrexate, and oral methotrexate 20 mg weekly plus placebo for etanercept. Starting at week 24 visit, subjects who have an inadequate response will be provided rescue treatment of etanercept plus methotrexate for the remainder of the study.