Last updated on October 2017

Study of Etanercept Monotherapy vs Methotrexate Monotherapy for Maintenance of Rheumatoid Arthritis Remission


Brief description of study

The purpose of this study is to evaluate the efficacy of etanercept monotherapy compared to methotrexate monotherapy on maintenance of remission in subjects with Rheumatoid Arthritis who were on etanercept plus methotrexate therapy. This is a multicenter, randomized withdrawal, double-blind controlled study in subjects with Rheumatoid Arthritis on etanercept plus methotrexate therapy who are in very good disease control for 6 months prior to study entry. The study will consist of a 30-day screening period, a 24-week open label run-in period, a 48-week double-blind treatment period and a 30-day safety follow-up period. Approximately 465 subjects will be enrolled and approximately 325 subjects will be randomly assigned in a 2:2:1 ratio to one of three treatment groups: etanercept 50 mg weekly by subcutaneous injection plus oral placebo for methotrexate (n = 130), oral methotrexate 10 to 25 mg weekly plus placebo for etanercept (n = 130) and etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly (n = 65).

Clinical Study Identifier: NCT02373813

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Research Site
Uherske Hradiste, Czechia
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