The diagnosis, evaluation and treatment of rheumatoid arthritis (RA) continue to undergo
rapid change. Randomized controlled trials such as the TEMPO study have demonstrated the
efficacy and safety of the combination of etanercept and methotrexate. Importantly, the TEMPO
study showed that patients treated with etanercept and methotrexate could reach the newer
therapeutic goals of low disease activity and remission, and that the physicians, patients,
and payers are no longer prepared to accept the goal of "Reduction of symptoms". RCT are
important and powerful tools in assessing efficacy and safety but have their limitations in
terms of generalisability. In order to assess health economics, clinical effectiveness and
safety of etanercept, they need to be measured by performing observational studies of
unselected patients. This study aims to provide a holistic assessment of patients receiving
etanercept in a real world setting. This will include centers that would not normally take
part in RCT. The study will assess treatment with etanercept with descriptive statistics of
the following parameters: Health economic, Safety, Effectiveness. In addition, there was a
previous study of similar design, but of only 3 months duration (101354), which will allow
comparison with historical data. Since previous study, there have been a number of
significant changes: Introduction of a new formulation for etanercept (Enbrel® 50mg · once
weekly), Definition of early RA has been modified to short disease duration (from 3 months to
1 year).
