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).
