Remission outcomes of Etanercept plus methotrexate in patients with RA

• Research type

  Research Study

• Full title

  A 3-Phase Study to Evaluate Sustained Remission and Productivity Outcomes In Subjects With Early Rheumatoid Arthritis Initiated on Treatment With Etanercept Plus Methotrexate

• IRAS ID

  23024

• Contact name

  Paul Emery

• Sponsor organisation

  Parexel

• Eudract number

  2008-002623-85

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study is a 3-Phase Study to Evaluate Sustained Remission and Productivity Outcomes In Subjects With Early Rheumatoid Arthritis Initiated on Treatment With Etanercept Plus Methotrexate. Etanercept and DMARDs (disease-modifying anti-rheumatic drugs) such as methotrexate are drugs approved for use in the treatment of rheumatoid arthritis. Combination treatment with methotrexate and Etanercept has been shown to be highly effective in early rheumatoid arthritis. The purpose of this study is threefold: in the first part it will investigate whether Etanercept plus methotrexate is safe, and effective in treating early rheumatoid arthritis. In the second part it will investigate how safe and effective treatment with half the dose of Etanercept plus methotrexate is compared to methotrexate or to no treatment. The third part will investigate the effects of stopping treatment altogether. The study will also look at the effect treatment has on patients quality of life and the cost of various therapies.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  09/H1307/80

• Date of REC Opinion

  1 Oct 2009

• REC opinion

  Further Information Favourable Opinion