SWITCH version 1.0

• Research type

  Research Study

• Full title

  SWITCH: Randomised-controlled trial of switching to alternative tumour-necrosis factor (TNF)-blocking drugs or abatacept or rituximab in patients with rheumatoid arthritis who have failed an initial TNF-blocking drug.

• IRAS ID

  63998

• Contact name

  Maya Buch

• Sponsor organisation

  Leeds Teaching Hospital NHS Trust

• Eudract number

  2010-023880-17

• ISRCTN Number

  ISRCTN89222125

• Research summary

  Rheumatoid arthritis (RA) is the most common treatable cause of disability in the Western world. RA affects over 600,000 people in the UK: symptoms impact heavily on patients' ability to perform daily activities at home and ability to undertake work commitments. It is therefore vital to treat this condition effectively and with the minimum of time delay. There have been dramatic advances recently in the development of effective drugs to treat RA with the use of Tumour Necrosis Factor (TNF)-blocking drugs which have transformed the lives of People'suffering from RA. While these drugs are highly effective overall, some patients do not respond well for reasons we do not fully understand yet. Initial studies have shown that when a TNF-blocking drug does not work, switching to one of the other TNF-blocking drugs can be effective. In addition to these drugs, two new drugs, rituximab and abatacept, have also been licensed for patients who fail a TNF-blocking drug. However, the National Institute of Clinical Excellence (NICE) have only approved the use of rituximab which means that patients have only one option (rituximab); this option is unsuccessful in reducing disease symptoms in a third of patients. SWITCH is aiming to provide those RA patients who have failed to respond with an initial TNF-blocker with more treatment choices based on a thorough evaluation of the currently licensed drugs available. In order to make a fair assessment to whether the alternative treatments we propose are as good as rituximab, patients will be randomly allocated into three groups; one group will receive rituximab; another group will receive abatacept and the third group will receive an alternative mechanism TNF-blocking drug. 870 patients from hospitals throughout the UK will be recruited into the study over 30 months. Each patient??s participation in the study will last 96 weeks. Rheumatoid arthritis (RA) is the most common treatable cause of disability in the Western world. RA affects over 600,000 people in the UK: symptoms impact heavily on patients' ability to perform daily activities at home and ability to undertake work commitments. It is therefore vital to treat this condition effectively and with the minimum of time delay.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  11/H1307/6

• Date of REC Opinion

  21 Feb 2011

• REC opinion

  Further Information Favourable Opinion