ORBIT study

• Research type

  Research Study

• Full title

  Optimal management of rheumatoid arthritis patients who require biologic therapy (ORBIT study)

• IRAS ID

  12570

• Contact name

  Duncan Porter

• Sponsor organisation

  NHS Greater Glasgow and Clyde

• Eudract number

  2009-011268-13

• Clinicaltrials.gov Identifier

  01021735

• Research summary

  The primary purpose of the trial is to identify whether rituximab therapy or anti-TNF therapy is more effective in improving the clinical symptoms, signs, physical function and health-related quality of life of patients with active rheumatoid arthritis. The secondary purposes are to 1) assess the relative cost-effectiveness of these treatment 2) prospectively evaluate the flunce of mood on response to, and side effect profile from, anti-TNF and rituximab 3)identify whether synovial immuno-histology at baseline predicts differential response to rituximab and anti-TNF therapy.

• REC name

  West of Scotland REC 1

• REC reference

  09/S0703/109

• Date of REC Opinion

  3 Nov 2009

• REC opinion

  Further Information Favourable Opinion