RITAZAREM: Rituximab vasculitis maintenance study

• Research type

  Research Study

• Full title

  An international, open label, randomised controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitis

• IRAS ID

  102101

• Contact name

  David Jayne

• Sponsor organisation

  Cambridge University Hospitals NHS Foundation Trust

• Eudract number

  2012-001102-14

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  Rituximab is a drug used for the treatment of ANCA-associated vasculitis, especially for those patients whose disease is relapsing. After a time, its effect wears off and the disease can return. This occurs in at least half of patients within 2 years of receiving Rituximab. A preliminary study has suggested that repeating rituximab every six months stops the disease returning and is safe. The RITAZAREM trial will find out whether repeating rituximab really works well in stopping vasculitis returning and whether it works better than azathioprine or methotrexate. It will also tell us how long patients remain well after the repeated rituximab treatments are stopped, and if repeated rituximab is safe. The trial results will help decide the best treatment for future patients who have their vasculitis initially treated with rituximab. Relapsing vasculitis patients enrolled into the trial will be treated with rituximab and steroids. If their disease is under reasonable control after four months, further treatment with either rituximab or azathioprine will be chosen randomly. The patients in the rituximab and azathioprine groups will then be compared. Patients will be in the trial for a total of 4 years. We plan to include 190 participants with ANCA-associated vasculitis from 30 hospitals worldwide. Some of these hospitals will be located in the USA and they will be conducting an identical parallel study which will be sponsored and funded separately in the US. The US sites will be working to the same protocol (as submitted as part of this application), and all data will be collected on an identical case report form to that of our sponsored sites. All data will be entered into a single study database held in Cambridge and will be analysed as a single data set by the study statistician. The participant numbers required for this study as detailed in this application, also include recruitment figures for the US sites. However from a legal perspective, the parallel study in the US will be separately sponsored, funded and conducted to this study.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  12/EE/0230

• Date of REC Opinion

  24 Jul 2012

• REC opinion

  Further Information Favourable Opinion