Alemtuzumab for ANCA-Associated Refractory Vasculitis

• Research type

  Research Study

• Full title

  Alemtuzumab for ANCA-Associated Refractory Vasculitis - A study of safety and efficacy (ALEVIATE).

• IRAS ID

  31900

• Contact name

  David Jayne

• Sponsor organisation

  Addenbrooke's Hospital

• Eudract number

  2009-017087-17

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  Anti-neutrophil cytoplasm antibody (ANCA) associated vasculitis (AAV) is a severe disease of unknown cause when the immune system attacks and injures various tissues in the body. Patients with AAV develop kidney and lung disease and their lives are threatened. The use of high doses of steroids and other drugs that suppress the immune system, such as cyclophosphamide, has allowed doctors to control vasculitis. However, there are three important ongoing issues. Alternative therapies are needed as: 1)About 1 in 5 patients will not respond to these drugs and their disease continues uncontrolled causing organ damage. 2) In those that do initially respond to these drugs, AAV has a tendency to return when the drugs are reduced or withdrawn. 3) These drugs are toxic and have many side effects, which can cause more problems than the disease itself. Alemtuzumab is a newer drug that is effective in other immune disorders, such as multiple sclerosis. This study will examine the use of alemtuzumab in 24 patients whose vasculitis is not controlled by standard drugs. It will be a multi-centre dose ranging study, with patients being followed up for 12 months. The hope is that alemtuzumab will lead to the control of disease for many months or even years without the need for any additional drugs, including steroids, thereby minimising drug toxicity.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  10/H0304/64

• Date of REC Opinion

  29 Sep 2010

• REC opinion

  Further Information Favourable Opinion