Alemtuzumab and rheumatoid arthritis - an immunisation study

• Research type

  Research Study

• Full title

  Alemtuzumab and rheumatoid arthritis - an immunisation study

• IRAS ID

  57019

• Contact name

  John Isaacs

• Sponsor organisation

  Newcastle upon Tyne Hospitals NHS Foundation Trust

• Eudract number

  2010-021146-22

• Research summary

  Between 1991 and 1994 we treated a number of rheumatoid arthritis patients with the monoclonal antibody CAMPATH-1H (also known as alemtuzumab). The treatment was designed to kill a certain type of white blood cell called a lymphocyte which we believe contributes to rheumatoid arthritis. These cells did not return back to normal numbers at the end of the treatment and, in most alemtuzumab recipients, have stayed low even after many years. Apart from low levels of lymphocytes, these patients do NOT otherwise appear to be immunosuppressed (inadequate immune system). It is important to assess whether there have been any long-term consequences on the health of alemtuzumab recipients and to try to establish whether their immune system is functioning normally. We performed similar studies 12 and 6 years ago which suggested no long-term adverse effects of the treatment but it is important to repeat this research at intervals. The best way to check the function of the immune system is to study the patient's ability to respond to immunisation. Participants in this study will be immunised with up to 3 vaccines (seasonafluvaccine; Pneumovax II; booster diphtheria, polio and tetanus vaccine). This particular study will compare the ability to mount an immune response in patients who received alemtuzumab for rheumatoid arthritis between 1991 and 1994 with a similar group of control patients who have not received the monoclonal antibody alemtuzumab (matched for disease duration, age and gender). It will also compare specific parameters of immune function, current disease activity and adverse event profiles between the two groups. Additionally, the study will update information on morbidity and mortality in the alemtuzumab group.

• REC name

  Scotland A REC

• REC reference

  10/MRE00/68

• Date of REC Opinion

  20 Dec 2010

• REC opinion

  Further Information Favourable Opinion