CAM-THY

• Research type

  Research Study

• Full title

  Keratinocyte Growth Factor - promoting thymic reconstitution and preventing autoimmunity after alemtuzumab (Campath-1H) treatment of multiple sclerosis. CAM-THY

• IRAS ID

  98650

• Contact name

  Alasdair Coles

• Sponsor organisation

  Cambridgeshire and Peterborough NHS Foundation Trust

• Eudract number

  2011-005606-30

• ISRCTN Number

  n/a

• Research summary

  The purpose of this study is to prevent the main side effects of alemtuzumab - a drug with great promise as a treatment of multiple sclerosis. If this can be achieved, then greater numbers of people could access the benefits of the drug. In multiple sclerosis (MS) the patients?? own immune system attacks their brain and spinal cord. Alemtuzumab is probably the most effective drug treatment of multiple sclerosis tested to date; if given early in the disease, not only does it prevent new attacks, it also prevents people becoming more disabled and causes in most people an improvement in disability. Alemtuzumab works by killing immune cells (lymphocytes), after which the immune system grows back, ??better behaved?, without the immune cells which cause multiple sclerosis. Alemtuzumab has side effects, in particular 1 in 3 patients develop a new autoimmune disease after treatment. In other words, as their immune system grows back, it begins to attack other parts of their body; most commonly the thyroid gland. We believe that we can reduce the risk of autoimmune disease after treatment with alemtuzumab by using a drug which alters the way in which the immune system grows back. Kepivance (also known as Palifermin) has been shown to do this in animals. It works by boosting the function of the thymus, a gland in the neck which makes new immune cells. Kepivance is licensed for use in humans (for a different indication) and is well tolerated. This study is testing whether or not Kepivance will boost thymus function in humans. This study consists of a dose escalation sub-study and a main study. The dose escalation sub-study will be used to determine the dose of Kepivance to be used in the main study.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  12/LO/0393

• Date of REC Opinion

  25 Apr 2012

• REC opinion

  Further Information Favourable Opinion