Tolerance induction with intravenous IFNβ-1a

• Research type

  Research Study

• Full title

  An exploratory phase IIa study to evaluate the safety and immunological effects of intravenous interferonß-1a (IFNß-1a, Rebif®) therapy in the induction of tolerance to IFNß in MS patients with neutralising antibodies (NAbs) to subcutaneous IFNß-1a (Rebif® or Avonex®)

• IRAS ID

  2879

• Contact name

  Gavin/G Giovannoni

• Sponsor organisation

  Queen Mary, University of London

• Eudract number

  2008-000256-26

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  Multiple Sclerosis (MS) is a neurological disease that affects young adults and causes serious disability. Interferon-beta (IFN×ý-1a) is a naturally occurring substance produced by our bodies. Interferon-beta (IFN×ý-1a) is now synthetically manufactured and constitutes one of the drugs licensed in the UK to alter the course of MS. People who are treated with IFN×ý-1a can develop antibodies that neutralize the effect of the drug and the beneficial effects from IFN×ý-1a will fade. The aim of the study drug is to try to overcome the immunological reaction that causes the formation of neutralizing antibodies and in doing so enable the patients to respond to the IFN×ý-1a treatment once again. This strategy would also be useful in immunological diseases such as lupus or rheumatoid arthritis, once it is discovered which substances in our bodies cause our immune system to react and produce antibodies. The planned study will use a single dose of mitoxantrone, which is an immunosuppressive drug already used in MS on a repetitive schedule, to reduce the number of cells that are reactive against IFN×ý-1a. This should encourage the growth and maturation of new immune cells and in turn be released into the blood stream. Within study parameters, IFN×ý-1a itself will be given intravenously and at high doses. A further aim of the study is to understand the cellular mechanism involved in the process of reversal to NAb negative status. It is expected that the intravenous route will cause less and a slightly different immune response to the high doses of IFN×ý-1a, may help the IFN×ý-1a -specific cells to be over activated and die.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  08/H0305/64

• Date of REC Opinion

  16 Feb 2009

• REC opinion

  Further Information Favourable Opinion