PRISMS-15

• Research type

  Research Study

• Full title

  A multinational, multicentre, single visit, exploratory pharmacogenetic trial and long-term follow-up of the PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) trial

• IRAS ID

  39833

• Contact name

  Cris Constantinescu

• Sponsor organisation

  Merck Serono S.A. - Geneva

• Eudract number

  2009-015502-19

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Multiple sclerosis (MS) is a chronic, inflammatory disease of the central nervous system (CNS). The exact cause of MS is unknown, although an autoimmune (body??s own response against own cells) process has been implicated. The inflammation results over time in demyelination (loss of the insulation material around the nerve cells which forms part of the nervous system) and ultimately loss of nerve cell axons (long threadlike extension of a nerve cell that conducts impulses away from the cell towards other nerve cells) and brain volume. It is important to understand why patients respond differently to drugs. DNA from blood has the potential to identify these differences. DNA is what genes are made of and which play a role in growth development and how the body functions. There are many variations in DNA from one person to another. These variations may affect a person??s chance of suffering from a particular disease or the way a person responds to a particular drug. The purpose of this study is to provide additional data on the genetic factors that could flunce the response to Interferon-beta-1a (Rebif) treatment and the long term efficacy of Rebif. Treatment was given to patients during the original PRISM study, a trial which took place 15 years ago. A long term follow up assessment of the PRISMs study was also conducted 8 years after the initial study. Participation will consist in one study visit during which 3 blood samples will be collected to identify factors fluncing patients?? response to treatment given in PRISMS and to also look at antibodies (proteins found in blood used by the immune system to identify and neutralise foreign objects) developed to Rebif. A neurological assessment as well as a revision to patients' MS status and treatment will also be carried out. This information will provide an insight on disease progression over the last 15 years after the patients?? initial enrolment in the PRISM study. This is a multicentre study taking place across 9 countries. We will invite all patients (560) who took part in the REGARD study

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  10/H1307/8

• Date of REC Opinion

  8 Feb 2010

• REC opinion

  Further Information Favourable Opinion