REGARD-PGx
Research type
Research Study
Full title
A multinational, multicentre, single blood sampling exploratory pharmacogenetic study of the REGARD (the REbif vs Glatiramer Acetate in Relapsing MS Disease) trial
IRAS ID
35902
Contact name
Cris Constantinescu
Sponsor organisation
Merck Serono S.A. - Geneva
Eudract number
2009-016087-37
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 neurones which forms part of the nervous system) and ultimately loss of axons and brain volume. It is important to understand why patients respond differently to drugs. DNA from blood is used 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 for 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) or to Glatiramer Acetate (Copaxone). These treatments were given to patients during the original REGARD study, a trial which took place 5 years ago. Participation will involve two blood samples used to identify factors fluncing patients' response to treatment given in REGARD. This is a multicentre study taking place across 12 countries (Europe, North and South America). We will invite all patients (650) who took part in the REGARD study
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
10/H1307/7
Date of REC Opinion
5 Feb 2010
REC opinion
Further Information Favourable Opinion