A multinational, multicenter, single blood sampling exploratory pharmacogenetic study of the REGARD (the REbif vs Glatiramer Acetate in Relapsing MS Disease) trial - REGARD-PGx

INTERVENTION: Pharmaceutical Form: CONDITION: Multiple Sclerosis ; MedDRA version: 12.0 Level: PT Classification code 10028245 Term: Multiple sclerosis PRIMARY OUTCOME: Main Objective: To analyze the association between single nucleotide polymorphisms (SNP) markers and Rebif and Copaxone treatment response. Treatment response is based on EDSS progression and relapse outcomes over the 96 weeks of treatment in the REGARD trial. Primary end point(s): The primary endpoint is defined as the proportion of responders in each group defined by SNP markers. A responder is defined as a subject with no MS relapse and no EDSS progression during the 96 weeks (2 years) of treatment of REGARD 24735 trial. Secondary Objective: To analyze the association between genetic markers with responses to treatment for efficacy, safety and immunogenicity parameters. INCLUSION CRITERIA: For inclusion in the trial, all of the following inclusion criteria must be fulfilled: The subject 1.Was randomized in the REGARD 24735 study 2.Is willing and able to comply with the protocol 3.Has given written informed consent before performing any trial‐related activities. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range