The Rebif vs Glatiramer Actetate in Relapsing Multiple Sclerosis Pharmacogenetics Trial (REGARD-PGx)
This study, REGARD-PGx is a single blood sampling exploratory pharmacogenetic study of the REGARD (the REbif vs Glatiramer Actetate in Relapsing MS Disease) trial.
The aim of this trial is to provide additional data on the factors influencing IFN beta response.
This is a Phase IV trial involving subjects who previously participated in the REGARD trial. To address the trial objectives, a single visit follow-up trial will be performed during which a blood sample will be collected.
|Study Design:||Time Perspective: Retrospective|
|Official Title:||A Multinational, Multicenter, Single Blood Sampling Exploratory Pharmacogenetic Study of the REGARD (the REbif vs Glatiramer Actetate in Relapsing MS Disease) Trial|
- Proportion of responders in each group defined by SNP (Single Nucleotide Polymorphism) 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. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- Treatment response data from REGARD will be used to analyze the association of genetic markers with efficacy parameters. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Whole blood sampling for genetic markers analysis
|Study Start Date:||March 2010|
|Study Completion Date:||January 2011|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
This single group includes all patients from the REGARD study 24735
|United States, Massachusetts|
|Please call Central Contact for Recruiting Information in|
|Rockland, Massachusetts, United States|
|Study Director:||Elisabetta Verdun di Cantogno, MD||Merck Serono S.A., Geneva|