Pharmacogenetic Trial and Long-term Follow-up of the PRISMS Trial (PRISMS-15)
This study, PRISMS-15 is a 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.
The aim of this trial is to provide additional data on the driving factors of IFN beta response and the long-term outcomes of Rebif® treatment.
This is a Phase IV trial involving subjects who previously participated in the PRISMS trial. To address the trial objectives, a single visit will be performed, at least 3 months after the onset of the last relapse.
|Study Design:||Time Perspective: Retrospective|
|Official Title:||A Multinational, Multicenter, 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|
- The proportion of responders by group as defined by SNP (Single Nucleotide Polymorphism) markers [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- Current course of MS: RRMS or SPMS [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- Current EDSS score [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- Change in EDSS since randomization [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- Immunogenicity assessment [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Whole blood sampling for:
Genetic markers BAbs/NAbs
|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 the patients from the PRISMS study
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034644
|Please call/email Central Contact for Recruiting Information in|
|Study Director:||Elisabetta Verdun di Cantogno, MD||Merck Serono S.A., Geneva|