Pharmacogenetic Trial and Long-term Follow-up of the PRISMS Trial (PRISMS-15) (PRISMS-15)
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|ClinicalTrials.gov Identifier: NCT01034644|
Recruitment Status : Completed
First Posted : December 17, 2009
Last Update Posted : July 31, 2014
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||290 participants|
|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|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||January 2011|
This single group includes all the patients from the PRISMS study
- The proportion of responders by group as defined by SNP (Single Nucleotide Polymorphism) markers [ Time Frame: 1 day ]
- Current course of MS: RRMS or SPMS [ Time Frame: 1 day ]
- Current EDSS score [ Time Frame: 1 day ]
- Change in EDSS since randomization [ Time Frame: 1 day ]
- Immunogenicity assessment [ Time Frame: 1 day ]
Biospecimen Retention: Samples With DNA
Whole blood sampling for:
Genetic markers BAbs/NAbs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01034644
|Please call/email Central Contact for Recruiting Information in|
|Study Director:||Elisabetta Verdun di Cantogno, MD||Merck Serono S.A., Geneva|