Pharmacogenetic Trial and Long-term Follow-up of the PRISMS Trial (PRISMS-15)
PRISMS-15
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
1 other identifier
observational
290
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2010
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2009
CompletedFirst Posted
Study publicly available on registry
December 17, 2009
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedJuly 31, 2014
September 1, 2011
8 months
December 9, 2009
July 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The proportion of responders by group as defined by SNP (Single Nucleotide Polymorphism) markers
1 day
Secondary Outcomes (4)
Current course of MS: RRMS or SPMS
1 day
Current EDSS score
1 day
Change in EDSS since randomization
1 day
Immunogenicity assessment
1 day
Study Arms (1)
PRISMS patients
This single group includes all the patients from the PRISMS study
Eligibility Criteria
Group of patients coming from the PRISMS 6789 study
You may qualify if:
- Was randomized in the PRISMS study
- Is willing and able to comply with the protocol
- Written informed consent given before any trial-related activities are carried out
You may not qualify if:
- Is unwilling or unable to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Please call/email Central Contact for Recruiting Information in
Geneva, Switzerland
Related Publications (1)
Sormani MP, Freedman MS, Aldridge J, Marhardt K, Kappos L, De Stefano N. MAGNIMS score predicts long-term clinical disease activity-free status and confirmed disability progression in patients treated with subcutaneous interferon beta-1a. Mult Scler Relat Disord. 2021 Apr;49:102790. doi: 10.1016/j.msard.2021.102790. Epub 2021 Jan 22.
PMID: 33571946DERIVED
Biospecimen
Whole blood sampling for: Genetic markers BAbs/NAbs
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Elisabetta Verdun di Cantogno, MD
Merck Serono S.A., Geneva
Study Design
- Study Type
- observational
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2009
First Posted
December 17, 2009
Study Start
March 1, 2010
Primary Completion
November 1, 2010
Study Completion
January 1, 2011
Last Updated
July 31, 2014
Record last verified: 2011-09