JC-virus (JCV) Epidemiology in Multiple Sclerosis (MS)
JEMS
Epidemiology of Anti-JCV Antibody Prevalence in Multiple Sclerosis Patients
1 other identifier
observational
7,726
0 countries
N/A
Brief Summary
The objective of the study is to estimate the prevalence of anti-JCV antibodies in multiple sclerosis (MS) participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2010
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2010
CompletedFirst Posted
Study publicly available on registry
August 20, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedJune 2, 2014
May 1, 2014
1.7 years
August 19, 2010
May 29, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Prevalence of anti-JCV antibodies
Prevalence of anti-JCV antibodies will be estimated as the number of participants with anti-JCV antibodies detected in serum divided by the total number of participants with a serum sample that was evaluated.
Single timepoint (Day 1)
Eligibility Criteria
Multiple Sclerosis (MS) patients will be enrolled in Europe, Canada, and Australia. Patient enrollment from each country will be commensurate with the distribution of MS patients among all participating countries.
You may qualify if:
- All candidates for this study must have the ability to understand the purpose of the study and provide signed and dated informed consent.
- All patients with a diagnosis of Multiple Sclerosis (MS) of any type, irrespective of their treatment, are eligible to participate once.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Related Publications (1)
da Silva AM, Santos ME; Portuguese JEMS Study Investigators. JCV epidemiology in MS (JEMS)--epidemiology of anti-JCV antibody prevalence in multiple sclerosis patients--Portuguese data. J Neurol Sci. 2014 Feb 15;337(1-2):119-22. doi: 10.1016/j.jns.2013.11.031. Epub 2013 Dec 1.
PMID: 24369270BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- observational
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2010
First Posted
August 20, 2010
Study Start
September 1, 2010
Primary Completion
May 1, 2012
Study Completion
June 1, 2012
Last Updated
June 2, 2014
Record last verified: 2014-05