JC-virus (JCV) Epidemiology in Multiple Sclerosis (MS)

Multiple Sclerosis Clinical Trial

— JEMS  

Official title:

Epidemiology of Anti-JCV Antibody Prevalence in Multiple Sclerosis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01185717
• Other study ID #: 100JC401
• Status: Completed
• Phase: N/A
• First received: August 19, 2010
• Last updated: May 29, 2014
• Start date: September 2010
• Est. completion date: June 2012

Study information

• Verified date: May 2014
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeAustria: EthikkommissionPortugal: Ethics Committee for Clinical ResearchUnited Kingdom: Research Ethics CommitteeNetherlands: Independent Ethics CommitteeBelgium: Institutional Review BoardGermany: Ethics CommissionAustralia: Human Research Ethics CommitteeIreland: Research Ethics CommitteeSwitzerland: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The objective of the study is to estimate the prevalence of anti-JCV antibodies in multiple sclerosis (MS) participants.

Description:

This is a cross-sectional, multi-center, multi-national, epidemiological study to estimate the prevalence of anti-JCV antibody in MS participants. This study will provide an estimate of the prevalence of anti-JCV antibody in the MS population and will investigate inter-country differences.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7726
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Key Inclusion Criteria:

• 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.

Key Exclusion Criteria:

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No