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

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT01185717
• Lead Sponsor: Biogen

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2010-08-19
• Study First Submitted QC: 2010-08-19
• Study First Posted: 2010-08-20
• Study Start: 2010-09
• Primary Completion: 2012-05
• Study Completion: 2012-06
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-29
• Last Update Posted: 2014-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7726

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

• None

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of anti-JCV antibodies	Single timepoint (Day 1)	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.