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

May 29, 2014 updated by: Biogen

Epidemiology of Anti-JCV Antibody Prevalence in Multiple Sclerosis Patients

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

7726

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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:

  • None

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of anti-JCV antibodies
Time Frame: 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.
Single timepoint (Day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

August 19, 2010

First Submitted That Met QC Criteria

August 19, 2010

First Posted (Estimate)

August 20, 2010

Study Record Updates

Last Update Posted (Estimate)

June 2, 2014

Last Update Submitted That Met QC Criteria

May 29, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100JC401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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