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

This study has been completed.
Sponsor:
Collaborator:
Biogen Idec Australia Pty Ltd
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01185717
First received: August 19, 2010
Last updated: May 29, 2014
Last verified: May 2014

August 19, 2010
May 29, 2014
September 2010
May 2012   (final data collection date for primary outcome measure)
Prevalence of anti-JCV antibodies [ Time Frame: Single timepoint (Day 1) ] [ Designated as safety issue: No ]
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.
Estimate the prevalence of anti-JCV antibodies in MS patients [ Time Frame: one year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01185717 on ClinicalTrials.gov Archive Site
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JC-virus (JCV) Epidemiology in Multiple Sclerosis (MS)
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.

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.

Observational
Time Perspective: Cross-Sectional
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Non-Probability Sample

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.

Multiple Sclerosis
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7726
June 2012
May 2012   (final data collection date for primary outcome measure)

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.

Both
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Contact information is only displayed when the study is recruiting subjects
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NCT01185717
100JC401
No
Biogen Idec
Biogen Idec
Biogen Idec Australia Pty Ltd
Study Director: Medical Director Biogen Idec
Biogen Idec
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP