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

This study has been completed.
Information provided by (Responsible Party):
Biogen Identifier:
First received: August 19, 2010
Last updated: May 29, 2014
Last verified: May 2014
The objective of the study is to estimate the prevalence of anti-JCV antibodies in multiple sclerosis (MS) participants.

Multiple Sclerosis

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Epidemiology of Anti-JCV Antibody Prevalence in Multiple Sclerosis Patients

Resource links provided by NLM:

Further study details as provided by Biogen:

Primary Outcome Measures:
  • 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.

Enrollment: 7726
Study Start Date: September 2010
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.


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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01185717

Sponsors and Collaborators
Study Director: Medical Director Biogen
  More Information

Responsible Party: Biogen Identifier: NCT01185717     History of Changes
Other Study ID Numbers: 100JC401 
Study First Received: August 19, 2010
Last Updated: May 29, 2014
Health Authority: Canada: Ethics Review Committee
Austria: Ethikkommission
Portugal: Ethics Committee for Clinical Research
United Kingdom: Research Ethics Committee
Netherlands: Independent Ethics Committee
Belgium: Institutional Review Board
Germany: Ethics Commission
Australia: Human Research Ethics Committee
Ireland: Research Ethics Committee
Switzerland: Ethics Committee

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases processed this record on October 25, 2016