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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01185717
First received: August 19, 2010
Last updated: November 1, 2012
Last verified: November 2012
History of Changes
  Purpose

This is a cross-sectional, multi-center, multi-national, epidemiological study to estimate the prevalence of anti-JCV antibodies in MS patients.


Condition
Multiple Sclerosis

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Estimate the prevalence of anti-JCV antibodies in MS patients [ Time Frame: Single timepoint ] [ Designated as safety issue: No ]

Enrollment: 2000
Study Start Date: September 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Prevalence of anti-JCV antibodies will be estimated as the number of patients with anti-JCV antibodies detected in serum divided by the total number of patients with a serum sample that was evaluated. Prevalence of anti-JCV antibodies will also be estimated by the criteria described in the protocol

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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 MS of any type, irrespective of their treatment, are eligible to participate once.

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01185717

  Show 69 Study Locations
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01185717     History of Changes
Other Study ID Numbers: 100JC401
Study First Received: August 19, 2010
Last Updated: November 1, 2012
Health Authority: Canada: Ethics Review Committee
Switzerland: Ethics Committee
Austria: Ethikkommission
Ireland: Ethics Committee
United Kingdom: Research Ethics Committee
Netherlands: Independent Ethics Committee
Czech Republic: Ethics Committee
Belgium: Institutional Review Board
Germany: Ethics Commission
Australia: Human Research Ethics Committee
Portugal: Ethics Committee

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013