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
  Purpose

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


Condition
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 Idec:

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.

  Eligibility

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.

Criteria

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.

  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 ClinicalTrials.gov identifier: NCT01185717

Sponsors and Collaborators
Biogen Idec
Biogen Idec Australia Pty Ltd
Investigators
Study Director: Medical Director Biogen Idec
  More Information

Publications:
Responsible Party: Biogen Idec
ClinicalTrials.gov 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
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014