ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01185717
Recruitment Status : Completed
First Posted : August 20, 2010
Last Update Posted : June 2, 2014
Sponsor:
Information provided by (Responsible Party):
Biogen

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

Condition or disease
Multiple Sclerosis

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
Actual Enrollment : 7726 participants
Time Perspective: Cross-Sectional
Official Title: Epidemiology of Anti-JCV Antibody Prevalence in Multiple Sclerosis Patients
Study Start Date : September 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01185717


Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen

Publications:
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01185717     History of Changes
Other Study ID Numbers: 100JC401
First Posted: August 20, 2010    Key Record Dates
Last Update Posted: June 2, 2014
Last Verified: May 2014

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