The objective of the study is to estimate the prevalence of anti-JCV antibodies in MS patients,including the following criteria:* Age* Gender* Race* Country of birth and the duration of residence* Current country of residence and the duration of…
ID
Source
Brief title
Condition
- Central nervous system infections and inflammations
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 objective of the study.
Secondary outcome
Not applicable
Background summary
Biogen Idec Inc. (Biogen Idec) has developed an analytically validated
enzyme-linked
immunosorbent assay (ELISA) to detect the presence of JCV antibody in serum.
Available data
with this assay, evaluating a geographically diverse subset of the multiple
sclerosis (MS)
population, consisting of over 800 patients, indicate that the prevalence of
anti-JCV-specific
antibodies (i.e., seroprevalence) is 53.6% with a 95% confidence interval (CI)
of 49.9% to
57.3%, and an annual rate of seroconversion (i.e. change from anti-JCV antibody
negative to
anti-JCV antibody positive status) of approximately 2%, and a false negative
rate of 2.5%
(unpublished data). The prevalence of anti-JCV antibodies requires confirmation
in the MS
population as a whole.
Study objective
The objective of the study is to estimate the prevalence of anti-JCV antibodies
in MS patients,
including the following criteria:
* Age
* Gender
* Race
* Country of birth and the duration of residence
* Current country of residence and the duration of residence
* Country of longest residence
* Type and duration of MS
* Prior and current immunomodulatory and immunosuppressant therapies for MS and
the duration of these MS therapies
* Prior and current immunomodulatory and immunosuppressant therapies not for MS
and the duration of such therapies
Study design
This is a cross-sectional, multicenter, multinational, epidemiological study.
Study burden and risks
not applicable, study is non-invasive
Innovation House, 70 Norden Road
Maidenhead Berkshire SL6 4AY
GB
Innovation House, 70 Norden Road
Maidenhead Berkshire SL6 4AY
GB
Listed location countries
Age
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
All candidates not able to understand the purpose of the study and not able to provide signed and dated informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL33336.029.10 |