JC-Virus (JCV) Antibody Program

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1096 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-06-30

Brief Summary

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The primary objective is to define the prevalence of serum anti-JCV antibody in relapsing multiple sclerosis (MS) participants receiving Tysabri® (natalizumab) or being considered for such treatment. Secondary objectives are to analytically validate the anti-JCV antibody assay in a plasma matrix and to determine changes in anti-JCV antibody status over time.

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Detailed Description

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This study requires serum, plasma and urine collection at enrollment and every 6 months thereafter for up two years.

Conditions

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Multiple Sclerosis

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Relapsing Multiple Sclerosis

Participants receiving or considering treatment with Tysabri® (natalizumab).

Tysabri® (natalizumab)

Intervention Type DRUG

Prescribed according to the TYSABRI Outreach: United Commitment to Health (TOUCH) Prescribing Program

Interventions

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Tysabri® (natalizumab)

Prescribed according to the TYSABRI Outreach: United Commitment to Health (TOUCH) Prescribing Program

Intervention Type DRUG

Other Intervention Names

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natalizumab BG0002

Eligibility Criteria

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Inclusion Criteria

* Relapsing multiple sclerosis (MS) patients interested in or considering beginning treatment with Tysabri® (natalizumab).

Exclusion Criteria

* Patients participating in any other Tysabri® (natalizumab) clinical trial or study sponsored by Biogen Idec or Elan may not participate in this study.

Eligible Sex

ALL

Accepts Healthy Volunteers

No