Skip to main content
OpenTrials
Completed

NCT Number: NCT01070823

JC-Virus (JCV) Antibody Program

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Aurora, Colorado, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

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

Key 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.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Tysabri® (natalizumab)

Drug

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

Other names: natalizumab, BG0002

Primary outcomes

  1. Prevalence of serum anti-JC virus (JCV) antibody

    Time frame: 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.

  2. Number of participants with a false negative test

    Time frame: Day 1

    Confirm the false negative rate for serum anti-JCV antibody [assay].

Secondary outcomes

  1. Changes in JCV antibody status over time

    Time frame: Every 6 months for 2 Years

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Collaborators

  • Elan Pharmaceuticals
  • United BioSource, LLC

Registry information

Official study title

JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri®: STRATIFY-1

Acronym: STRATIFY-1

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 18, 2010
Registry last updated
Oct 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.