JC-Virus (JCV) Antibody Program

Multiple Sclerosis Clinical Trial

— STRATIFY-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01070823
• Other study ID #: 101JC401
• Status: Completed
• Phase: N/A
• First received: February 17, 2010
• Last updated: October 4, 2016
• Start date: March 2010
• Est. completion date: June 2012

Study information

• Verified date: October 2016
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1096
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Tysabri® (natalizumab)
Prescribed according to the TYSABRI Outreach: United Commitment to Health (TOUCH) Prescribing Program

Locations

Country	Name	City	State
United States	Research Site	Atlanta	Georgia
United States	Research Site	Aurora	Colorado
United States	Research Site	Barrington	Illinois
United States	Research Site	Brighton	Massachusetts
United States	Research Site	Cullman	Georgia
United States	Research Site	Farmington Hills	Michigan
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	Portland	Oregon
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Round Rock	Texas
United States	Research Site	Salt Lake City	Utah

Sponsors (3)

Lead Sponsor	Collaborator
Biogen	Elan Pharmaceuticals, United BioSource Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of serum anti-JC virus (JCV) antibody	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.	Day 1	No
Primary	Number of participants with a false negative test	Confirm the false negative rate for serum anti-JCV antibody [assay].	Day 1	No
Secondary	Changes in JCV antibody status over time		Every 6 months for 2 Years	No