JC-Virus (JCV) Antibody Program | NCT01070823

Studies
JC-Virus (JCV) Antibody Program

NCT01070823

Sponsor

Biogen

Status

Completed

Last Update Posted

Oct 5, 2016Estimated

Enrollment

1,096Actual

Phase

Not provided

Conditions

Multiple Sclerosis

Interventions

Tysabri® (natalizumab)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Feb 17, 2010

First Submission Date that Met QC Criteria

Feb 17, 2010

First Posted Date

Feb 18, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 4, 2016

Last Update Posted Date

Oct 5, 2016Estimated

Name	Class
United BioSource, LLC	INDUSTRY
Elan Pharmaceuticals	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,096Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Relapsing Multiple Sclerosis		Participants receiving or considering treatment with Tysabri® (natalizumab).	Drug: Tysabri® (natalizumab)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tysabri® (natalizumab)	Drug	Prescribed according to the TYSABRI Outreach: United Commitment to Health (TOUCH) Prescribing Program	Relapsing Multiple Sclerosis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
Number of participants with a false negative test	Confirm the false negative rate for serum anti-JCV antibody [assay].	Day 1

Secondary Outcomes

Measure	Description	Time Frame
Changes in JCV antibody status over time		Every 6 months for 2 Years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with relapsing Multiple Sclerosis (MS) receiving commercial Tysabri® (natalizumab) and patients being considered for such treatment.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Director	Biogen	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Aurora	Colorado	80045	United States
Research Site

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069442	Natalizumab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided