Determine Impact of Multiple NAb Tests on Treatment Compa... | NCT00336557

Status Module

Record Verification Date

Oct 2013

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

Jul 2006

Primary Completion Date

Apr 2009Actual

Completion Date

Jul 2009Actual

First Submitted Date

Jun 12, 2006

First Submission Date that Met QC Criteria

Jun 12, 2006

First Posted Date

Jun 13, 2006Estimated

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 29, 2013

Last Update Posted Date

Oct 30, 2013Estimated

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

An observational study to determine the impact of multiple neutralizing antibody (NAb) tests on treatment patterns compared to the usual care of MS patients receiving high-dose IFN therapy.

Detailed Description

An observational study to determine the impact of multiple neutralizing antibody (NAb) tests on treatment patterns compared to the usual care of MS patients receiving high-dose IFN therapy.

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

1,230Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Regularly Scheduled NAb Testing Arm		Subjects will be scheduled for 5 study visits over the course of 12 months and any NAbs test results will be available to the investigator during the study.	Procedure: NAbs testing
Usual Care Arm		Subjects will be scheduled for 2 study visits over the course of 12 months and any NAbs test results will be unknown by the investigator until the conclusion of the subject's study participation.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NAbs testing	Procedure	blood drawn for a Binding Antibody (BAb) and Neutralizing Antibody (NAb) test.	Regularly Scheduled NAb Testing Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of subjects whose high dose IFN therapy had changed in the regularly scheduled NAbs testing arm versus the Usual Care Arm		1 year

Secondary Outcomes

Measure	Description	Time Frame
The nature of any therapy/management change in each arm		1 year
Reason for change in therapy/management		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Willing to provide informed consent.
Male or female, 18 years of age or older, with a diagnosis of MS.

Exclusion Criteria:

Has been on oral or parenteral corticosteroid therapy within the two weeks prior to the Baseline Visit.
Has been treated with immunoglobulins (IgG) or plasmapheresis within the last six months.
Has any condition which the investigator or nurse feels may interfere with participation in the study or with assessments for the full duration of the study.
Previously participated in this study.
Has received an experimental drug in the last thirty (30) days.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects who have been on high-dose Interferon (IFN) for 1 to 4 years

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephen Glenski, PharmD	Teva Neuroscience, Inc.	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Phoenix Neurological Associates, LTD		Phoenix	Arizona	85006	United States
East Bay Physicians Medical Group

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases