Determine Impact of Multiple NAb Tests on Treatment Compared to Usual Care of MS Patients on High-dose IFN Therapy

October 29, 2013 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

A Randomized, Controlled, Open-Label Parallel Group Study to Evaluate the Effect of Regularly Scheduled Neutralizing Antibody Testing on Treatment Patterns Versus Usual Care in High-Dose Interferon Treated Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1230

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Phoenix Neurological Associates, LTD
    • California
      • Berkley, California, United States, 94705
        • East Bay Physicians Medical Group
      • Fresno, California, United States, 93710
        • Neuro-Pain Medical Center
      • Fullerton, California, United States, 92835
        • Fullerton Neurology and Headache Center
      • Los Angeles, California, United States, 90033
        • University of Southern California
      • Sacramento, California, United States, 95817
        • University of California, Davis
      • San Anselmo, California, United States, 94960
        • Neurology Clinic of Marin
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Colorado Springs Neurological Associates, PC
      • Engelwood, Colorado, United States, 80113
        • Colorado Neurosurgery
    • Florida
      • Ft. Lauderdale, Florida, United States, 33308
        • The Emery Neuroscience Center
      • Maitland, Florida, United States, 32751
        • Neurology Associates, PA
      • Naples, Florida, United States, 34102
        • Collier Neurologic Specialitsts
      • Tampa, Florida, United States, 33609
        • Axiom Clinical Research of Florida
      • Tampa, Florida, United States, 33612
        • University of South Florida
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Medical College of Georgia Augusta MS Center
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Carle Clinic Association
    • Massachusetts
      • Hopedale, Massachusetts, United States, 01747
        • Neurology Associates
      • Lexinton, Massachusetts, United States, 02124
        • Lahey Clinic
      • South Weymouth, Massachusetts, United States, 02190
        • South Shores Neurology Associates, INC
    • Michigan
      • St Clair Shores, Michigan, United States, 48080
        • Michigan Neurology Associates
    • Minnesota
      • Mankato, Minnesota, United States, 56001
        • Mankato Clinic
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Columbia Center for Neurology and MS
      • St Louis, Missouri, United States, 63141
        • St John's Mercy Medical Center
    • Montana
      • Great Falls, Montana, United States, 59405
        • Advanced Neurology Specialist
    • Nebraska
      • Bellvue, Nebraska, United States, 68123
        • Creighton University Department of Neurology
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • The Neuroscience Center of Northern NJ
    • New York
      • Albany, New York, United States, 12208
        • Neurology Associates of Albany, P.C.
      • New York, New York, United States, 10003
        • NYU Hospital for Join Diseases, MS Center
      • Patchogue, New York, United States, 11772
        • Comprehensive MS Care Clinic at South Shore Neurology
      • Rochester, New York, United States, 14642
        • Rochester Multiple Sclerosis Center
    • North Carolina
      • Asheville, North Carolina, United States, 28806
        • Asheville Neurology Specialist, PA
      • Greenville, North Carolina, United States, 27834
        • East Carolina Neurology
      • Greenville, North Carolina, United States, 29615
        • Alliance for Neuro Research, LLC Absher Neurology
      • Raleigh, North Carolina, United States, 27607
        • Raleigh Neurology Associates
      • Salisbury, North Carolina, United States, 28144
        • Central Carolina Neurology & Sleep
    • Ohio
      • Canton, Ohio, United States, 44718
        • NeuroCare Center
      • Dayton, Ohio, United States, 45408
        • Neurology Specialists, Inc
      • Uniontown, Ohio, United States, 44685
        • Oak Clinic
    • Oregon
      • Medford, Oregon, United States, 97504
        • Medford Neurological Clinic,Inc
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Neurological Associates
      • East Stroudsburg, Pennsylvania, United States, 18301
        • Neurology Associates of Monroe County
      • Erie, Pennsylvania, United States, 16507
        • North Shore Clinical Associates
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • NeuroHealth, INC
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Mid-South Physicians
    • Texas
      • Round Rock, Texas, United States, 78681
        • Central Texas Neurology
      • San Antonio, Texas, United States, 78212
        • Neurology Center of San Antonio, P.A.
      • San Antonio, Texas, United States, 78232
        • Neurology Center of San Antonio
    • Utah
      • Salt Lake City, Utah, United States, 84103
        • Rocky Mountain Multiple Sclerosis Clinic
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • Dean Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
blood drawn for a Binding Antibody (BAb) and Neutralizing Antibody (NAb) test.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

  • Study Chair: Stephen Glenski, PharmD, Teva Neuroscience, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (ACTUAL)

April 1, 2009

Study Completion (ACTUAL)

July 1, 2009

Study Registration Dates

First Submitted

June 12, 2006

First Submitted That Met QC Criteria

June 12, 2006

First Posted (ESTIMATE)

June 13, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

October 30, 2013

Last Update Submitted That Met QC Criteria

October 29, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PM028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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