Determine Impact of Multiple NAb Tests on Treatment Compared to Usual Care of MS Patients on High-dose IFN Therapy
NCT ID: NCT00336557
Last Updated: 2013-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1230 participants
OBSERVATIONAL
2006-07-31
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
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.
No interventions assigned to this group
Interventions
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NAbs testing
blood drawn for a Binding Antibody (BAb) and Neutralizing Antibody (NAb) test.
Eligibility Criteria
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Inclusion Criteria
* Male or female, 18 years of age or older, with a diagnosis of MS.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Stephen Glenski, PharmD
Role: STUDY_CHAIR
Teva Neuroscience, Inc.
Locations
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Phoenix Neurological Associates, LTD
Phoenix, Arizona, United States
East Bay Physicians Medical Group
Berkley, California, United States
Neuro-Pain Medical Center
Fresno, California, United States
Fullerton Neurology and Headache Center
Fullerton, California, United States
University of Southern California
Los Angeles, California, United States
University of California, Davis
Sacramento, California, United States
Neurology Clinic of Marin
San Anselmo, California, United States
Colorado Springs Neurological Associates, PC
Colorado Springs, Colorado, United States
Colorado Neurosurgery
Engelwood, Colorado, United States
The Emery Neuroscience Center
Fort Lauderdale, Florida, United States
Neurology Associates, PA
Maitland, Florida, United States
Collier Neurologic Specialitsts
Naples, Florida, United States
Axiom Clinical Research of Florida
Tampa, Florida, United States
University of South Florida
Tampa, Florida, United States
Medical College of Georgia Augusta MS Center
Augusta, Georgia, United States
Carle Clinic Association
Urbana, Illinois, United States
Neurology Associates
Hopedale, Massachusetts, United States
Lahey Clinic
Lexinton, Massachusetts, United States
South Shores Neurology Associates, INC
South Weymouth, Massachusetts, United States
Michigan Neurology Associates
Saint Clair Shores, Michigan, United States
Mankato Clinic
Mankato, Minnesota, United States
Columbia Center for Neurology and MS
Columbia, Missouri, United States
St John's Mercy Medical Center
St Louis, Missouri, United States
Advanced Neurology Specialist
Great Falls, Montana, United States
Creighton University Department of Neurology
Bellvue, Nebraska, United States
The Neuroscience Center of Northern NJ
Morristown, New Jersey, United States
Neurology Associates of Albany, P.C.
Albany, New York, United States
NYU Hospital for Join Diseases, MS Center
New York, New York, United States
Comprehensive MS Care Clinic at South Shore Neurology
Patchogue, New York, United States
Rochester Multiple Sclerosis Center
Rochester, New York, United States
Asheville Neurology Specialist, PA
Asheville, North Carolina, United States
East Carolina Neurology
Greenville, North Carolina, United States
Alliance for Neuro Research, LLC Absher Neurology
Greenville, North Carolina, United States
Raleigh Neurology Associates
Raleigh, North Carolina, United States
Central Carolina Neurology & Sleep
Salisbury, North Carolina, United States
NeuroCare Center
Canton, Ohio, United States
Neurology Specialists, Inc
Dayton, Ohio, United States
Oak Clinic
Uniontown, Ohio, United States
Medford Neurological Clinic,Inc
Medford, Oregon, United States
Abington Neurological Associates
Abington, Pennsylvania, United States
Neurology Associates of Monroe County
East Stroudsburg, Pennsylvania, United States
North Shore Clinical Associates
Erie, Pennsylvania, United States
NeuroHealth, INC
Warwick, Rhode Island, United States
Mid-South Physicians
Germantown, Tennessee, United States
Central Texas Neurology
Round Rock, Texas, United States
Neurology Center of San Antonio, P.A.
San Antonio, Texas, United States
Neurology Center of San Antonio
San Antonio, Texas, United States
Rocky Mountain Multiple Sclerosis Clinic
Salt Lake City, Utah, United States
Dean Health System
Madison, Wisconsin, United States
Countries
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Other Identifiers
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PM028
Identifier Type: -
Identifier Source: org_study_id
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