Determine Impact of Multiple NAb Tests on Treatment Compared to Usual Care of MS Patients on High-dose IFN Therapy
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
1 other identifier
observational
1,230
1 country
49
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2006
Typical duration for all trials
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2006
CompletedFirst Posted
Study publicly available on registry
June 13, 2006
CompletedStudy Start
First participant enrolled
July 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedOctober 30, 2013
October 1, 2013
2.8 years
June 12, 2006
October 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (2)
The nature of any therapy/management change in each arm
1 year
Reason for change in therapy/management
1 year
Study Arms (2)
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.
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
blood drawn for a Binding Antibody (BAb) and Neutralizing Antibody (NAb) test.
Eligibility Criteria
Subjects who have been on high-dose Interferon (IFN) for 1 to 4 years
You may qualify if:
- Willing to provide informed consent.
- Male or female, 18 years of age or older, with a diagnosis of MS.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (49)
Phoenix Neurological Associates, LTD
Phoenix, Arizona, 85006, United States
East Bay Physicians Medical Group
Berkley, California, 94705, United States
Neuro-Pain Medical Center
Fresno, California, 93710, United States
Fullerton Neurology and Headache Center
Fullerton, California, 92835, United States
University of Southern California
Los Angeles, California, 90033, United States
University of California, Davis
Sacramento, California, 95817, United States
Neurology Clinic of Marin
San Anselmo, California, 94960, United States
Colorado Springs Neurological Associates, PC
Colorado Springs, Colorado, 80910, United States
Colorado Neurosurgery
Engelwood, Colorado, 80113, United States
The Emery Neuroscience Center
Fort Lauderdale, Florida, 33308, United States
Neurology Associates, PA
Maitland, Florida, 32751, United States
Collier Neurologic Specialitsts
Naples, Florida, 34102, United States
Axiom Clinical Research of Florida
Tampa, Florida, 33609, United States
University of South Florida
Tampa, Florida, 33612, United States
Medical College of Georgia Augusta MS Center
Augusta, Georgia, 30912, United States
Carle Clinic Association
Urbana, Illinois, 61801, United States
Neurology Associates
Hopedale, Massachusetts, 01747, United States
Lahey Clinic
Lexinton, Massachusetts, 02124, United States
South Shores Neurology Associates, INC
South Weymouth, Massachusetts, 02190, United States
Michigan Neurology Associates
Saint Clair Shores, Michigan, 48080, United States
Mankato Clinic
Mankato, Minnesota, 56001, United States
Columbia Center for Neurology and MS
Columbia, Missouri, 65201, United States
St John's Mercy Medical Center
St Louis, Missouri, 63141, United States
Advanced Neurology Specialist
Great Falls, Montana, 59405, United States
Creighton University Department of Neurology
Bellvue, Nebraska, 68123, United States
The Neuroscience Center of Northern NJ
Morristown, New Jersey, 07960, United States
Neurology Associates of Albany, P.C.
Albany, New York, 12208, United States
NYU Hospital for Join Diseases, MS Center
New York, New York, 10003, United States
Comprehensive MS Care Clinic at South Shore Neurology
Patchogue, New York, 11772, United States
Rochester Multiple Sclerosis Center
Rochester, New York, 14642, United States
Asheville Neurology Specialist, PA
Asheville, North Carolina, 28806, United States
East Carolina Neurology
Greenville, North Carolina, 27834, United States
Alliance for Neuro Research, LLC Absher Neurology
Greenville, North Carolina, 29615, United States
Raleigh Neurology Associates
Raleigh, North Carolina, 27607, United States
Central Carolina Neurology & Sleep
Salisbury, North Carolina, 28144, United States
NeuroCare Center
Canton, Ohio, 44718, United States
Neurology Specialists, Inc
Dayton, Ohio, 45408, United States
Oak Clinic
Uniontown, Ohio, 44685, United States
Medford Neurological Clinic,Inc
Medford, Oregon, 97504, United States
Abington Neurological Associates
Abington, Pennsylvania, 19001, United States
Neurology Associates of Monroe County
East Stroudsburg, Pennsylvania, 18301, United States
North Shore Clinical Associates
Erie, Pennsylvania, 16507, United States
NeuroHealth, INC
Warwick, Rhode Island, 02886, United States
Mid-South Physicians
Germantown, Tennessee, 38138, United States
Central Texas Neurology
Round Rock, Texas, 78681, United States
Neurology Center of San Antonio, P.A.
San Antonio, Texas, 78212, United States
Neurology Center of San Antonio
San Antonio, Texas, 78232, United States
Rocky Mountain Multiple Sclerosis Clinic
Salt Lake City, Utah, 84103, United States
Dean Health System
Madison, Wisconsin, 53715, United States
Biospecimen
blood drawn for a Binding Antibody (BAb) and Neutralizing Antibody (NAb) test.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Stephen Glenski, PharmD
Teva Neuroscience, Inc.
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2006
First Posted
June 13, 2006
Study Start
July 1, 2006
Primary Completion
April 1, 2009
Study Completion
July 1, 2009
Last Updated
October 30, 2013
Record last verified: 2013-10