Determine Impact of Multiple NAb Tests on Treatment Compared to Usual Care of MS Patients on High-dose IFN Therapy
- Conditions
- Multiple Sclerosis
- Interventions
- Procedure: NAbs testing
- Registration Number
- NCT00336557
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1230
- Willing to provide informed consent.
- Male or female, 18 years of age or older, with a diagnosis of MS.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Regularly Scheduled NAb Testing Arm NAbs testing 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method The nature of any therapy/management change in each arm 1 year Reason for change in therapy/management 1 year
Trial Locations
- Locations (49)
Neuro-Pain Medical Center
🇺🇸Fresno, California, United States
Fullerton Neurology and Headache Center
🇺🇸Fullerton, California, United States
East Bay Physicians Medical Group
🇺🇸Berkley, 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
🇺🇸Ft. Lauderdale, Florida, United States
Neurology Associates, PA
🇺🇸Maitland, Florida, United States
Collier Neurologic Specialitsts
🇺🇸Naples, 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
Central Carolina Neurology & Sleep
🇺🇸Salisbury, North Carolina, United States
Asheville Neurology Specialist, PA
🇺🇸Asheville, North Carolina, United States
NeuroCare Center
🇺🇸Canton, Ohio, United States
Michigan Neurology Associates
🇺🇸St Clair Shores, Michigan, United States
Mankato Clinic
🇺🇸Mankato, Minnesota, United States
Columbia Center for Neurology and MS
🇺🇸Columbia, Missouri, United States
Advanced Neurology Specialist
🇺🇸Great Falls, Montana, United States
St John's Mercy Medical Center
🇺🇸St Louis, Missouri, United States
Creighton University Department of Neurology
🇺🇸Bellvue, Nebraska, United States
Comprehensive MS Care Clinic at South Shore Neurology
🇺🇸Patchogue, New York, United States
Neurology Associates of Albany, P.C.
🇺🇸Albany, New York, United States
The Neuroscience Center of Northern NJ
🇺🇸Morristown, New Jersey, United States
NYU Hospital for Join Diseases, MS Center
🇺🇸New York, New York, United States
East Carolina Neurology
🇺🇸Greenville, North Carolina, United States
Rochester Multiple Sclerosis Center
🇺🇸Rochester, New York, United States
Neurology Specialists, Inc
🇺🇸Dayton, Ohio, United States
Alliance for Neuro Research, LLC Absher Neurology
🇺🇸Greenville, North Carolina, United States
Raleigh Neurology Associates
🇺🇸Raleigh, North Carolina, United States
Oak Clinic
🇺🇸Uniontown, Ohio, United States
Medford Neurological Clinic,Inc
🇺🇸Medford, Oregon, United States
North Shore Clinical Associates
🇺🇸Erie, Pennsylvania, United States
Abington Neurological Associates
🇺🇸Abington, Pennsylvania, United States
NeuroHealth, INC
🇺🇸Warwick, Rhode Island, United States
Neurology Associates of Monroe County
🇺🇸East Stroudsburg, Pennsylvania, United States
Central Texas Neurology
🇺🇸Round Rock, Texas, United States
Mid-South Physicians
🇺🇸Germantown, Tennessee, United States
Dean Health System
🇺🇸Madison, Wisconsin, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Phoenix Neurological Associates, LTD
🇺🇸Phoenix, Arizona, 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
Axiom Clinical Research of Florida
🇺🇸Tampa, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
University of California, Davis
🇺🇸Sacramento, California, United States