Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif®
NCT ID: NCT02823951
Last Updated: 2018-03-01
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
479 participants
OBSERVATIONAL
2016-02-29
2018-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Rebif - 1 year MRI cohort
Treatment naive patients starting with Rebif, 1 year follow-up available, MRI scan available at baseline and at 12 months
Rebif
Rebif - 1 year clinical cohort
Treatment naive patients starting with Rebif, 1 year follow-up available, MRI scan available at baseline
Rebif
Rebif - early discontinuation cohort - tolerability
Treatment naive patients starting with Rebif, MRI scan available at baseline, discontinuation within the first treatment year due to tolerability
Rebif
Rebif - early discontinuation cohort - adverse events
Treatment naive patients starting with Rebif, MRI scan available at baseline, discontinuation within the first treatment year due to adverse events
Rebif
Rebif - early discontinuation cohort - disease activity
Treatment naive patients starting with Rebif, MRI scan available at baseline, discontinuation within the first treatment year due to disease activity
Rebif
Tecfidera - 1 year MRI cohort
Treatment naive patients starting with Tecfidera, 1 year follow-up available, MRI scan available at baseline and at 12 months
Tecfidera
Tecfidera - 1 year clinical cohort
Treatment naive patients starting with Tecfidera, 1 year follow-up available, MRI scan available at baseline
Tecfidera
Tecfidera - early discontinuation cohort - tolerability
Treatment naive patients starting with Tecfidera, MRI scan available at baseline, discontinuation within the first treatment year due to tolerability
Tecfidera
Tecfidera - early discontinuation cohort - adverse events
Treatment naive patients starting with Tecfidera, MRI scan available at baseline, discontinuation within the first treatment year due to adverse events
Tecfidera
Tecfidera - early discontinuation cohort - disease activity
Treatment naive patients starting with Tecfidera, MRI scan available at baseline, discontinuation within the first treatment year due to disease activity
Tecfidera
Interventions
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Rebif
Tecfidera
Eligibility Criteria
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Inclusion Criteria
2. Age between 18 - 55 years at the time of index.
3. No evidence of prior disease modifying therapy for MS.
4. Initiated treatment with either Rebif or Tecfidera at the time of index. Patient is considered to have initiated treatment if they took at least one dose. Treatment must have been initiated after the product was approved by the FDA.
5. Availability of a high quality baseline MRI brain scan, which must have occurred between 6 months prior to the index date to 2 weeks after the index date.
6. Availability of clinical data in the patient's record for the full study observation period, as defined in the primary objective.
Exclusion Criteria
2. Presence of pre-existing medical conditions known to be associated with brain pathology (cerebrovascular and neurodegenerative diseases, presence of active alcohol or substance abuse).
3. Patient discontinued initial therapy prior to completing 1 year of treatment due to a reason other than disease activity, tolerability, or safety (e.g. financial, convenience, preference, etc.).
4. Phase III registrational trial patients
18 Years
55 Years
ALL
No
Sponsors
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EMD Serono
INDUSTRY
IMS HEALTH GmbH & Co. OHG
INDUSTRY
Responsible Party
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Locations
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Alabama Neurology Associates
Birmingham, Alabama, United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, United States
Savannah Neurology Specialists
Savannah, Georgia, United States
Northshore University
Evanston, Illinois, United States
OSF Multi-specialty Group d/b/a Illinois Neurological Institute
Peoria, Illinois, United States
St Elizabeths/ Dragonfly Research
Brighton, Massachusetts, United States
Lahey Clinic
Burlington, Massachusetts, United States
Minneapolis Clinic of Neurology
Golden Valley, Minnesota, United States
Washington university
St Louis, Missouri, United States
University of Nebraska Medical Center
Lincoln, Nebraska, United States
University of Buffalo Clinical and Translational research Center
Buffalo, New York, United States
Neurological Associates of Long Island
Lake Success, New York, United States
Onsite Clinical Solutions
Charlotte, North Carolina, United States
Raleigh Neurology Associates
Raleigh, North Carolina, United States
Dayton Center for Neurological Disorders
Centerville, Ohio, United States
Oak Clinic-Multiple Sclerosis
Uniontown, Ohio, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
The university of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
University of Vermont
Burlington, Vermont, United States
Blacksburg Neurology
Christiansburg, Virginia, United States
MultiCare Health System
Tacoma, Washington, United States
Neuroscience Group
Neenah, Wisconsin, United States
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Countries
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Other Identifiers
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MS200136_0037
Identifier Type: -
Identifier Source: org_study_id
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