Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif®
- Registration Number
- NCT02823951
- Lead Sponsor
- IMS HEALTH GmbH & Co. OHG
- Brief Summary
The purpose of this study is to evaluate the proportion of patients who demonstrate no medical need to discontinue therapy among DMT-naïve patients with relapsing forms of multiple sclerosis after 1 year of treatment with Rebif 44 mcg tiw or with Tecfidera 240 mg bid based on real-world data.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 479
- Diagnosis of Clinically Isolated Syndrome (CIS) or a relapse remitting multiple sclerosis (RRMS).
- Age between 18 - 55 years at the time of index.
- No evidence of prior disease modifying therapy for MS.
- 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.
- 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.
- Availability of clinical data in the patient's record for the full study observation period, as defined in the primary objective.
- Pregnant at any time during the study observation period.
- Presence of pre-existing medical conditions known to be associated with brain pathology (cerebrovascular and neurodegenerative diseases, presence of active alcohol or substance abuse).
- 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.).
- Phase III registrational trial patients
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Rebif - early discontinuation cohort - adverse events Rebif Treatment naive patients starting with Rebif, MRI scan available at baseline, discontinuation within the first treatment year due to adverse events Tecfidera - 1 year clinical cohort Tecfidera Treatment naive patients starting with Tecfidera, 1 year follow-up available, MRI scan available at baseline Rebif - 1 year MRI cohort Rebif Treatment naive patients starting with Rebif, 1 year follow-up available, MRI scan available at baseline and at 12 months Rebif - early discontinuation cohort - disease activity Rebif Treatment naive patients starting with Rebif, MRI scan available at baseline, discontinuation within the first treatment year due to disease activity Tecfidera - early discontinuation cohort - tolerability Tecfidera Treatment naive patients starting with Tecfidera, MRI scan available at baseline, discontinuation within the first treatment year due to tolerability Rebif - early discontinuation cohort - tolerability Rebif Treatment naive patients starting with Rebif, MRI scan available at baseline, discontinuation within the first treatment year due to tolerability Tecfidera - 1 year MRI cohort Tecfidera Treatment naive patients starting with Tecfidera, 1 year follow-up available, MRI scan available at baseline and at 12 months Tecfidera - early discontinuation cohort - disease activity Tecfidera Treatment naive patients starting with Tecfidera, MRI scan available at baseline, discontinuation within the first treatment year due to disease activity Rebif - 1 year clinical cohort Rebif Treatment naive patients starting with Rebif, 1 year follow-up available, MRI scan available at baseline Tecfidera - early discontinuation cohort - adverse events Tecfidera Treatment naive patients starting with Tecfidera, MRI scan available at baseline, discontinuation within the first treatment year due to adverse events
- Primary Outcome Measures
Name Time Method NEDA-2 12 months Number of patients who had no need to discontinue therapy within the first 12months after index date. Unit of measure is number of patients.
No medical need to discontinue therapy is reached if there are no relapses and no new lesions, and no enlarging lesions and the patient did not stop the index medication due to tolerability, adverse events or disease activity. If any of the above occurs, NEDA-2 is not reached.
- Secondary Outcome Measures
Name Time Method Neurological differences between two treatment groups 12 months Comparison of number of new lesions and number of enlarging lesions between the two treatment groups. Unit of measurement is number of each lesion type.
Proportion of individuals within each treatment group who discontinued, stratified by reason 12 months Proportion of individuals within each treatment group who discontinued treatment due
* to tolerability
* to adverse events
* to disease activity Unit of measurement is the share of patients who discontinued compared to total patients stratified by reason of discontinuation.Clinical differences between the two treatment groups 12 months Comparison of number of relapses between the two treatment groups.
Trial Locations
- Locations (23)
Savannah Neurology Specialists
🇺🇸Savannah, Georgia, United States
Northshore University
🇺🇸Evanston, Illinois, United States
Washington university
🇺🇸Saint Louis, Missouri, United States
Lahey Clinic
🇺🇸Burlington, Massachusetts, United States
Minneapolis Clinic of Neurology
🇺🇸Golden Valley, Minnesota, 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
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
Centre Hospitalier de l'Universite de Montreal
🇨🇦Montréal, Quebec, Canada
MultiCare Health System
🇺🇸Tacoma, Washington, United States
Neuroscience Group
🇺🇸Neenah, Wisconsin, United States
Colorado Springs Neurological Associates
🇺🇸Colorado Springs, Colorado, United States
OSF Multi-specialty Group d/b/a Illinois Neurological Institute
🇺🇸Peoria, Illinois, United States
Onsite Clinical Solutions
🇺🇸Charlotte, North Carolina, United States
University of Nebraska Medical Center
🇺🇸Lincoln, Nebraska, United States
St Elizabeths/ Dragonfly Research
🇺🇸Brighton, Massachusetts, United States
University of Vermont
🇺🇸Burlington, Vermont, United States
Alabama Neurology Associates
🇺🇸Birmingham, Alabama, 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
Blacksburg Neurology
🇺🇸Christiansburg, Virginia, United States