Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif®
PROTRACT
1 other identifier
observational
479
2 countries
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2016
23 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
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 3, 2016
CompletedFirst Posted
Study publicly available on registry
July 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedMarch 1, 2018
February 1, 2018
1.2 years
March 3, 2016
February 28, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
NEDA-2
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.
12 months
Secondary Outcomes (3)
Clinical differences between the two treatment groups
12 months
Neurological differences between two treatment groups
12 months
Proportion of individuals within each treatment group who discontinued, stratified by reason
12 months
Study Arms (10)
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 - 1 year clinical cohort
Treatment naive patients starting with Rebif, 1 year follow-up available, MRI scan available at baseline
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 - 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 - 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
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 - 1 year clinical cohort
Treatment naive patients starting with Tecfidera, 1 year follow-up available, MRI scan available at baseline
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 - 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 - 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
Interventions
Eligibility Criteria
Treatment naive patients for Rebif or Tecfidera with at least 1 months follow-up data available from clinical chart review.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- IMS HEALTH GmbH & Co. OHGlead
- EMD Seronocollaborator
Study Sites (23)
Alabama Neurology Associates
Birmingham, Alabama, 35209, United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907, United States
Savannah Neurology Specialists
Savannah, Georgia, 31406, United States
Northshore University
Evanston, Illinois, 60201, United States
OSF Multi-specialty Group d/b/a Illinois Neurological Institute
Peoria, Illinois, 61637, United States
St Elizabeths/ Dragonfly Research
Brighton, Massachusetts, 02135, United States
Lahey Clinic
Burlington, Massachusetts, 01805, United States
Minneapolis Clinic of Neurology
Golden Valley, Minnesota, 55422, United States
Washington university
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Lincoln, Nebraska, 68588, United States
University of Buffalo Clinical and Translational research Center
Buffalo, New York, 14203, United States
Neurological Associates of Long Island
Lake Success, New York, 11042, United States
Onsite Clinical Solutions
Charlotte, North Carolina, 28277, United States
Raleigh Neurology Associates
Raleigh, North Carolina, 27607, United States
Dayton Center for Neurological Disorders
Centerville, Ohio, 45459, United States
Oak Clinic-Multiple Sclerosis
Uniontown, Ohio, 44685, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97228, United States
The university of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
University of Vermont
Burlington, Vermont, 05405, United States
Blacksburg Neurology
Christiansburg, Virginia, 24073, United States
MultiCare Health System
Tacoma, Washington, 98405, United States
Neuroscience Group
Neenah, Wisconsin, 54956, United States
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 0A9, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2016
First Posted
July 6, 2016
Study Start
February 1, 2016
Primary Completion
April 1, 2017
Study Completion
February 1, 2018
Last Updated
March 1, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share