Real-world Outcomes on Tecfidera (BG00012, Dimethyl Fumarate) Post-Tysabri (BG00002, Natalizumab)
STRATEGY
A Multicenter, Retrospective, Observational Study Evaluating Real-world Clinical Outcomes in Relapsing-remitting Multiple Sclerosis Patients Who Transition From Tysabri® (Natalizumab) to Tecfidera® (Dimethyl Fumarate)
2 other identifiers
observational
530
1 country
43
Brief Summary
The primary objective of the study is to evaluate relapse activity, as measured by the proportion of participants relapsed at 12 months, in participants with relapsing-remitting multiple sclerosis (RRMS) who transition from Tysabri (BG00002) to Tecfidera (BG00012) in the real-world setting. The secondary objective is to further evaluate relapse activity, defined as annualized relapse rate (ARR), hospitalization and intravenous corticosteroid use, during the first year of Tecfidera treatment following transition from Tysabri treatment.
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 2014
Shorter than P25 for all trials
43 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
May 19, 2014
CompletedFirst Posted
Study publicly available on registry
June 10, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedJune 7, 2016
June 1, 2016
6 months
May 19, 2014
June 4, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Kaplan-Meier Estimates for the Proportion of Participants relapsed at 12 months after initiation of treatment with Tecfidera
12 months post initiation of treatment with Tecfidera
Secondary Outcomes (3)
ARR at 12 months post-initiation of treatment with Tecfidera
12 months post initiation of treatment with Tecfidera
The percent of participants with MS-related hospitalization at 12 months post-initiation of treatment with Tecfidera
12 months post initiation of treatment with Tecfidera
The percent of participants with relapses requiring treatment with intravenous steroids
12 months post initiation of treatment with Tecfidera
Interventions
Administered as per routine clinical practice
Eligibility Criteria
Participants with a diagnosis of RRMS receiving at least 12 months of continuous treatment with Tysabri monotherapy prior to initiation of Tecfidera. Additionally, participants must have initiated treatment with Tecfidera at least 12 months prior to enrollment into the study.
You may qualify if:
- Diagnosis of RRMS per McDonald criteria
- Received at least 12 months of continuous treatment with Tysabri monotherapy prior to initiation of Tecfidera. Note: continuous treatment with Tysabri is defined as treatment uninterrupted by other disease-modifying treatment.
- Initiated treatment with Tecfidera at least 12 months prior to enrollment into the study
- Patient has sufficient available medical records for data abstraction to meet the objectives of the study
You may not qualify if:
- Diagnosed with a progressive form of multiple sclerosis (MS) (progressive-relapsing, primary progressive, secondary progressive)
- Received treatment with any of the following after discontinuation of Tysabri and before initiation of treatment with Tecfidera (i.e., during washout period): interferon-beta, glatiramer acetate, fingolimod, teriflunomide, rituximab, alemtuzumab, ocrelizumab or any investigational compound for the treatment of RRMS
- Received BG00012, or other formulations of dimethyl fumarate, or Fumaderm® or compounded fumarates at any time prior to initiation of treatment with Tecfidera
- History of progressive multifocal leukoencephalopathy (PML) while on Tysabri or within 6 months of discontinuing treatment with Tysabri
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (43)
Research Site
Birmingham, Alabama, United States
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Cullman, Alabama, United States
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Gilbert, Arizona, United States
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Phoenix, Arizona, United States
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Aurora, Colorado, United States
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Centennial, Colorado, United States
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Washington D.C., District of Columbia, United States
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Jacksonville Beach, Florida, United States
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Palm Bay, Florida, United States
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Tampa, Florida, United States
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Athens, Georgia, United States
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Atlanta, Georgia, United States
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Idaho Falls, Idaho, United States
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Chicago, Illinois, United States
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Peoria, Illinois, United States
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Baton Rouge, Louisiana, United States
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Glen Burnie, Maryland, United States
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Boston, Massachusetts, United States
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Farmington Hills, Michigan, United States
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Golden Valley, Minnesota, United States
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Lincoln, Nebraska, United States
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Teaneck, New Jersey, United States
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Amherst, New York, United States
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East Meadow, New York, United States
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New York, New York, United States
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Charlotte, North Carolina, United States
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Raleigh, North Carolina, United States
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Columbus, Ohio, United States
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Gahanna, Ohio, United States
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Uniontown, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Altoona, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Salt Lake City, Utah, United States
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Newport News, Virginia, United States
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Norfolk, Virginia, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
Related Publications (1)
Cohan SL, Moses H, Calkwood J, Tornatore C, LaGanke C, Smoot KE, Meka V, Okwuokenye M, Hotermans C, Mendoza JP, Mann MK, Meltzer LA. Clinical outcomes in patients with relapsing-remitting multiple sclerosis who switch from natalizumab to delayed-release dimethyl fumarate: A multicenter retrospective observational study (STRATEGY). Mult Scler Relat Disord. 2018 May;22:27-34. doi: 10.1016/j.msard.2018.02.028. Epub 2018 Feb 26.
PMID: 29524759DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2014
First Posted
June 10, 2014
Study Start
July 1, 2014
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
June 7, 2016
Record last verified: 2016-06