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Real-world Outcomes on Tecfidera (BG00012, Dimethyl Fumarate) Post-Tysabri (BG00002, Natalizumab) (STRATEGY)

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ClinicalTrials.gov Identifier: NCT02159573
Recruitment Status : Completed
First Posted : June 10, 2014
Last Update Posted : June 7, 2016
Sponsor:
Information provided by (Responsible Party):
Biogen

Study Description
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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.

Condition or disease Intervention/treatment
Relapsing-Remitting Multiple Sclerosis Biological: natalizumab Drug: dimethyl fumarate

Detailed Description:
The study period will consist of a single time point retrospective medical chart abstraction with no required study visits or procedures. Data collection for this study is expected to last up to approximately five months.
Study Design
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Study Type : Observational
Actual Enrollment : 530 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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)
Study Start Date : July 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Biological: natalizumab
    Administered as per routine clinical practice
    Other Names:
    • BG00002
    • Tysabri
  • Drug: dimethyl fumarate
    Administered as per routine clinical practice
    Other Names:
    • BG00012
    • Tecfidera
    • DMF

Outcome Measures
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Primary Outcome Measures :
  1. Kaplan-Meier Estimates for the Proportion of Participants relapsed at 12 months after initiation of treatment with Tecfidera [ Time Frame: 12 months post initiation of treatment with Tecfidera ]

Secondary Outcome Measures :
  1. ARR at 12 months post-initiation of treatment with Tecfidera [ Time Frame: 12 months post initiation of treatment with Tecfidera ]
  2. The percent of participants with MS-related hospitalization at 12 months post-initiation of treatment with Tecfidera [ Time Frame: 12 months post initiation of treatment with Tecfidera ]
  3. The percent of participants with relapses requiring treatment with intravenous steroids [ Time Frame: 12 months post initiation of treatment with Tecfidera ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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

NOTE: Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02159573


Locations
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United States, Alabama
Research Site
Birmingham, Alabama, United States
Research Site
Cullman, Alabama, United States
United States, Arizona
Research Site
Gilbert, Arizona, United States
Research Site
Phoenix, Arizona, United States
United States, Colorado
Research Site
Aurora, Colorado, United States
Research Site
Centennial, Colorado, United States
United States, District of Columbia
Research Site
Washington, District of Columbia, United States
United States, Florida
Research Site
Jacksonville Beach, Florida, United States
Research Site
Palm Bay, Florida, United States
Research Site
Tampa, Florida, United States
United States, Georgia
Research Site
Athens, Georgia, United States
Research Site
Atlanta, Georgia, United States
United States, Idaho
Research Site
Idaho Falls, Idaho, United States
United States, Illinois
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Chicago, Illinois, United States
Research Site
Peoria, Illinois, United States
United States, Louisiana
Research Site
Baton Rouge, Louisiana, United States
United States, Maryland
Research Site
Glen Burnie, Maryland, United States
United States, Massachusetts
Research Site
Boston, Massachusetts, United States
United States, Michigan
Research Site
Farmington Hills, Michigan, United States
United States, Minnesota
Research Site
Golden Valley, Minnesota, United States
United States, Nebraska
Research Site
Lincoln, Nebraska, United States
United States, New Jersey
Research Site
Teaneck, New Jersey, United States
United States, New York
Research Site
Amherst, New York, United States
Research Site
East Meadow, New York, United States
Research Site
New York, New York, United States
United States, North Carolina
Research Site
Charlotte, North Carolina, United States
Research Site
Raleigh, North Carolina, United States
United States, Ohio
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Columbus, Ohio, United States
Research Site
Gahanna, Ohio, United States
Research Site
Uniontown, Ohio, United States
United States, Oklahoma
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Oklahoma City, Oklahoma, United States
United States, Oregon
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Portland, Oregon, United States
United States, Pennsylvania
Research Site
Altoona, Pennsylvania, United States
Research Site
Pittsburgh, Pennsylvania, United States
United States, Tennessee
Research Site
Nashville, Tennessee, United States
United States, Texas
Research Site
Dallas, Texas, United States
United States, Utah
Research Site
Salt Lake City, Utah, United States
United States, Virginia
Research Site
Newport News, Virginia, United States
Research Site
Norfolk, Virginia, United States
United States, Washington
Research Site
Seattle, Washington, United States
Research Site
Spokane, Washington, United States
United States, Wisconsin
Research Site
Madison, Wisconsin, United States
Research Site
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02159573    
Other Study ID Numbers: 109MS412
US-BGT-13-10564 ( Other Identifier: BIIB GMA )
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: June 7, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
 Autoimmune Diseases
Immune System Diseases
Dimethyl Fumarate
Natalizumab
Immunologic Factors
Physiological Effects of Drugs
Dermatologic Agents
Immunosuppressive Agents