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

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

MedlinePlus Genetics related topics: Multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Formic acid Dimethyl fumarate Natalizumab

U.S. FDA Resources

Groups and Cohorts

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

Primary Outcome Measures :

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 :

ARR at 12 months post-initiation of treatment with Tecfidera [ Time Frame: 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 [ Time Frame: 12 months post initiation of treatment with Tecfidera ]
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

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
Research Site
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
Research Site
Columbus, Ohio, United States
Research Site
Gahanna, Ohio, United States
Research Site
Uniontown, Ohio, United States
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States
United States, Oregon
Research Site
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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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

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