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

Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsing-Remitting Multiple Sclerosis

Intervention: natalizumab (Biological); dimethyl fumarate (Drug)

Phase: N/A

Status: Completed

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Biogen

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.

Clinical Details

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 design: Observational Model: Cohort, Time Perspective: Retrospective

Primary outcome: Kaplan-Meier Estimates for the Proportion of Participants relapsed at 12 months after initiation of treatment with Tecfidera

Secondary outcome:

ARR at 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

The percent of participants with relapses requiring treatment with intravenous steroids

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Research Site, Birmingham, Alabama, United States

Research Site, Cullman, Alabama, United States

Research Site, Gilbert, Arizona, United States

Research Site, Phoenix, Arizona, United States

Research Site, Aurora, Colorado, United States

Research Site, Centennial, Colorado, United States

Research Site, Washington, District of Columbia, United States

Research Site, Jacksonville Beach, Florida, United States

Research Site, Palm Bay, Florida, United States

Research Site, Tampa, Florida, United States

Research Site, Athens, Georgia, United States

Research Site, Atlanta, Georgia, United States

Research Site, Idaho Falls, Idaho, United States

Research Site, Chicago, Illinois, United States

Research Site, Peoria, Illinois, United States

Research Site, Baton Rouge, Louisiana, United States

Research Site, Glen Burnie, Maryland, United States

Research Site, Boston, Massachusetts, United States

Research Site, Farmington Hills, Michigan, United States

Research Site, Golden Valley, Minnesota, United States

Research Site, Lincoln, Nebraska, United States

Research Site, Teaneck, New Jersey, United States

Research Site, Amherst, New York, United States

Research Site, East Meadow, New York, United States

Research Site, New York, New York, United States

Research Site, Charlotte, North Carolina, United States

Research Site, Raleigh, North Carolina, United States

Research Site, Columbus, Ohio, United States

Research Site, Gahanna, Ohio, United States

Research Site, Uniontown, Ohio, United States

Research Site, Oklahoma City, Oklahoma, United States

Research Site, Portland, Oregon, United States

Research Site, Altoona, Pennsylvania, United States

Research Site, Pittsburgh, Pennsylvania, United States

Research Site, Nashville, Tennessee, United States

Research Site, Dallas, Texas, United States

Research Site, Salt Lake City, Utah, United States

Research Site, Newport News, Virginia, United States

Research Site, Norfolk, Virginia, United States

Research Site, Seattle, Washington, United States

Research Site, Spokane, Washington, United States

Research Site, Madison, Wisconsin, United States

Research Site, Milwaukee, Wisconsin, United States

Additional Information

Starting date: July 2014
Last updated: April 30, 2015

Page last updated: August 23, 2015

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