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

June 4, 2016 updated by: Biogen

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

530

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Research Site
      • Cullman, Alabama, United States
        • Research Site
    • Arizona
      • Gilbert, Arizona, United States
        • Research Site
      • Phoenix, Arizona, United States
        • Research Site
    • Colorado
      • Aurora, Colorado, United States
        • Research Site
      • Centennial, Colorado, United States
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, United States
        • Research Site
    • Florida
      • Jacksonville Beach, Florida, United States
        • Research Site
      • Palm Bay, Florida, United States
        • Research Site
      • Tampa, Florida, United States
        • Research Site
    • Georgia
      • Athens, Georgia, United States
        • Research Site
      • Atlanta, Georgia, United States
        • Research Site
    • Idaho
      • Idaho Falls, Idaho, United States
        • Research Site
    • Illinois
      • Chicago, Illinois, United States
        • Research Site
      • Peoria, Illinois, United States
        • Research Site
    • Louisiana
      • Baton Rouge, Louisiana, United States
        • Research Site
    • Maryland
      • Glen Burnie, Maryland, United States
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • Research Site
    • Michigan
      • Farmington Hills, Michigan, United States
        • Research Site
    • Minnesota
      • Golden Valley, Minnesota, United States
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, United States
        • Research Site
    • New Jersey
      • Teaneck, New Jersey, United States
        • Research Site
    • New York
      • Amherst, New York, United States
        • Research Site
      • East Meadow, New York, United States
        • Research Site
      • New York, New York, United States
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States
        • Research Site
      • Raleigh, North Carolina, United States
        • Research Site
    • Ohio
      • Columbus, Ohio, United States
        • Research Site
      • Gahanna, Ohio, United States
        • Research Site
      • Uniontown, Ohio, United States
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • Oregon
      • Portland, Oregon, United States
        • Research Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States
        • Research Site
      • Pittsburgh, Pennsylvania, United States
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States
        • Research Site
    • Texas
      • Dallas, Texas, United States
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States
        • Research Site
    • Virginia
      • Newport News, Virginia, United States
        • Research Site
      • Norfolk, Virginia, United States
        • Research Site
    • Washington
      • Seattle, Washington, United States
        • Research Site
      • Spokane, Washington, United States
        • Research Site
    • Wisconsin
      • Madison, Wisconsin, United States
        • Research Site
      • Milwaukee, Wisconsin, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months post initiation of treatment with Tecfidera

Secondary Outcome Measures

Outcome Measure
Time Frame
ARR at 12 months post-initiation of treatment with Tecfidera
Time Frame: 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
Time Frame: 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
Time Frame: 12 months post initiation of treatment with Tecfidera
12 months post initiation of treatment with Tecfidera

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

May 19, 2014

First Submitted That Met QC Criteria

June 6, 2014

First Posted (ESTIMATE)

June 10, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

June 7, 2016

Last Update Submitted That Met QC Criteria

June 4, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 109MS412
  • US-BGT-13-10564 (OTHER: BIIB GMA)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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