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

Relapsing-Remitting Multiple Sclerosis Clinical Trial

— STRATEGY  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02159573
• Other study ID #: 109MS412
• Secondary ID: US-BGT-13-10564
• Status: Completed
• Phase: N/A
• First received: May 19, 2014
• Last updated: June 4, 2016
• Start date: July 2014
• Est. completion date: January 2015

Study information

• Verified date: June 2016
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 530
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-Remitting Multiple Sclerosis
• Sclerosis

Intervention

Biological:
• natalizumab
Administered as per routine clinical practice

Drug:
• dimethyl fumarate
Administered as per routine clinical practice

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	ARR at 12 months post-initiation of treatment with Tecfidera		12 months post initiation of treatment with Tecfidera	No
Secondary	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	No
Secondary	The percent of participants with relapses requiring treatment with intravenous steroids		12 months post initiation of treatment with Tecfidera	No