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

Sponsor

Biogen (Industry)

Overall Status

Completed

CT.gov ID

NCT02159573

Collaborator

(none)

530

Enrollment

Locations

Duration (Months)

12.3

Patients Per Site

Patients Per Site Per Month

Study Details

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	Phase
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

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 :

Jul 1, 2014

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Jan 1, 2015

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

ARR at 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 [12 months post initiation of treatment with Tecfidera]
The percent of participants with relapses requiring treatment with intravenous steroids [12 months post initiation of treatment with Tecfidera]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country
1	Research Site	Birmingham	Alabama	United States
2	Research Site	Cullman	Alabama	United States
3	Research Site	Gilbert	Arizona	United States
4	Research Site	Phoenix	Arizona	United States
5	Research Site	Aurora	Colorado	United States
6	Research Site	Centennial	Colorado	United States
7	Research Site	Washington	District of Columbia	United States
8	Research Site	Jacksonville Beach	Florida	United States
9	Research Site	Palm Bay	Florida	United States
10	Research Site	Tampa	Florida	United States
11	Research Site	Athens	Georgia	United States
12	Research Site	Atlanta	Georgia	United States
13	Research Site	Idaho Falls	Idaho	United States
14	Research Site	Chicago	Illinois	United States
15	Research Site	Peoria	Illinois	United States
16	Research Site	Baton Rouge	Louisiana	United States
17	Research Site	Glen Burnie	Maryland	United States
18	Research Site	Boston	Massachusetts	United States
19	Research Site	Farmington Hills	Michigan	United States
20	Research Site	Golden Valley	Minnesota	United States
21	Research Site	Lincoln	Nebraska	United States
22	Research Site	Teaneck	New Jersey	United States
23	Research Site	Amherst	New York	United States
24	Research Site	East Meadow	New York	United States
25	Research Site	New York	New York	United States
26	Research Site	Charlotte	North Carolina	United States
27	Research Site	Raleigh	North Carolina	United States
28	Research Site	Columbus	Ohio	United States
29	Research Site	Gahanna	Ohio	United States
30	Research Site	Uniontown	Ohio	United States
31	Research Site	Oklahoma City	Oklahoma	United States
32	Research Site	Portland	Oregon	United States
33	Research Site	Altoona	Pennsylvania	United States
34	Research Site	Pittsburgh	Pennsylvania	United States
35	Research Site	Nashville	Tennessee	United States
36	Research Site	Dallas	Texas	United States
37	Research Site	Salt Lake City	Utah	United States
38	Research Site	Newport News	Virginia	United States
39	Research Site	Norfolk	Virginia	United States
40	Research Site	Seattle	Washington	United States
41	Research Site	Spokane	Washington	United States
42	Research Site	Madison	Wisconsin	United States
43	Research Site	Milwaukee	Wisconsin	United States