Dimethyl Fumarate (DMF) Observational Study

Multiple Sclerosis Clinical Trial

— ESTEEM  

Official title:

A Multicenter, Global, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Tecfidera™ (Dimethyl Fumarate) When Used in Routine Medical Practice in the Treatment of Multiple Sclerosis (ESTEEM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02047097
• Other study ID #: 109MS401
• Status: Completed
• Start date: November 19, 2013
• Est. completion date: October 31, 2022

Study information

• Verified date: May 2023
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The primary objective of the study is to determine the incidence, type, and pattern of serious adverse events (SAEs), including but not limited to infections (including opportunistic infections), hepatic events, malignancies, and renal events, and of adverse events (AEs) leading to treatment discontinuation in patients with MS treated with dimethyl fumarate (DMF). Secondary objectives of this study in this population are as follows: To determine dimethyl fumarate (DMF) prescription and utilization patterns in routine clinical practice in patients with multiple sclerosis (MS); To assess the effectiveness of dimethyl fumarate (DMF) on multiple sclerosis (MS) disease activity and disability progression in routine clinical practice as determined by the Expanded Disability Status Scale (EDSS) score and multiple sclerosis (MS) relapse information; and To assess the effect of dimethyl fumarate (DMF) on health-related quality of life, healthcare resource consumption, and work productivity.

Description:

Patients aged 12 to under 18 may be included where enrollment of pediatric patients in this study is considered observational and is permissible by local regulations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5487
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Patients with multiple sclerosis (MS) who are newly initiating treatment with dimethyl fumarate (DMF) under routine clinical care are eligible to participate in the study.

Key Exclusion Criteria:

• Patients with previous exposure to dimethyl fumarate (DMF), Fumaderm (fumaric acid esters), or compounded fumarates.

• Patients participating in other clinical studies.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• dimethyl fumarate
Provided under routine clinical care

Locations

Country	Name	City	State
Argentina	Research Site	Ciudad Autonoma Buenos Aires	Buenos Aires
Argentina	Research Site	Ciudad Autonoma Buenos Aires
Argentina	Research Site	Ciudad Autonoma Buenos Aires
Argentina	Research Site	Ciudad Autonoma Buenos Aires
Argentina	Research Site	Ciudad Autonoma Buenos Aires
Argentina	Research Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Research Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Research Site	Cordoba
Argentina	Research Site	Cordoba
Argentina	Research Site	Guaymallén
Argentina	Research Site	Mendoza
Argentina	Research Site	Rosario	Santa Fe
Argentina	Research Site	Rosario	Santa Fe
Argentina	Research Site	Salta
Argentina	Research Site	San Juan
Argentina	Research Site	San Miguel de Tucuman	Tucuman
Argentina	Research Site	Santiago del Estero
Argentina	Research Site	Vicente Lopez	Buenos Aires
Australia	Research Site	Auchenflower	Queensland
Australia	Research Site	Bedford Park	South Australia
Australia	Research Site	Box Hill	Victoria
Australia	Research Site	Camperdown	New South Wales
Australia	Research Site	Clayton	Victoria
Australia	Research Site	Concord	New South Wales
Australia	Research Site	Geelong	Victoria
Australia	Research Site	Gold Coast	Queensland
Australia	Research Site	Heidelberg	Victoria
Australia	Research Site	Kent Town	South Australia
Australia	Research Site	Kogarah	New South Wales
Australia	Research Site	Liverpool	New South Wales
Australia	Research Site	Melbourne	Victoria
Australia	Research Site	Melbourne	Victoria
Australia	Research Site	Nedlands	Western Australia
Australia	Research Site	New Lambton Heights	New South Wales
Australia	Research Site	Parkville	Victoria
Australia	Research Site	Randwick	New South Wales
Australia	Research Site	St. Leonards	New South Wales
Australia	Research Site	Sydney	New South Wales
Australia	Research Site	Westmead	New South Wales
Austria	Research Site	Amstetten
Austria	Research Site	Salzburg
Austria	Research Site	Vienna
Austria	Research Site	Vienna
Canada	Research Site	Burnaby	British Columbia
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Cambridge	Ontario
Canada	Research Site	Gatineau	Quebec
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	London	Ontario
Canada	Research Site	Milton	Ontario
Canada	Research Site	Moncton	New Brunswick
Canada	Research Sites	Montreal	Quebec
Canada	Research Site	Montréal	Quebec
Canada	Research Site	Montréal	Quebec
Canada	Research Site	Regina	Saskatchewan
Canada	Research Site	Scarborough	Ontario
Canada	Research Site	Sydney	Nova Scotia
Canada	Research Site	Thunder Bay	Ontario
Canada	Research Site	Victoria	British Columbia
Czechia	Research Site	Brno
Czechia	Research Site	Hradec Kralove
Czechia	Research Site	Jihlava
Czechia	Research Site	Olomouc
Czechia	Research Site	Pardubice
Czechia	Research Site	Praha 10
Czechia	Research Site	Teplice
Denmark	Research Site	Aarhus C
Denmark	Research Site	Esbjerg
Denmark	Research Site	Glostrup
Denmark	Research Site	Odense C
Denmark	Research Site	Sønderborg
France	Research Site	Agen cedex 09	Lot Et Garonne
France	Research Site	Bron Cedex	Rhone
France	Research Site	Dax cedex	Landes
France	Research Site	Epinal cedex	Vosges
France	Research Site	Gonesse
France	Research Site	La Roche sur Yon	Vendee
France	Research Site	Montlucon	Allier
France	Research Site	Mulhouse Cedex	Haut Rhin
France	Research Site	Perpignan	Pyrenees Orientales
France	Research Site	Pringy cedex	Haute Savoie
France	Research Site	Rambouillet
France	Research Site	Rueil Malmaison	Hauts De Seine
France	Research Site	Toulouse cedex 9	Haute Garonne
Germany	Research Site	Aachen	Nordrhein Westfalen
Germany	Research Site	Aachen	Nordrhein Westfalen
Germany	Research Site	Alzenau	Bavaria
Germany	Research Site	Bad Honnef	Nordrhein Westfalen
Germany	Research Site	Bayreuth	Bayern
Germany	Research Site	Bergisch-Gladbach	Nordrhein Westfalen
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Bielefeld	Nordrhein Westfalen
Germany	Research Site	Bochum	Nordrhein Westfalen
Germany	Research Site	Bogen	Bayern
Germany	Research Site	Bonn	Nordrhein Westfalen
Germany	Research Site	Buchholz	Niedersachsen
Germany	Research Site	Butzbach	Hessen
Germany	Research Site	Chemnitz	Sachsen
Germany	Research Site	Duesseldorf	Nordrhein Westfalen
Germany	Research Site	Eisenach	Thueringen
Germany	Research Site	Eltville	Hessen
Germany	Research Site	Erbach	Hessen
Germany	Research Site	Erfurt	Thueringen
Germany	Research Site	Erlangen	Bayern
Germany	Research Site	Eschwege	Hessen
Germany	Research Site	Essen	Nordrhein Westfalen
Germany	Research Site	Frankenthal	Rheinland Pfalz
Germany	Research Site	Frankfurt	Hessen
Germany	Research Site	Frankfurt	Hessen
Germany	Research Site	Frankfurt	Hessen
Germany	Research Site	Freiburg	Baden Wuerttemberg
Germany	Research Site	Gelnhausen	Hessen
Germany	Research Site	Giessen	Hessen
Germany	Research Site	Gladenbach	Hessen
Germany	Research Site	Gorlitz	Sachsen
Germany	Research Site	Gottingen	Niedersachsen
Germany	Research Site	Hagen	Nordrhein Westfalen
Germany	Research Site	Halle	Sachsen Anhalt
Germany	Research Site	Hamburg
Germany	Research Site	Hamburg
Germany	Research Site	Heidelberg	Baden Wuerttemberg
Germany	Research Site	Heidenheim	Baden Wuerttemberg
Germany	Research Site	Jena	Thueringen
Germany	Research Site	Kandel	Rheinland Pfalz
Germany	Research Site	Kassel	Hessen
Germany	Research Site	Katzenelnbogen	Rheinland Pfalz
Germany	Research Site	Kiel	Schleswig Holstein
Germany	Research Site	Koeln	Nordrhein Westfalen
Germany	Research Site	Köln	Nordrhein Westfalen
Germany	Research Site	Ladenburg	Baden Wuerttemberg
Germany	Research Site	Landshut	Bayern
Germany	Research Site	Leipzig	Sachsen
Germany	Research Site	Leipzig	Sachsen
Germany	Research Site	Magdeburg	Sachsen Anhalt
Germany	Research Site	Mannheim	Baden Wuerttemberg
Germany	Research Site	Mannheim	Baden Wuerttemberg
Germany	Research Site	Muenchen	Bayern
Germany	Research Site	Neuburg	Bayern
Germany	Research Site	Neusäß
Germany	Research Site	Nuernberg	Bayern
Germany	Research Site	Nürnberg	Bayern
Germany	Research Site	Oldenburg	Niedersachsen
Germany	Research Site	Ravensburg	Baden Wuerttemberg
Germany	Research Site	Regensburg	Bayern
Germany	Research Site	Remscheid	Nordrhein Westfalen
Germany	Research Site	Rülzheim	Rheinland Pfalz
Germany	Research Site	Siegen	Nordrhein Westfalen
Germany	Research Site	Singen	Baden Wuerttemberg
Germany	Research Site	Sinsheim	Baden Wuerttemberg
Germany	Research Site	Stade	Niedersachsen
Germany	Research Site	Stuttgart	Baden Wuerttemberg
Germany	Research Site	Stuttgart	Baden Wuerttemberg
Germany	Research Site	Stuttgart	Baden Wuerttemberg
Germany	Research Site	Trier	Rheinland Pfalz
Germany	Research Site	Ulm	Baden Wuerttemberg
Germany	Research Site	Unterhaching	Bayern
Germany	Research Site	Wermsdorf	Sachsen
Germany	Research Site	Wiesbaden	Hessen
Germany	Research Site	Willich	Nordrhein Westfalen
Germany	Research Site	Wolfratshausen	Bayern
Germany	Research Site	Wuerzburg	Bayern
Germany	Research Site	Wuppertal	Nordrhein Westfalen
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Eger
Hungary	Research Site	Gyor
Hungary	Research Site	Miskolc
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Hungary	Research Site	Tatabanya
Hungary	Research Site	Zalaegerszeg
Ireland	Research Site	Dublin
Ireland	Research Site	Dublin
Italy	Research Site	Bari
Italy	Research Site	Bergamo
Italy	Research Site	Bologna
Italy	Research Site	Cagliari
Italy	Research Site	Catanzaro
Italy	Research Site	Fidenza	Parma
Italy	Research Site	Gallarate	Varese
Italy	Research Site	Genova
Italy	Research Site	Legnano	Milano
Italy	Research Site	Messina
Italy	Research Site	Milano
Italy	Research Site	Modena
Italy	Research Site	Montichiari	Brescia
Italy	Research Site	Napoli
Italy	Research Site	Orbassano	Torino
Italy	Research Site	Palermo
Italy	Research Site	Palermo
Italy	Research Site	Parma
Italy	Research Site	Pavia
Italy	Research Site	Perugia
Italy	Research Site	Pordenone
Italy	Research Site	Pozzilli	Isernia
Italy	Research Site	Reggio Emilia
Italy	Research Site	Roma
Italy	Research Site	Roma
Italy	Research Site	Roma
Italy	Research Site	Roma
Italy	Research Site	Torrette	Ancona
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Arnhem
Netherlands	Research Site	Breda
Netherlands	Research Site	Eindhoven
Netherlands	Research Site	Geldrop
Netherlands	Research Site	Geleen
Netherlands	Research Site	Hoorn
Netherlands	Research Site	Leeuwarden
Netherlands	Research Site	Leiden
Netherlands	Research Site	Nieuwegein
Netherlands	Research Site	Nijmegen
Netherlands	Research Site	Tilburg
Netherlands	Research Site	Venlo
New Zealand	Research Site	Christchurch
New Zealand	Research Site	Dunedin
New Zealand	Research Site	Hamilton
Norway	Research Site	Bodø
Norway	Research Site	Namsos
Poland	Research Site	Bialystok
Poland	Research Site	Bydgoszcz
Poland	Research Site	Gdansk
Poland	Research site	Glogow Malopolski
Poland	Research Site	Grudziadz
Poland	Research site	Katowice
Poland	Research Site	Katowice
Poland	Research Site	Konskie
Poland	Research site	Konstancin-Jeziorna
Poland	Research Site	Krakow
Poland	Research site	Krakow
Poland	Research Site	Lublin
Poland	Research Site	Ochojec	Katowice
Poland	Research Site	Olsztyn
Poland	Research Site	Poznan
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Poland	Research Site	Zabrze
Portugal	Research Site	Amadora
Portugal	Research Site	Braga
Portugal	Research Site	Guimarães
Portugal	Research Site	Matosinhos
Portugal	Research Site	Penafiel
Portugal	Research Site	Santarém
Portugal	Research Site	Viana do Castelo
Portugal	Research Site	Vila Nova de Gaia
Puerto Rico	Research Site	Guaynabo
Puerto Rico	Research Site	San Juan
Slovakia	Research Site	Banska Bystrica
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Bratislava
Slovakia	Research site	Martin
Slovakia	Research Site	Nitra
Slovakia	Research Site	Presov
Slovakia	Research Site	Ruzomberok
Slovakia	Research Site	Trencin
Slovakia	Research Site	Trnava
Spain	Research Site	Alzira	Valencia
Spain	Research Site	Avila
Spain	Research Site	Badalona	Barcelona
Spain	Research Site	Cádiz
Spain	Research Site	Gijon	Asturias
Spain	Research Site	Granada
Spain	Research Site	Huelva
Spain	Research Site	Jaén
Spain	Research Site	L'Hospitalet de Llobregat	Barcelona
Spain	Research Site	Madrid
Spain	Research Site	Murcia
Spain	Research Site	Palma de Mallorca	Baleares
Spain	Research Site	Pontevedra
Spain	Research Site	Santa Cruz de Tenerife	Tenerife
Spain	Research Site	Santander	Cantabria
Spain	Research Site	Santiago de Compostela	La Coruña
Switzerland	Research Site	Bern
Switzerland	Research Site	Lausanne
Switzerland	Research Site	Lugano
United Kingdom	Research Site	Basingstoke	Hampshire
United Kingdom	Research Site	Belfast
United Kingdom	Research Site	Birmingham	West Midlands
United Kingdom	Research Site	Bristol	Avon
United Kingdom	Research Site	Dundee	Tayside Region
United Kingdom	Research Site	Edinburgh	Lothian Region
United Kingdom	Research Site	Exeter	Devon
United Kingdom	Research Site	Glasgow	Strathclyde
United Kingdom	Research Site	Leeds	West Yorkshire
United Kingdom	Research Site	Leicester	Leicestershire
United Kingdom	Research Site	Liverpool	Merseyside
United Kingdom	Research Site	Newcastle upon Tyne	Tyne & Wear
United Kingdom	Research Site	Norwich	Norfolk
United Kingdom	Research Site	Nottingham	Nottinghamshire
United Kingdom	Research Site	Plymouth	Devon
United Kingdom	Research Site	Salford	Greater Manchester
United Kingdom	Research Site	Southampton	Hampshire
United Kingdom	Research Site	Swansea
United Kingdom	Research Site	Torquay	Devon
United States	Research Site	Abington	Pennsylvania
United States	Research Site	Albany	New York
United States	Research Site	Allentown	Pennsylvania
United States	Research Site	Ann Arbor	Michigan
United States	Research Site	Arlington	Texas
United States	Research Site	Asheville	North Carolina
United States	Research Site	Atlanta	Georgia
United States	Research Site	Atlanta	Georgia
United States	Research Sites	Atlanta	Georgia
United States	Research Site	Audubon	New Jersey
United States	Research Site	Augusta	Georgia
United States	Research Site	Aurora	Colorado
United States	Research Site	Baltimore	Maryland
United States	Research Site	Baltimore	Maryland
United States	Research Site	Bethesda	Maryland
United States	Research Site	Billings	Montana
United States	Research Site	Birmingham	Alabama
United States	Research Site	Bismarck	North Dakota
United States	Research Sites	Boca Raton	Florida
United States	Research Site	Boston	Massachusetts
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United States	Research Site	Canton	Ohio
United States	Research Site	Cedarhurst	New York
United States	Research Site	Centerville	Ohio
United States	Research Site	Charlotte	North Carolina
United States	Research Sites	Charlotte	North Carolina
United States	Research Site	Chicago	Illinois
United States	Research Site	Chicago	Illinois
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Cleveland	Ohio
United States	Research Site	Colleyville	Texas
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Columbia	South Carolina
United States	Research Site	Columbus	Ohio
United States	Research Site	Columbus	Georgia
United States	Research Site	Concord	New Hampshire
United States	Research Site	Cumberland	Maryland
United States	Research Site	Dallas	Texas
United States	Research Site	Dallas	Texas
United States	Research Site	Danbury	Connecticut
United States	Research Site	Denver	Colorado
United States	Research Site	Derby	Connecticut
United States	Research Site	Des Moines	Iowa
United States	Research Site	Des Moines	Iowa
United States	Research Site	Dover	Delaware
United States	Research Site	East Lansing	Michigan
United States	Research Site	East Meadow	New York
United States	Research Site	Edina	Minnesota
United States	Research Site	Elkhart	Indiana
United States	Research Site	Evanston	Illinois
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United States	Research Site	Flemington	New Jersey
United States	Research Site	Fort Collins	Colorado
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United States	Research Sites	Fullerton	California
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United States	Research Site	Gilbert	Arizona
United States	Research Site	Glen Burnie	Maryland
United States	Research Site	Great Falls	Montana
United States	Research Site	Green Bay	Wisconsin
United States	Research Site	Green Bay	Wisconsin
United States	Research Site	Green Bay	Wisconsin
United States	Research Site	Green Bay	Wisconsin
United States	Research Site	Greensboro	North Carolina
United States	Research Site	Greensburg	Pennsylvania
United States	Research Site	Greenville	South Carolina
United States	Research Site	Hackensack	New Jersey
United States	Research Site	Hammond	Louisiana
United States	Research Site	Hanford	California
United States	Research Site	Hartford	Connecticut
United States	Research Site	Henderson	Kentucky
United States	Research Site	Hendersonville	North Carolina
United States	Research Site	Herrin	Illinois
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United States	Research Site	Huntsville	Alabama
United States	Research Site	Indianapolis	Indiana
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United States	Research Site	Kingston	New York
United States	Research Site	Kirkland	Washington
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United States	Research Site	Knoxville	Tennessee
United States	Research Site	La Crosse	Wisconsin
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United States	Research Sites	Lighthouse Point	Florida
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United States	Research Sites	Lincoln	Nebraska
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United States	Research Site	Los Angeles	California
United States	Research Site	Louisville	Kentucky
United States	Research Site	Madison	Wisconsin
United States	Research Site	Maitland	Florida
United States	Research Site	Meadowbrook	Pennsylvania
United States	Research Site	Miami	Florida
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	Milwaukee	Wisconsin
United States	Research Sites	Minneapolis	Minnesota
United States	Research Site	Monroeville	Pennsylvania
United States	Research Site	Nashville	Tennessee
United States	Research Site	Nashville	Tennessee
United States	Research Site	Natrona Heights	Pennsylvania
United States	Research Site	Neenah	Wisconsin
United States	Research Site	New Brunswick	New Jersey
United States	Research Site	New Orleans	Louisiana
United States	Research Site	New York	New York
United States	Research Site	New York	New York
United States	Research Site	Newark	New Jersey
United States	Research Site	Newport Beach	California
United States	Research Site	Norfolk	Virginia
United States	Research Site	Norwich	Connecticut
United States	Research Site	Ocean Springs	Mississippi
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Overland Park	Kansas
United States	Research Site	Overland Park	Kansas
United States	Research Site	Patchogue	New York
United States	Research Site	Peoria	Illinois
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Phoenix	Arizona
United States	Research Site	Phoenix	Arizona
United States	Research Site	Phoenix	Arizona
United States	Research Site	Pinehurst	North Carolina
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Plainview	New York
United States	Research Site	Port Charlotte	Florida
United States	Research Site	Portland	Oregon
United States	Research Site	Portland	Oregon
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Richmond	Virginia
United States	Research Site	Rockport	Maine
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Saint Petersburg	Florida
United States	Research Site	Saint Petersburg	Florida
United States	Research Site	San Francisco	California
United States	Research Site	Santa Ana	California
United States	Research Site	Sarasota	Florida
United States	Research Site	Savannah	Georgia
United States	Research Site	Scottsdale	Arizona
United States	Research Site	Seattle	Washington
United States	Research Site	Spartanburg	South Carolina
United States	Research Site	Spokane	Washington
United States	Research Site	Springfield	Missouri
United States	Research Site	Stratford	New Jersey
United States	Research Site	Syracuse	New York
United States	Research Site	Syracuse	New York
United States	Research Site	Tacoma	Washington
United States	Research Site	Tacoma	Washington
United States	Research Site	Tampa	Florida
United States	Research Site	Toms River	New Jersey
United States	Research Site	Tucson	Arizona
United States	Research Site	Tulsa	Oklahoma
United States	Research Site	Virginia Beach	Virginia
United States	Research Site	Wahoo	Nebraska
United States	Research Site	Washington	District of Columbia
United States	Research Site	Washington	District of Columbia
United States	Research Site	Waterloo	Iowa
United States	Research Site	Waukesha	Wisconsin
United States	Research Site	Wellesley	Massachusetts
United States	Research Site	West Bloomfield	Michigan
United States	Research Site	West Long Branch	New Jersey
United States	Research Site	Wilmington	Delaware
United States	Research Sites	Wilmington	North Carolina
United States	Research Site	Winfield	Illinois
United States	Research Site	Winston-Salem	North Carolina
United States	Research Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Canada,  Czechia,  Denmark,  France,  Germany,  Hungary,  Ireland,  Italy,  Netherlands,  New Zealand,  Norway,  Poland,  Portugal,  Puerto Rico,  Slovakia,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of participants that experience Adverse Events (AEs) that lead to discontinuation of dimethyl fumarate (DMF)		Up to 5 years
Primary	The number of participants that experience Serious Adverse Events (SAEs)		Up to 5 years
Secondary	Duration of dimethyl fumarate (DMF) use		Up to 5 years
Secondary	dimethyl fumarate (DMF) dosing frequency		Up to 5 years
Secondary	Primary reasons for discontinuation of dimethyl fumarate (DMF) use		Up to 5 years
Secondary	Frequency of relapses over time		Up to 5 years
Secondary	Disease progression as measured by Expanded Disability Status Scale (EDSS) over time	The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist. Participants with confirmed progression of disability in EDSS physical functional system scores will be defined as those who meet one of the following criteria: an increase of = 1 point from baseline system score of = 1 or an increase of = 2 points from baseline system score of 0 in at least 2 physical functional systems, or an increase of = 2 points from baseline system score of = 1 or an increase of = 3 points from baseline system score of 0 in any 1 physical functional system. Worsening must be confirmed on a subsequent examination using the same criterion in the same functional system(s) at least 6 months later.	Up to 5 years
Secondary	Multiple Sclerosis Impact Scale-29 Items (MSIS-29) physical multiple sclerosis (MS) impact score	The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a patient-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a patient's perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health.	Up to 5 years
Secondary	Multiple Sclerosis Impact Scale-29 Items (MSIS-29) psychological multiple sclerosis (MS) impact score	The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a patient-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a patient's perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health.	Up to 5 years
Secondary	EuroQol-5 Dimensions (5 Level) (EQ-5D-5L) index score	Descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension.	Up to 5 years
Secondary	EuroQol Visual Analogue Scale (EQ VAS) (0-100 scale)	Standard vertical 20 cm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state (often referred to as page 3 of the EQ-5D questionnaire)	Up to 5 years
Secondary	Modified Fatigue Impact Scale-5 (MFIS-5) total score	MFIS-5 is a modified form of the Fatigue Impact Scale that consists of five questions that assess the impact of fatigue on physical, cognitive, and psychosocial functioning, with five response levels ranging from 0 ("Never") to 4 ("Almost always"). Total scores range from 0 to 20, with higher scores representing a greater impact of fatigue.	Up to 5 years
Secondary	Work Productivity and Activity Impairment questionnaire: Multiple Sclerosis, Version 2.0 (WPAI-MS) impairment percentages	The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.	Up to 5 years
Secondary	Health Care Resource Consumption Questionnaire	The Health Care Resource Consumption questionnaire is a survey that asks patients how MS affects their use of healthcare services and the impact it has on particular areas of their life (including number of hospitalizations [MS-related, non-MS related, relapse-related, resulting in steroid use], MS-related emergency room visits, MS-related neurologist visits, visits to other health care professionals for MS-related and other reasons).	Up to 5 years