Clinical trial NCT02047097: Dimethyl Fumarate (DMF) Observational Study
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2014-01-28
Enrollment: 5487
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing routine clinical care for Multiple Sclerosis.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The number of participants that experience Adverse Events (AEs) that lead to discontinuation of dimethyl fumarate (DMF)
timeFrame: Up to 5 years
measure: The number of participants that experience Serious Adverse Events (SAEs)
timeFrame: Up to 5 years
Secondary outcomes:
measure: Duration of dimethyl fumarate (DMF) use
timeFrame: Up to 5 years
measure: dimethyl fumarate (DMF) dosing frequency
timeFrame: Up to 5 years
measure: Primary reasons for discontinuation of dimethyl fumarate (DMF) use
timeFrame: Up to 5 years
measure: Frequency of relapses over time
timeFrame: Up to 5 years
measure: Disease progression as measured by Expanded Disability Status Scale (EDSS) over time
timeFrame: Up to 5 years
measure: Multiple Sclerosis Impact Scale-29 Items (MSIS-29) physical multiple sclerosis (MS) impact score
timeFrame: Up to 5 years
measure: Multiple Sclerosis Impact Scale-29 Items (MSIS-29) psychological multiple sclerosis (MS) impact score
timeFrame: Up to 5 years
measure: EuroQol-5 Dimensions (5 Level) (EQ-5D-5L) index score
timeFrame: Up to 5 years
measure: EuroQol Visual Analogue Scale (EQ VAS) (0-100 scale)
timeFrame: Up to 5 years
measure: Modified Fatigue Impact Scale-5 (MFIS-5) total score
timeFrame: Up to 5 years
measure: Work Productivity and Activity Impairment questionnaire: Multiple Sclerosis, Version 2.0 (WPAI-MS) impairment percentages
timeFrame: Up to 5 years
measure: Health Care Resource Consumption Questionnaire
timeFrame: Up to 5 years
Other outcomes:
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country: Germany
facility: Research Site
state: Nordrhein Westfalen
city: Bad Honnef
country: Germany
facility: Research Site
state: Nordrhein Westfalen
city: Bergisch-Gladbach
country: Germany
facility: Research Site
state: Nordrhein Westfalen
city: Bielefeld
country: Germany
facility: Research Site
state: Nordrhein Westfalen
city: Bochum
country: Germany
facility: Research Site
state: Nordrhein Westfalen
city: Bonn
country: Germany
facility: Research Site
state: Nordrhein Westfalen
city: Duesseldorf
country: Germany
facility: Research Site
state: Nordrhein Westfalen
city: Essen
country: Germany
facility: Research Site
state: Nordrhein Westfalen
city: Hagen
country: Germany
facility: Research Site
state: Nordrhein Westfalen
city: Koeln
country: Germany
facility: Research Site
state: Nordrhein Westfalen
city: Köln
country: Germany
facility: Research Site
state: Nordrhein Westfalen
city: Remscheid
country: Germany
facility: Research Site
state: Nordrhein Westfalen
city: Siegen
country: Germany
facility: Research Site
state: Nordrhein Westfalen
city: Willich
country: Germany
facility: Research Site
state: Nordrhein Westfalen
city: Wuppertal
country: Germany
facility: Research Site
state: Nordrhein Westfalen
city: Frankenthal
country: Germany
facility: Research Site
state: Rheinland Pfalz
city: Kandel
country: Germany
facility: Research Site
state: Rheinland Pfalz
city: Katzenelnbogen
country: Germany
facility: Research Site
state: Rheinland Pfalz
city: Rülzheim
country: Germany
facility: Research Site
state: Rheinland Pfalz
city: Trier
country: Germany
facility: Research Site
state: Rheinland Pfalz
city: Halle
country: Germany
facility: Research Site
state: Sachsen Anhalt
city: Magdeburg
country: Germany
facility: Research Site
state: Sachsen Anhalt
city: Chemnitz
country: Germany
facility: Research Site
state: Sachsen
city: Gorlitz
country: Germany
facility: Research Site
state: Sachsen
city: Leipzig
country: Germany
facility: Research Site
state: Sachsen
city: Leipzig
country: Germany
facility: Research Site
state: Sachsen
city: Wermsdorf
country: Germany
facility: Research Site
state: Sachsen
city: Kiel
country: Germany
facility: Research Site
state: Schleswig Holstein
city: Eisenach
country: Germany
facility: Research Site
state: Thueringen
city: Erfurt
country: Germany
facility: Research Site
state: Thueringen
city: Jena
country: Germany
facility: Research Site
state: Thueringen
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Neusäß
country: Germany
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Eger
country: Hungary
facility: Research Site
city: Gyor
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Tatabanya
country: Hungary
facility: Research Site
city: Zalaegerszeg
country: Hungary
facility: Research Site
city: Dublin
country: Ireland
facility: Research Site
city: Dublin
country: Ireland
facility: Research Site
city: Torrette
country: Italy
facility: Research Site
state: Ancona
city: Montichiari
country: Italy
facility: Research Site
state: Brescia
city: Pozzilli
country: Italy
facility: Research Site
state: Isernia
city: Legnano
country: Italy
facility: Research Site
state: Milano
city: Fidenza
country: Italy
facility: Research Site
state: Parma
city: Orbassano
country: Italy
facility: Research Site
state: Torino
city: Gallarate
country: Italy
facility: Research Site
state: Varese
city: Bari
country: Italy
facility: Research Site
city: Bergamo
country: Italy
facility: Research Site
city: Bologna
country: Italy
facility: Research Site
city: Cagliari
country: Italy
facility: Research Site
city: Catanzaro
country: Italy
facility: Research Site
city: Genova
country: Italy
facility: Research Site
city: Messina
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Modena
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Palermo
country: Italy
facility: Research Site
city: Palermo
country: Italy
facility: Research Site
city: Parma
country: Italy
facility: Research Site
city: Pavia
country: Italy
facility: Research Site
city: Perugia
country: Italy
facility: Research Site
city: Pordenone
country: Italy
facility: Research Site
city: Reggio Emilia
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Arnhem
country: Netherlands
facility: Research Site
city: Breda
country: Netherlands
facility: Research Site
city: Eindhoven
country: Netherlands
facility: Research Site
city: Geldrop
country: Netherlands
facility: Research Site
city: Geleen
country: Netherlands
facility: Research Site
city: Hoorn
country: Netherlands
facility: Research Site
city: Leeuwarden
country: Netherlands
facility: Research Site
city: Leiden
country: Netherlands
facility: Research Site
city: Nieuwegein
country: Netherlands
facility: Research Site
city: Nijmegen
country: Netherlands
facility: Research Site
city: Tilburg
country: Netherlands
facility: Research Site
city: Venlo
country: Netherlands
facility: Research Site
city: Christchurch
country: New Zealand
facility: Research Site
city: Dunedin
country: New Zealand
facility: Research Site
city: Hamilton
country: New Zealand
facility: Research Site
city: Bodø
country: Norway
facility: Research Site
city: Namsos
country: Norway
facility: Research Site
city: Ochojec
country: Poland
facility: Research Site
state: Katowice
city: Bialystok
country: Poland
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Glogow Malopolski
country: Poland
facility: Research site
city: Grudziadz
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research site
city: Katowice
country: Poland
facility: Research Site
city: Konskie
country: Poland
facility: Research Site
city: Konstancin-Jeziorna
country: Poland
facility: Research site
city: Krakow
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research site
city: Lublin
country: Poland
facility: Research Site
city: Olsztyn
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Zabrze
country: Poland
facility: Research Site
city: Amadora
country: Portugal
facility: Research Site
city: Braga
country: Portugal
facility: Research Site
city: Guimarães
country: Portugal
facility: Research Site
city: Matosinhos
country: Portugal
facility: Research Site
city: Penafiel
country: Portugal
facility: Research Site
city: Santarém
country: Portugal
facility: Research Site
city: Viana do Castelo
country: Portugal
facility: Research Site
city: Vila Nova de Gaia
country: Portugal
facility: Research Site
city: Guaynabo
country: Puerto Rico
facility: Research Site
city: San Juan
country: Puerto Rico
facility: Research Site
city: Banska Bystrica
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Martin
country: Slovakia
facility: Research site
city: Nitra
country: Slovakia
facility: Research Site
city: Presov
country: Slovakia
facility: Research Site
city: Ruzomberok
country: Slovakia
facility: Research Site
city: Trencin
country: Slovakia
facility: Research Site
city: Trnava
country: Slovakia
facility: Research Site
city: Gijon
country: Spain
facility: Research Site
state: Asturias
city: Palma de Mallorca
country: Spain
facility: Research Site
state: Baleares
city: Badalona
country: Spain
facility: Research Site
state: Barcelona
city: L'Hospitalet de Llobregat
country: Spain
facility: Research Site
state: Barcelona
city: Santander
country: Spain
facility: Research Site
state: Cantabria
city: Santiago de Compostela
country: Spain
facility: Research Site
state: La Coruña
city: Santa Cruz de Tenerife
country: Spain
facility: Research Site
state: Tenerife
city: Alzira
country: Spain
facility: Research Site
state: Valencia
city: Avila
country: Spain
facility: Research Site
city: Cádiz
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: Huelva
country: Spain
facility: Research Site
city: Jaén
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Murcia
country: Spain
facility: Research Site
city: Pontevedra
country: Spain
facility: Research Site
city: Bern
country: Switzerland
facility: Research Site
city: Lausanne
country: Switzerland
facility: Research Site
city: Lugano
country: Switzerland
facility: Research Site
city: Bristol
country: United Kingdom
facility: Research Site
state: Avon
city: Exeter
country: United Kingdom
facility: Research Site
state: Devon
city: Plymouth
country: United Kingdom
facility: Research Site
state: Devon
city: Torquay
country: United Kingdom
facility: Research Site
state: Devon
city: Salford
country: United Kingdom
facility: Research Site
state: Greater Manchester
city: Basingstoke
country: United Kingdom
facility: Research Site
state: Hampshire
city: Southampton
country: United Kingdom
facility: Research Site
state: Hampshire
city: Leicester
country: United Kingdom
facility: Research Site
state: Leicestershire
city: Edinburgh
country: United Kingdom
facility: Research Site
state: Lothian Region
city: Liverpool
country: United Kingdom
facility: Research Site
state: Merseyside
city: Norwich
country: United Kingdom
facility: Research Site
state: Norfolk
city: Nottingham
country: United Kingdom
facility: Research Site
state: Nottinghamshire
city: Glasgow
country: United Kingdom
facility: Research Site
state: Strathclyde
city: Dundee
country: United Kingdom
facility: Research Site
state: Tayside Region
city: Newcastle upon Tyne
country: United Kingdom
facility: Research Site
state: Tyne & Wear
city: Birmingham
country: United Kingdom
facility: Research Site
state: West Midlands
city: Leeds
country: United Kingdom
facility: Research Site
state: West Yorkshire
city: Belfast
country: United Kingdom
facility: Research Site
city: Swansea
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: