Dimethyl Fumarate (DMF) Observational Study (ESTEEM)

May 23, 2023 updated by: Biogen

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)

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.

Study Overview

Status

Completed

Conditions

Multiple Sclerosis

Intervention / Treatment

Drug: dimethyl fumarate

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.

Study Type

Observational

Enrollment (Actual)

5487

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

Argentina
- - Ciudad Autonoma Buenos Aires, Argentina, 1199
    - Research Site
  - Ciudad Autonoma Buenos Aires, Argentina, C1013AAB
    - Research Site
  - Ciudad Autonoma Buenos Aires, Argentina, C1118AAT
    - Research Site
  - Ciudad Autonoma Buenos Aires, Argentina, C1192AAW
    - Research Site
  - Cordoba, Argentina, 5000
    - Research Site
  - Cordoba, Argentina, X5004CDT
    - Research Site
  - Guaymallén, Argentina, 5519
    - Research Site
  - Mendoza, Argentina, M5502AWY
    - Research Site
  - Salta, Argentina, 4400
    - Research Site
  - San Juan, Argentina, 5400
    - Research Site
  - Santiago del Estero, Argentina, 4200
    - Research Site
- Buenos Aires
  - Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, C1181ACH
    - Research Site
  - Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1061ABD
    - Research Site
  - Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1425DKT
    - Research Site
  - Vicente Lopez, Buenos Aires, Argentina, 1602
    - Research Site
- Santa Fe
  - Rosario, Santa Fe, Argentina, S2000DFD
    - Research Site
  - Rosario, Santa Fe, Argentina, S2000
    - Research Site
- Tucuman
  - San Miguel de Tucuman, Tucuman, Argentina, 4000
    - Research Site
Australia
- New South Wales
  - Camperdown, New South Wales, Australia, 2050
    - Research Site
  - Concord, New South Wales, Australia, 2139
    - Research Site
  - Kogarah, New South Wales, Australia, 2217
    - Research Site
  - Liverpool, New South Wales, Australia, 2170
    - Research Site
  - New Lambton Heights, New South Wales, Australia, 2305
    - Research Site
  - Randwick, New South Wales, Australia, 2031
    - Research Site
  - St. Leonards, New South Wales, Australia, 2065
    - Research Site
  - Sydney, New South Wales, Australia, 2109
    - Research Site
  - Westmead, New South Wales, Australia, 2145
    - Research Site
- Queensland
  - Auchenflower, Queensland, Australia, 4066
    - Research Site
  - Gold Coast, Queensland, Australia, 9726
    - Research Site
- South Australia
  - Bedford Park, South Australia, Australia, 5042
    - Research Site
  - Kent Town, South Australia, Australia, 5067
    - Research Site
- Victoria
  - Box Hill, Victoria, Australia, 3128
    - Research Site
  - Clayton, Victoria, Australia, 3168
    - Research Site
  - Geelong, Victoria, Australia, 3220
    - Research Site
  - Heidelberg, Victoria, Australia, 3084
    - Research Site
  - Melbourne, Victoria, Australia, 3181
    - Research Site
  - Melbourne, Victoria, Australia, 3004
    - Research Site
  - Parkville, Victoria, Australia, 3050
    - Research Site
- Western Australia
  - Nedlands, Western Australia, Australia, 6009
    - Research Site
Austria
- - Amstetten, Austria, 3300
    - Research Site
  - Salzburg, Austria, 5020
    - Research Site
  - Vienna, Austria, 1040
    - Research Site
  - Vienna, Austria, 1180
    - Research Site
Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 2T9
    - Research Site
- British Columbia
  - Burnaby, British Columbia, Canada, V5H 4K7
    - Research Site
  - Victoria, British Columbia, Canada, V8R 1J8
    - Research Site
- New Brunswick
  - Moncton, New Brunswick, Canada, E1C 6Z8
    - Research Site
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 1V7
    - Research Site
  - Sydney, Nova Scotia, Canada, B1P 1P3
    - Research Site
- Ontario
  - Cambridge, Ontario, Canada, N1R7L6
    - Research Site
  - London, Ontario, Canada, N6A 5A5
    - Research Site
  - Milton, Ontario, Canada, L9T 5B5
    - Research Site
  - Scarborough, Ontario, Canada, M1R 3A6
    - Research Site
  - Thunder Bay, Ontario, Canada, P7B 6V4
    - Research Site
- Quebec
  - Gatineau, Quebec, Canada, J8Y 1W2
    - Research Site
  - Montreal, Quebec, Canada, H2L 4M1
    - Research Sites
  - Montréal, Quebec, Canada, H2L 4M1
    - Research Site
  - Montréal, Quebec, Canada, H3A 2B4
    - Research Site
- Saskatchewan
  - Regina, Saskatchewan, Canada, S4S 3R8
    - Research Site
Czechia
- - Brno, Czechia, 656 91
    - Research Site
  - Hradec Kralove, Czechia, 50333
    - Research Site
  - Jihlava, Czechia, 58633
    - Research Site
  - Olomouc, Czechia, 77520
    - Research Site
  - Pardubice, Czechia, 532 03
    - Research Site
  - Praha 10, Czechia, 100 34
    - Research Site
  - Teplice, Czechia, 41529
    - Research Site
Denmark
- - Aarhus C, Denmark, 8200
    - Research Site
  - Esbjerg, Denmark, 6715
    - Research Site
  - Glostrup, Denmark, 2600
    - Research Site
  - Odense C, Denmark, 5000
    - Research Site
  - Sønderborg, Denmark, 6400
    - Research Site
France
- - Gonesse, France, 95503
    - Research Site
  - Rambouillet, France, 78120
    - Research Site
- Allier
  - Montlucon, Allier, France, 03113
    - Research Site
- Haut Rhin
  - Mulhouse Cedex, Haut Rhin, France, 68100
    - Research Site
- Haute Garonne
  - Toulouse cedex 9, Haute Garonne, France, 31059
    - Research Site
- Haute Savoie
  - Pringy cedex, Haute Savoie, France, 74374
    - Research Site
- Hauts De Seine
  - Rueil Malmaison, Hauts De Seine, France, 92500
    - Research Site
- Landes
  - Dax cedex, Landes, France, 40107
    - Research Site
- Lot Et Garonne
  - Agen cedex 09, Lot Et Garonne, France, 47923
    - Research Site
- Pyrenees Orientales
  - Perpignan, Pyrenees Orientales, France, 66046
    - Research Site
- Rhone
  - Bron Cedex, Rhone, France, 69677
    - Research Site
- Vendee
  - La Roche sur Yon, Vendee, France, 85925
    - Research Site
- Vosges
  - Epinal cedex, Vosges, France, 88021
    - Research Site
Germany
- - Berlin, Germany, 10713
    - Research Site
  - Berlin, Germany, 10961
    - Research Site
  - Berlin, Germany, 12099
    - Research Site
  - Berlin, Germany, 12163
    - Research Site
  - Berlin, Germany, 13347
    - Research Site
  - Berlin, Germany, 13465
    - Research Site
  - Hamburg, Germany, 20249
    - Research Site
  - Hamburg, Germany, 21149
    - Research Site
  - Neusäß, Germany, 86356
    - Research Site
- Baden Wuerttemberg
  - Freiburg, Baden Wuerttemberg, Germany, 79098
    - Research Site
  - Heidelberg, Baden Wuerttemberg, Germany, 69120
    - Research Site
  - Heidenheim, Baden Wuerttemberg, Germany, 89518
    - Research Site
  - Ladenburg, Baden Wuerttemberg, Germany, 68526
    - Research Site
  - Mannheim, Baden Wuerttemberg, Germany, 68159
    - Research Site
  - Mannheim, Baden Wuerttemberg, Germany, 68161
    - Research Site
  - Ravensburg, Baden Wuerttemberg, Germany, 88212
    - Research Site
  - Singen, Baden Wuerttemberg, Germany, 78224
    - Research Site
  - Sinsheim, Baden Wuerttemberg, Germany, 74889
    - Research Site
  - Stuttgart, Baden Wuerttemberg, Germany, 70176
    - Research Site
  - Stuttgart, Baden Wuerttemberg, Germany, 70178
    - Research Site
  - Stuttgart, Baden Wuerttemberg, Germany, 70182
    - Research Site
  - Ulm, Baden Wuerttemberg, Germany, 89078
    - Research Site
- Bavaria
  - Alzenau, Bavaria, Germany, 63755
    - Research Site
- Bayern
  - Bayreuth, Bayern, Germany, 95445
    - Research Site
  - Bogen, Bayern, Germany, 94327
    - Research Site
  - Erlangen, Bayern, Germany, 91054
    - Research Site
  - Landshut, Bayern, Germany, 84028
    - Research Site
  - Muenchen, Bayern, Germany, 81825
    - Research Site
  - Neuburg, Bayern, Germany, 86633
    - Research Site
  - Nuernberg, Bayern, Germany, 90451
    - Research Site
  - Nürnberg, Bayern, Germany, 90419
    - Research Site
  - Regensburg, Bayern, Germany, 93095
    - Research Site
  - Unterhaching, Bayern, Germany, 82008
    - Research Site
  - Wolfratshausen, Bayern, Germany, 82515
    - Research Site
  - Wuerzburg, Bayern, Germany, 97080
    - Research Site
- Hessen
  - Butzbach, Hessen, Germany, 35510
    - Research Site
  - Eltville, Hessen, Germany, 65343
    - Research Site
  - Erbach, Hessen, Germany, 64711
    - Research Site
  - Eschwege, Hessen, Germany, 37269
    - Research Site
  - Frankfurt, Hessen, Germany, 60313
    - Research Site
  - Frankfurt, Hessen, Germany, 60488
    - Research Site
  - Frankfurt, Hessen, Germany, 60528
    - Research Site
  - Gelnhausen, Hessen, Germany, 63571
    - Research Site
  - Giessen, Hessen, Germany, 35392
    - Research Site
  - Gladenbach, Hessen, Germany, 35075
    - Research Site
  - Kassel, Hessen, Germany, 34121
    - Research Site
  - Wiesbaden, Hessen, Germany, 65183
    - Research Site
- Niedersachsen
  - Buchholz, Niedersachsen, Germany, 21244
    - Research Site
  - Gottingen, Niedersachsen, Germany, 37073
    - Research Site
  - Oldenburg, Niedersachsen, Germany, 26122
    - Research Site
  - Stade, Niedersachsen, Germany, 21682
    - Research Site
- Nordrhein Westfalen
  - Aachen, Nordrhein Westfalen, Germany, 52062
    - Research Site
  - Aachen, Nordrhein Westfalen, Germany, 52078
    - Research Site
  - Bad Honnef, Nordrhein Westfalen, Germany, 53604
    - Research Site
  - Bergisch-Gladbach, Nordrhein Westfalen, Germany, 51429
    - Research Site
  - Bielefeld, Nordrhein Westfalen, Germany, 33647
    - Research Site
  - Bochum, Nordrhein Westfalen, Germany, 44789
    - Research Site
  - Bonn, Nordrhein Westfalen, Germany, 53111
    - Research Site
  - Duesseldorf, Nordrhein Westfalen, Germany, 40211
    - Research Site
  - Essen, Nordrhein Westfalen, Germany, 45138
    - Research Site
  - Hagen, Nordrhein Westfalen, Germany, 58095
    - Research Site
  - Koeln, Nordrhein Westfalen, Germany, 50935
    - Research Site
  - Köln, Nordrhein Westfalen, Germany, 51063
    - Research Site
  - Remscheid, Nordrhein Westfalen, Germany, 42853
    - Research Site
  - Siegen, Nordrhein Westfalen, Germany, 57076
    - Research Site
  - Willich, Nordrhein Westfalen, Germany, 47877
    - Research Site
  - Wuppertal, Nordrhein Westfalen, Germany, 42284
    - Research Site
- Rheinland Pfalz
  - Frankenthal, Rheinland Pfalz, Germany, 67227
    - Research Site
  - Kandel, Rheinland Pfalz, Germany, 76870
    - Research Site
  - Katzenelnbogen, Rheinland Pfalz, Germany, 56368
    - Research Site
  - Rülzheim, Rheinland Pfalz, Germany, 76761
    - Research Site
  - Trier, Rheinland Pfalz, Germany, 54292
    - Research Site
- Sachsen
  - Chemnitz, Sachsen, Germany, 09117
    - Research Site
  - Gorlitz, Sachsen, Germany, 02828
    - Research Site
  - Leipzig, Sachsen, Germany, 04103
    - Research Site
  - Leipzig, Sachsen, Germany, 04229
    - Research Site
  - Wermsdorf, Sachsen, Germany, 04779
    - Research Site
- Sachsen Anhalt
  - Halle, Sachsen Anhalt, Germany, 06120
    - Research Site
  - Magdeburg, Sachsen Anhalt, Germany, 39120
    - Research Site
- Schleswig Holstein
  - Kiel, Schleswig Holstein, Germany, 24105
    - Research Site
- Thueringen
  - Eisenach, Thueringen, Germany, 99817
    - Research Site
  - Erfurt, Thueringen, Germany, 99096
    - Research Site
  - Jena, Thueringen, Germany, 07747
    - Research Site
Hungary
- - Budapest, Hungary, 1145
    - Research Site
  - Budapest, Hungary, 1106
    - Research Site
  - Budapest, Hungary, 1086
    - Research Site
  - Eger, Hungary, 3300
    - Research Site
  - Gyor, Hungary, 9024
    - Research Site
  - Miskolc, Hungary, 3526
    - Research Site
  - Szeged, Hungary, 6725
    - Research Site
  - Tatabanya, Hungary, 2800
    - Research Site
  - Zalaegerszeg, Hungary, 8900
    - Research Site
Ireland
- - Dublin, Ireland, D04 N2E0
    - Research Site
  - Dublin, Ireland, D09 V2N0
    - Research Site
Italy
- - Bari, Italy, 70124
    - Research Site
  - Bergamo, Italy, 24127
    - Research Site
  - Bologna, Italy, 40139
    - Research Site
  - Cagliari, Italy, 09126
    - Research Site
  - Catanzaro, Italy, 88100
    - Research Site
  - Genova, Italy, 16132
    - Research Site
  - Messina, Italy, 98125
    - Research Site
  - Milano, Italy, 20132
    - Research Site
  - Modena, Italy, 41126
    - Research Site
  - Napoli, Italy, 80131
    - Research Site
  - Palermo, Italy, 90127
    - Research Site
  - Palermo, Italy, 90146
    - Research Site
  - Parma, Italy, 43126
    - Research Site
  - Pavia, Italy, 27100
    - Research Site
  - Perugia, Italy, 06156
    - Research Site
  - Pordenone, Italy, 33170
    - Research Site
  - Reggio Emilia, Italy, 42100
    - Research Site
  - Roma, Italy, 00168
    - Research Site
  - Roma, Italy, 00152
    - Research Site
  - Roma, Italy, 00189
    - Research Site
  - Roma, Italy, 00161
    - Research Site
- Ancona
  - Torrette, Ancona, Italy, 60126
    - Research Site
- Brescia
  - Montichiari, Brescia, Italy, 25018
    - Research Site
- Isernia
  - Pozzilli, Isernia, Italy, 86077
    - Research Site
- Milano
  - Legnano, Milano, Italy, 20025
    - Research Site
- Parma
  - Fidenza, Parma, Italy, 43036
    - Research Site
- Torino
  - Orbassano, Torino, Italy, 10043
    - Research Site
- Varese
  - Gallarate, Varese, Italy, 21013
    - Research Site
Netherlands
- - Amsterdam, Netherlands, 1091 AC
    - Research Site
  - Arnhem, Netherlands, 6815 AD
    - Research Site
  - Breda, Netherlands, 4818 CK
    - Research Site
  - Eindhoven, Netherlands, 5623 EJ
    - Research Site
  - Geldrop, Netherlands, 5664 EH
    - Research Site
  - Geleen, Netherlands, 6162 BG
    - Research Site
  - Hoorn, Netherlands, 1624 NP
    - Research Site
  - Leeuwarden, Netherlands, 8934 AD
    - Research Site
  - Leiden, Netherlands, 2334 CK
    - Research Site
  - Nieuwegein, Netherlands, 3435 CM
    - Research Site
  - Nijmegen, Netherlands, 6532 SZ
    - Research Site
  - Tilburg, Netherlands, 5042 AD
    - Research Site
  - Venlo, Netherlands, 5912 BL
    - Research Site
New Zealand
- - Christchurch, New Zealand, 8011
    - Research Site
  - Dunedin, New Zealand, 9016
    - Research Site
  - Hamilton, New Zealand, 3200
    - Research Site
Norway
- - Bodø, Norway, 8005
    - Research Site
  - Namsos, Norway, 7801
    - Research Site
Poland
- - Bialystok, Poland, 15-276
    - Research Site
  - Bydgoszcz, Poland, 85-681
    - Research Site
  - Gdansk, Poland, 80-803
    - Research Site
  - Glogow Malopolski, Poland, 36-060
    - Research Site
  - Grudziadz, Poland, 86-300
    - Research Site
  - Katowice, Poland, 40-752
    - Research Site
  - Katowice, Poland, 40-571
    - Research Site
  - Konskie, Poland, 26-200
    - Research Site
  - Konstancin-Jeziorna, Poland, 05-510
    - Research Site
  - Krakow, Poland, 31-637
    - Research Site
  - Krakow, Poland, 31-503
    - Research Site
  - Lublin, Poland, 20-954
    - Research Site
  - Olsztyn, Poland, 10-561
    - Research Site
  - Poznan, Poland, 60-355
    - Research Site
  - Warszawa, Poland, 04-749
    - Research Site
  - Warszawa, Poland, 02-957
    - Research Site
  - Warszawa, Poland, 02-091
    - Research Site
  - Zabrze, Poland, 41-800
    - Research Site
- Katowice
  - Ochojec, Katowice, Poland, 40-635
    - Research Site
Portugal
- - Amadora, Portugal, 2720-276
    - Research Site
  - Braga, Portugal, 4710-243
    - Research Site
  - Guimarães, Portugal, 4835-044
    - Research Site
  - Matosinhos, Portugal, 4454-509
    - Research Site
  - Penafiel, Portugal, 4560-007
    - Research Site
  - Santarém, Portugal, 2005-177
    - Research Site
  - Viana do Castelo, Portugal, 4901-858
    - Research Site
  - Vila Nova de Gaia, Portugal, 4434-502
    - Research Site
Puerto Rico
- - Guaynabo, Puerto Rico, 00968
    - Research Site
  - San Juan, Puerto Rico, 00921
    - Research Site
Slovakia
- - Banska Bystrica, Slovakia, 97517
    - Research Site
  - Bratislava, Slovakia, 82101
    - Research Site
  - Bratislava, Slovakia, 83101
    - Research Site
  - Martin, Slovakia, 03659
    - Research Site
  - Nitra, Slovakia, 95001
    - Research Site
  - Presov, Slovakia, 08081
    - Research Site
  - Ruzomberok, Slovakia, 03426
    - Research Site
  - Trencin, Slovakia, 91101
    - Research Site
  - Trnava, Slovakia, 917 75
    - Research Site
Spain
- - Avila, Spain, 05004
    - Research Site
  - Cádiz, Spain, 11009
    - Research Site
  - Granada, Spain, 18014
    - Research Site
  - Huelva, Spain, 21080
    - Research Site
  - Jaén, Spain, 23007
    - Research Site
  - Madrid, Spain, 28006
    - Research Site
  - Murcia, Spain, 30008
    - Research Site
  - Pontevedra, Spain, 36071
    - Research Site
- Asturias
  - Gijon, Asturias, Spain, 33206
    - Research Site
- Baleares
  - Palma de Mallorca, Baleares, Spain, 07010
    - Research Site
- Barcelona
  - Badalona, Barcelona, Spain, 08916
    - Research Site
  - L'Hospitalet de Llobregat, Barcelona, Spain, 08907
    - Research Site
- Cantabria
  - Santander, Cantabria, Spain, 38003
    - Research Site
- La Coruña
  - Santiago de Compostela, La Coruña, Spain, 15706
    - Research Site
- Tenerife
  - Santa Cruz de Tenerife, Tenerife, Spain, 38010
    - Research Site
- Valencia
  - Alzira, Valencia, Spain, 46600
    - Research Site
Switzerland
- - Bern, Switzerland, 3010
    - Research Site
  - Lausanne, Switzerland, CH-1011
    - Research Site
  - Lugano, Switzerland, 6900
    - Research Site
United Kingdom
- - Belfast, United Kingdom, BT16 0RH
    - Research Site
  - Swansea, United Kingdom, SA6 6NL
    - Research Site
- Avon
  - Bristol, Avon, United Kingdom, BS10 5NB
    - Research Site
- Devon
  - Exeter, Devon, United Kingdom, EX2 5DW
    - Research Site
  - Plymouth, Devon, United Kingdom, PL6 8DH
    - Research Site
  - Torquay, Devon, United Kingdom, TQ2 7AA
    - Research Site
- Greater Manchester
  - Salford, Greater Manchester, United Kingdom, M6 8HD
    - Research Site
- Hampshire
  - Basingstoke, Hampshire, United Kingdom, RG24 9NA
    - Research Site
  - Southampton, Hampshire, United Kingdom, SO16 6YD
    - Research Site
- Leicestershire
  - Leicester, Leicestershire, United Kingdom, LE5 4PW
    - Research Site
- Lothian Region
  - Edinburgh, Lothian Region, United Kingdom, EH4 2XU
    - Research Site
- Merseyside
  - Liverpool, Merseyside, United Kingdom, L9 7LJ
    - Research Site
- Norfolk
  - Norwich, Norfolk, United Kingdom, NR4 7UY
    - Research Site
- Nottinghamshire
  - Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
    - Research Site
- Strathclyde
  - Glasgow, Strathclyde, United Kingdom, G51 4TF
    - Research Site
- Tayside Region
  - Dundee, Tayside Region, United Kingdom, DD1 9SY
    - Research Site
- Tyne & Wear
  - Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE4 5PL
    - Research Site
- West Midlands
  - Birmingham, West Midlands, United Kingdom, B15 2GB
    - Research Site
- West Yorkshire
  - Leeds, West Yorkshire, United Kingdom, LS1 3EX
    - Research Site
United States
- Alabama
  - Birmingham, Alabama, United States, 35209
    - Research Site
  - Huntsville, Alabama, United States, 35801
    - Research Site
- Arizona
  - Gilbert, Arizona, United States, 85234
    - Research Site
  - Phoenix, Arizona, United States, 85006
    - Research Site
  - Phoenix, Arizona, United States, 85018
    - Research Site
  - Phoenix, Arizona, United States, 85048
    - Research Site
  - Scottsdale, Arizona, United States, 85251
    - Research Site
  - Tucson, Arizona, United States, 85718
    - Research Site
- California
  - Fullerton, California, United States, 92835
    - Research Sites
  - Hanford, California, United States, 93230
    - Research Site
  - Loma Linda, California, United States, 92354
    - Research Site
  - Los Angeles, California, United States, 90048
    - Research Site
  - Los Angeles, California, United States, 90015
    - Research Site
  - Newport Beach, California, United States, 92663
    - Research Site
  - San Francisco, California, United States, 94158
    - Research Site
  - Santa Ana, California, United States, 92704
    - Research Site
- Colorado
  - Aurora, Colorado, United States, 80045
    - Research Site
  - Colorado Springs, Colorado, United States, 80907
    - Research Site
  - Denver, Colorado, United States, 80210
    - Research Site
  - Fort Collins, Colorado, United States, 80528
    - Research Site
- Connecticut
  - Danbury, Connecticut, United States, 06810
    - Research Site
  - Derby, Connecticut, United States, 06418
    - Research Site
  - Hartford, Connecticut, United States, 06112
    - Research Site
  - Norwich, Connecticut, United States, 06360
    - Research Site
- Delaware
  - Dover, Delaware, United States, 19901
    - Research Site
  - Wilmington, Delaware, United States, 19801
    - Research Site
- District of Columbia
  - Washington, District of Columbia, United States, 20007
    - Research Site
  - Washington, District of Columbia, United States, 20037
    - Research Site
- Florida
  - Boca Raton, Florida, United States, 33486
    - Research Sites
  - Gainesville, Florida, United States, 32610
    - Research Site
  - Jacksonville, Florida, United States, 32216
    - Research Site
  - Lighthouse Point, Florida, United States, 33064
    - Research Sites
  - Maitland, Florida, United States, 32751
    - Research Site
  - Miami, Florida, United States, 33125
    - Research Site
  - Port Charlotte, Florida, United States, 33952
    - Research Site
  - Saint Petersburg, Florida, United States, 33710
    - Research Site
  - Saint Petersburg, Florida, United States, 33713
    - Research Site
  - Sarasota, Florida, United States, 34233
    - Research Site
  - Tampa, Florida, United States, 33606
    - Research Site
- Georgia
  - Atlanta, Georgia, United States, 30309
    - Research Site
  - Atlanta, Georgia, United States, 30327
    - Research Site
  - Atlanta, Georgia, United States, 30309
    - Research Sites
  - Augusta, Georgia, United States, 30912
    - Research Site
  - Columbus, Georgia, United States, 31909
    - Research Site
  - Savannah, Georgia, United States, 31406
    - Research Site
- Illinois
  - Chicago, Illinois, United States, 60637
    - Research Site
  - Chicago, Illinois, United States, 60611
    - Research Site
  - Evanston, Illinois, United States, 60201
    - Research Site
  - Herrin, Illinois, United States, 62948
    - Research Site
  - Peoria, Illinois, United States, 61603
    - Research Site
  - Winfield, Illinois, United States, 60190
    - Research Site
- Indiana
  - Elkhart, Indiana, United States, 46514
    - Research Site
  - Indianapolis, Indiana, United States, 46202
    - Research Site
- Iowa
  - Des Moines, Iowa, United States, 50314
    - Research Site
  - Des Moines, Iowa, United States, 50309
    - Research Site
  - Waterloo, Iowa, United States, 50702
    - Research Site
- Kansas
  - Overland Park, Kansas, United States, 66212
    - Research Site
  - Overland Park, Kansas, United States, 66211
    - Research Site
- Kentucky
  - Henderson, Kentucky, United States, 42420
    - Research Site
  - Louisville, Kentucky, United States, 40207
    - Research Site
- Louisiana
  - Hammond, Louisiana, United States, 70403
    - Research Site
  - New Orleans, Louisiana, United States, 70121
    - Research Site
- Maine
  - Rockport, Maine, United States, 04856
    - Research Site
- Maryland
  - Baltimore, Maryland, United States, 21201
    - Research Site
  - Baltimore, Maryland, United States, 21287
    - Research Site
  - Bethesda, Maryland, United States, 20814
    - Research Site
  - Cumberland, Maryland, United States, 21502
    - Research Site
  - Glen Burnie, Maryland, United States, 21061
    - Research Site
- Massachusetts
  - Boston, Massachusetts, United States, 02111
    - Research Site
  - Boston, Massachusetts, United States, 02135
    - Research Site
  - Foxboro, Massachusetts, United States, 02035
    - Research Site
  - Jamaica Plain, Massachusetts, United States, 02130
    - Research Site
  - Lexington, Massachusetts, United States, 02421
    - Research Site
  - Wellesley, Massachusetts, United States, 02481
    - Research Site
  - Worcester, Massachusetts, United States, 01655
    - Research Site
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - Research Site
  - East Lansing, Michigan, United States, 48824
    - Research Site
  - Farmington Hills, Michigan, United States, 48334
    - Research Site
  - West Bloomfield, Michigan, United States, 48322
    - Research Site
- Minnesota
  - Edina, Minnesota, United States, 55435
    - Research Site
  - Minneapolis, Minnesota, United States, 55407
    - Research Sites
- Mississippi
  - Ocean Springs, Mississippi, United States, 39564
    - Research Site
- Missouri
  - Saint Louis, Missouri, United States, 63110
    - Research Site
  - Springfield, Missouri, United States, 65806
    - Research Site
- Montana
  - Billings, Montana, United States, 59101
    - Research Site
  - Great Falls, Montana, United States, 59405
    - Research Site
- Nebraska
  - Lincoln, Nebraska, United States, 68521
    - Research Site
  - Lincoln, Nebraska, United States, 68506
    - Research Sites
  - Wahoo, Nebraska, United States, 68066
    - Research Site
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - Research Site
- New Hampshire
  - Concord, New Hampshire, United States, 03301
    - Research Site
- New Jersey
  - Audubon, New Jersey, United States, 08106
    - Research Site
  - Flemington, New Jersey, United States, 08822
    - Research Site
  - Hackensack, New Jersey, United States, 07601
    - Research Site
  - Livingston, New Jersey, United States, 07039
    - Research Site
  - New Brunswick, New Jersey, United States, 08903
    - Research Site
  - Newark, New Jersey, United States, 07103
    - Research Site
  - Stratford, New Jersey, United States, 08084
    - Research Site
  - Toms River, New Jersey, United States, 08755
    - Research Site
  - West Long Branch, New Jersey, United States, 07764
    - Research Site
- New York
  - Albany, New York, United States, 12206
    - Research Site
  - Cedarhurst, New York, United States, 11516
    - Research Site
  - East Meadow, New York, United States, 11554
    - Research Site
  - Kingston, New York, United States, 12401
    - Research Site
  - New York, New York, United States, 10016
    - Research Site
  - New York, New York, United States, 10029
    - Research Site
  - Patchogue, New York, United States, 11772
    - Research Site
  - Plainview, New York, United States, 11803
    - Research Site
  - Syracuse, New York, United States, 13210
    - Research Site
  - Syracuse, New York, United States, 13202
    - Research Site
- North Carolina
  - Asheville, North Carolina, United States, 28803
    - Research Site
  - Charlotte, North Carolina, United States, 28204
    - Research Sites
  - Charlotte, North Carolina, United States, 28226
    - Research Site
  - Greensboro, North Carolina, United States, 27405
    - Research Site
  - Hendersonville, North Carolina, United States, 28792
    - Research Site
  - Pinehurst, North Carolina, United States, 28370
    - Research Site
  - Raleigh, North Carolina, United States, 27607
    - Research Site
  - Wilmington, North Carolina, United States, 28401
    - Research Sites
  - Winston-Salem, North Carolina, United States, 27157
    - Research Site
- North Dakota
  - Bismarck, North Dakota, United States, 58501
    - Research Site
- Ohio
  - Canton, Ohio, United States, 44735
    - Research Site
  - Centerville, Ohio, United States, 45459
    - Research Site
  - Cincinnati, Ohio, United States, 45267
    - Research Site
  - Cleveland, Ohio, United States, 44195
    - Research Site
  - Columbus, Ohio, United States, 43210
    - Research Site
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - Research Site
  - Tulsa, Oklahoma, United States, 74136
    - Research Site
- Oregon
  - Portland, Oregon, United States, 97239
    - Research Site
  - Portland, Oregon, United States, 97225
    - Research Site
- Pennsylvania
  - Abington, Pennsylvania, United States, 19001
    - Research Site
  - Allentown, Pennsylvania, United States, 18103
    - Research Site
  - Greensburg, Pennsylvania, United States, 15601
    - Research Site
  - Meadowbrook, Pennsylvania, United States, 19046
    - Research Site
  - Monroeville, Pennsylvania, United States, 15146
    - Research Site
  - Natrona Heights, Pennsylvania, United States, 15065
    - Research Site
  - Philadelphia, Pennsylvania, United States, 19107
    - Research Site
  - Pittsburgh, Pennsylvania, United States, 15212
    - Research Site
- South Carolina
  - Columbia, South Carolina, United States, 29203
    - Research Site
  - Greenville, South Carolina, United States, 29605
    - Research Site
  - Spartanburg, South Carolina, United States, 29307
    - Research Site
- Tennessee
  - Franklin, Tennessee, United States, 37064
    - Research Site
  - Knoxville, Tennessee, United States, 37920
    - Research Site
  - Knoxville, Tennessee, United States, 37922
    - Research Site
  - Nashville, Tennessee, United States, 37232
    - Research Site
  - Nashville, Tennessee, United States, 37205
    - Research Site
- Texas
  - Arlington, Texas, United States, 76012
    - Research Site
  - Colleyville, Texas, United States, 76034
    - Research Site
  - Dallas, Texas, United States, 75246
    - Research Site
  - Dallas, Texas, United States, 75390
    - Research Site
  - Houston, Texas, United States, 77030
    - Research Site
- Virginia
  - Norfolk, Virginia, United States, 23502
    - Research Site
  - Richmond, Virginia, United States, 23298
    - Research Site
  - Virginia Beach, Virginia, United States, 23456
    - Research Site
- Washington
  - Kirkland, Washington, United States, 98034
    - Research Site
  - Seattle, Washington, United States, 98101
    - Research Site
  - Spokane, Washington, United States, 99208
    - Research Site
  - Tacoma, Washington, United States, 98405
    - Research Site
  - Tacoma, Washington, United States, 98409
    - Research Site
- Wisconsin
  - Green Bay, Wisconsin, United States, 54301
    - Research Site
  - Green Bay, Wisconsin, United States, 54311
    - Research Site
  - Green Bay, Wisconsin, United States, 54303
    - Research Site
  - Green Bay, Wisconsin, United States, 54308
    - Research Site
  - La Crosse, Wisconsin, United States, 54601
    - Research Site
  - Madison, Wisconsin, United States, 53715
    - Research Site
  - Milwaukee, Wisconsin, United States, 53215
    - Research Site
  - Milwaukee, Wisconsin, United States, 53211
    - Research Site
  - Neenah, Wisconsin, United States, 54956
    - Research Site
  - Waukesha, Wisconsin, United States, 53188
    - 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

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing routine clinical care for Multiple Sclerosis.

Description

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.

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

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
dimethyl fumarate (DMF) Patients with multiple sclerosis receiving dimethyl fumarate (DMF) under routine clinical care	Drug: dimethyl fumarate Provided under routine clinical care Other Names: BG00012 DMF Tecfidera

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The number of participants that experience Adverse Events (AEs) that lead to discontinuation of dimethyl fumarate (DMF) Time Frame: Up to 5 years	Up to 5 years
The number of participants that experience Serious Adverse Events (SAEs) Time Frame: Up to 5 years	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of dimethyl fumarate (DMF) use Time Frame: Up to 5 years		Up to 5 years
dimethyl fumarate (DMF) dosing frequency Time Frame: Up to 5 years		Up to 5 years
Primary reasons for discontinuation of dimethyl fumarate (DMF) use Time Frame: Up to 5 years		Up to 5 years
Frequency of relapses over time Time Frame: Up to 5 years		Up to 5 years
Disease progression as measured by Expanded Disability Status Scale (EDSS) over time Time Frame: Up to 5 years	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
Multiple Sclerosis Impact Scale-29 Items (MSIS-29) physical multiple sclerosis (MS) impact score Time Frame: Up to 5 years	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
Multiple Sclerosis Impact Scale-29 Items (MSIS-29) psychological multiple sclerosis (MS) impact score Time Frame: Up to 5 years	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
EuroQol-5 Dimensions (5 Level) (EQ-5D-5L) index score Time Frame: Up to 5 years	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
EuroQol Visual Analogue Scale (EQ VAS) (0-100 scale) Time Frame: Up to 5 years	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
Modified Fatigue Impact Scale-5 (MFIS-5) total score Time Frame: Up to 5 years	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
Work Productivity and Activity Impairment questionnaire: Multiple Sclerosis, Version 2.0 (WPAI-MS) impairment percentages Time Frame: Up to 5 years	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
Health Care Resource Consumption Questionnaire Time Frame: Up to 5 years	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

Collaborators and Investigators

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

Sponsor

Biogen

Investigators

Study Director: Medical Director, Biogen

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 (Actual)

November 19, 2013

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

October 31, 2022

Study Registration Dates

First Submitted

January 24, 2014

First Submitted That Met QC Criteria

January 24, 2014

First Posted (Estimate)

January 28, 2014

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

109MS401

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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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Multiple Sclerosis

Clinical Trials on dimethyl fumarate

Search Similar Trials

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Drug Interventions

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Conditions

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