Multiple SclerosisESTEEMNCT02047097

Dimethyl Fumarate (DMF) Observational Study

An observational study of Multiple Sclerosis, run by Biogen at 468 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Multiple Sclerosis
What is being tested?: dimethyl fumarate
How many people: 5,487 participants
Where: 468 sitesin 22 countries
Study dates: 19 Nov 2013to 31 Oct 2022
How long will I take part?: 5 Years
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients undergoing routine clinical care for Multiple Sclerosis.

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

468 sites in 22 countries.

Country

City, postcode or hospital

468 sites in 22 countries

United States168 sites

Research Site
Abington, Pennsylvania, 19001
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Albany, New York, 12206
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Allentown, Pennsylvania, 18103
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Ann Arbor, Michigan, 48109
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Arlington, Texas, 76012
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Asheville, North Carolina, 28803
Research Sites
Atlanta, Georgia, 30309
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Atlanta, Georgia, 30309
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Atlanta, Georgia, 30327
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Audubon, New Jersey, 08106
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Augusta, Georgia, 30912
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Aurora, Colorado, 80045
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Baltimore, Maryland, 21201
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Baltimore, Maryland, 21287
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Bethesda, Maryland, 20814
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Billings, Montana, 59101
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Birmingham, Alabama, 35209
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Bismarck, North Dakota, 58501
Research Sites
Boca Raton, Florida, 33486
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Boston, Massachusetts, 02111
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Boston, Massachusetts, 02135
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Canton, Ohio, 44735
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Cedarhurst, New York, 11516
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Centerville, Ohio, 45459
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Charlotte, North Carolina, 28204
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Charlotte, North Carolina, 28226
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Chicago, Illinois, 60611
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Chicago, Illinois, 60637
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Cincinnati, Ohio, 45267
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Cleveland, Ohio, 44195
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Colleyville, Texas, 76034
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Colorado Springs, Colorado, 80907
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Columbia, South Carolina, 29203
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Columbus, Georgia, 31909
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Columbus, Ohio, 43210
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Concord, New Hampshire, 03301
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Cumberland, Maryland, 21502
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Dallas, Texas, 75246
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Dallas, Texas, 75390
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Danbury, Connecticut, 06810
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Denver, Colorado, 80210
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Derby, Connecticut, 06418
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Des Moines, Iowa, 50309
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Des Moines, Iowa, 50314
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Dover, Delaware, 19901
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East Lansing, Michigan, 48824
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East Meadow, New York, 11554
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Edina, Minnesota, 55435
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Elkhart, Indiana, 46514
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Evanston, Illinois, 60201
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Farmington Hills, Michigan, 48334
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Flemington, New Jersey, 08822
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Fort Collins, Colorado, 80528
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Foxborough, Massachusetts, 02035
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Franklin, Tennessee, 37064
Research Sites
Fullerton, California, 92835
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Gainesville, Florida, 32610
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Gilbert, Arizona, 85234
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Glen Burnie, Maryland, 21061
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Great Falls, Montana, 59405
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Green Bay, Wisconsin, 54301
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Green Bay, Wisconsin, 54303
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Green Bay, Wisconsin, 54308
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Green Bay, Wisconsin, 54311
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Greensboro, North Carolina, 27405
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Greensburg, Pennsylvania, 15601
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Greenville, South Carolina, 29605
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Hackensack, New Jersey, 07601
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Hammond, Louisiana, 70403
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Hanford, California, 93230
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Hartford, Connecticut, 06112
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Henderson, Kentucky, 42420
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Hendersonville, North Carolina, 28792
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Herrin, Illinois, 62948
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Houston, Texas, 77030
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Huntsville, Alabama, 35801
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Indianapolis, Indiana, 46202
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Jacksonville, Florida, 32216
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Jamaica Plain, Massachusetts, 02130
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Kingston, New York, 12401
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Kirkland, Washington, 98034
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Knoxville, Tennessee, 37920
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Knoxville, Tennessee, 37922
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La Crosse, Wisconsin, 54601
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Las Vegas, Nevada, 89106
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Lexington, Massachusetts, 02421
Research Sites
Lighthouse PT, Florida, 33064
Research Sites
Lincoln, Nebraska, 68506
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Lincoln, Nebraska, 68521
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Livingston, New Jersey, 07039
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Loma Linda, California, 92354
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Los Angeles, California, 90015
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Los Angeles, California, 90048
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Louisville, Kentucky, 40207
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Madison, Wisconsin, 53715
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Maitland, Florida, 32751
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Meadowbrook, Pennsylvania, 19046
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Miami, Florida, 33125
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Milwaukee, Wisconsin, 53211
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Milwaukee, Wisconsin, 53215
Research Sites
Minneapolis, Minnesota, 55407
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Monroeville, Pennsylvania, 15146
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Nashville, Tennessee, 37205
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Nashville, Tennessee, 37232
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Natrona Heights, Pennsylvania, 15065
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Neenah, Wisconsin, 54956
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New Brunswick, New Jersey, 08903
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New Orleans, Louisiana, 70121
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New York, New York, 10016
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New York, New York, 10029
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Newark, New Jersey, 07103
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Newport Beach, California, 92663
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Norfolk, Virginia, 23502
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Norwich, Connecticut, 06360
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Ocean Springs, Mississippi, 39564
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Oklahoma City, Oklahoma, 73104
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Overland Park, Kansas, 66211
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Overland Park, Kansas, 66212
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Patchogue, New York, 11772
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Peoria, Illinois, 61603
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Philadelphia, Pennsylvania, 19107
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Phoenix, Arizona, 85006
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Phoenix, Arizona, 85018
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Phoenix, Arizona, 85048
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Pinehurst, North Carolina, 28370
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Pittsburgh, Pennsylvania, 15212
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Plainview, New York, 11803
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Port Charlotte, Florida, 33952
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Portland, Oregon, 97225
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Portland, Oregon, 97239
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Raleigh, North Carolina, 27607
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Richmond, Virginia, 23298
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Rockport, Maine, 04856
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San Francisco, California, 94158
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Santa Ana, California, 92704
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Sarasota, Florida, 34233
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Savannah, Georgia, 31406
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Scottsdale, Arizona, 85251
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Seattle, Washington, 98101
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Spartanburg, South Carolina, 29307
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Spokane, Washington, 99208
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Springfield, Missouri, 65806
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St Louis, Missouri, 63110
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St. Petersburg, Florida, 33710
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St. Petersburg, Florida, 33713
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Stratford, New Jersey, 08084
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Syracuse, New York, 13202
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Syracuse, New York, 13210
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Tacoma, Washington, 98405
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Tacoma, Washington, 98409
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Tampa, Florida, 33606
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Toms River, New Jersey, 08755
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Tucson, Arizona, 85718
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Tulsa, Oklahoma, 74136
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Virginia Beach, Virginia, 23456
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Wahoo, Nebraska, 68066
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Washington D.C., District of Columbia, 20007
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Washington D.C., District of Columbia, 20037
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Waterloo, Iowa, 50702
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Waukesha, Wisconsin, 53188
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Wellesley, Massachusetts, 02481
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West Bloomfield, Michigan, 48322
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West Long Branch, New Jersey, 07764
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Wilmington, Delaware, 19801
Research Sites
Wilmington, North Carolina, 28401
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Winfield, Illinois, 60190
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Winston-Salem, North Carolina, 27157
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Worcester, Massachusetts, 01655

Other trials in United States

Germany83 sites

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Aachen, North Rhine-Westphalia, 52062
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Aachen, North Rhine-Westphalia, 52078
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Alzenau in Unterfranken, Bavaria, 63755
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Bad Honnef, North Rhine-Westphalia, 53604
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Bayreuth, Bavaria, 95445
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Bergisch Gladbach, North Rhine-Westphalia, 51429
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Berlin, 10713
Research Site
Berlin, 10961
Research Site
Berlin, 12099
Research Site
Berlin, 12163
Research Site
Berlin, 13347
Research Site
Berlin, 13465
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Bielefeld, North Rhine-Westphalia, 33647
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Bochum, North Rhine-Westphalia, 44789
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Bogen, Bavaria, 94327
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Bonn, North Rhine-Westphalia, 53111
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Buchholz, Lower Saxony, 21244
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Butzbach, Hesse, 35510
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Chemnitz, Saxony, 09117
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Cologne, North Rhine-Westphalia, 50935
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Cologne, North Rhine-Westphalia, 51063
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Düsseldorf, North Rhine-Westphalia, 40211
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Eisenach, Thuringia, 99817
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Eltville, Hesse, 65343
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Erbach im Odenwald, Hesse, 64711
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Erfurt, Thuringia, 99096
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Erlangen, Bavaria, 91054
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Eschwege, Hesse, 37269
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Essen, North Rhine-Westphalia, 45138
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Frankenthal, Rhineland-Palatinate, 67227
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Frankfurt am Main, Hesse, 60313
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Frankfurt am Main, Hesse, 60488
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Frankfurt am Main, Hesse, 60528
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Freiburg im Breisgau, Baden-Wurttemberg, 79098
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Gelnhausen, Hesse, 63571
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Giessen, Hesse, 35392
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Gladenbach, Hesse, 35075
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Görlitz, Saxony, 02828
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Göttingen, Lower Saxony, 37073
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Hagen, North Rhine-Westphalia, 58095
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Halle, Saxony-Anhalt, 06120
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Hamburg, 20249
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Hamburg, 21149
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Heidelberg, Baden-Wurttemberg, 69120
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Heidenheim, Baden-Wurttemberg, 89518
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Jena, Thuringia, 07747
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Kandel, Rhineland-Palatinate, 76870
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Kassel, Hesse, 34121
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Katzenelnbogen, Rhineland-Palatinate, 56368
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Kiel, Schleswig-Holstein, 24105
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Ladenburg, Baden-Wurttemberg, 68526
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Landshut, Bavaria, 84028
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Leipzig, Saxony, 04103
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Leipzig, Saxony, 04229
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Magdeburg, Saxony-Anhalt, 39120
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Mannheim, Baden-Wurttemberg, 68159
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Mannheim, Baden-Wurttemberg, 68161
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Munich, Bavaria, 81825
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Neuburg am Inn, Bavaria, 86633
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Neusäß, 86356
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Nuremberg, Bavaria, 90419
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Nuremberg, Bavaria, 90451
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Oldenburg, Lower Saxony, 26122
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Ravensburg, Baden-Wurttemberg, 88212
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Regensburg, Bavaria, 93095
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Remscheid, North Rhine-Westphalia, 42853
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Rülzheim, Rhineland-Palatinate, 76761
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Siegen, North Rhine-Westphalia, 57076
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Singen, Baden-Wurttemberg, 78224
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Sinsheim, Baden-Wurttemberg, 74889
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Stade, Lower Saxony, 21682
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Stuttgart, Baden-Wurttemberg, 70176
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Stuttgart, Baden-Wurttemberg, 70178
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Stuttgart, Baden-Wurttemberg, 70182
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Trier, Rhineland-Palatinate, 54292
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Ulm, Baden-Wurttemberg, 89078
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Unterhaching, Bavaria, 82008
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Wermsdorf, Saxony, 04779
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Wiesbaden, Hesse, 65183
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Willich, North Rhine-Westphalia, 47877
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Wolfratshausen, Bavaria, 82515
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Wuppertal, North Rhine-Westphalia, 42284
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Würzburg, Bavaria, 97080

Other trials in Germany

Italy28 sites

Research Site
Bari, 70124
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Bergamo, 24127
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Bologna, 40139
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Cagliari, 09126
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Catanzaro, 88100
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Fidenza, Parma, 43036
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Gallarate, Varese, 21013
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Genova, 16132
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Legnano, Milano, 20025
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Messina, 98125
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Milan, 20132
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Modena, 41126
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Montichiari, Brescia, 25018
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Naples, 80131
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Orbassano, Torino, 10043
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Palermo, 90127
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Palermo, 90146
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Parma, 43126
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Pavia, 27100
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Perugia, 06156
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Pordenone, 33170
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Pozzilli, Isernia, 86077
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Reggio Emilia, 42100
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Roma, 00152
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Roma, 00161
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Roma, 00168
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Roma, 00189
Research Site
Torrette, Ancona, 60126

Other trials in Italy

Australia21 sites

Research Site
Auchenflower, Queensland, 4066
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Bedford Park, South Australia, 5042
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Box Hill, Victoria, 3128
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Camperdown, New South Wales, 2050
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Clayton, Victoria, 3168
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Concord, New South Wales, 2139
Research Site
Geelong, Victoria, 3220
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Gold Coast, Queensland, 9726
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Heidelberg, Victoria, 3084
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Kent Town, South Australia, 5067
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Kogarah, New South Wales, 2217
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Liverpool, New South Wales, 2170
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Melbourne, Victoria, 3004
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Melbourne, Victoria, 3181
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Nedlands, Western Australia, 6009
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New Lambton Heights, New South Wales, 2305
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Parkville, Victoria, 3050
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Randwick, New South Wales, 2031
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St Leonards, New South Wales, 2065
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Sydney, New South Wales, 2109
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Westmead, New South Wales, 2145

Other trials in Australia

Poland19 sites

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Bialystok, 15-276
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Bydgoszcz, 85-681
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Gdansk, 80-803
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Głogów Małopolski, 36-060
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Gmina Końskie, 26-200
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Grudziądz, 86-300
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Katowice, 40-571
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Katowice, 40-752
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Konstancin-Jeziorna, 05-510
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Krakow, 31-503
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Krakow, 31-637
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Lublin, 20-954
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Ochojec, Katowice, 40-635
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Olsztyn, 10-561
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Poznan, 60-355
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Warsaw, 02-091
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Warsaw, 02-957
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Warsaw, 04-749
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Zabrze, 41-800

Other trials in Poland

United Kingdom19 sites

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Basingstoke, Hampshire, RG24 9NA
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Belfast, BT16 0RH
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Birmingham, West Midlands, B15 2GB
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Bristol, Avon, BS10 5NB
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Dundee, Tayside Region, DD1 9SY
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Edinburgh, Lothian Region, EH4 2XU
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Exeter, Devon, EX2 5DW
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Glasgow, Strathclyde, G51 4TF
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Leeds, West Yorkshire, LS1 3EX
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Leicester, Leicestershire, LE5 4PW
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Liverpool, Merseyside, L9 7LJ
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Newcastle upon Tyne, Tyne & Wear, NE4 5PL
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Norwich, Norfolk, NR4 7UY
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Nottingham, Nottinghamshire, NG7 2UH
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Plymouth, Devon, PL6 8DH
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Salford, Greater Manchester, M6 8HD
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Southampton, Hampshire, SO16 6YD
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Swansea, SA6 6NL
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Torquay, Devon, TQ2 7AA

Other trials in United Kingdom

Argentina18 sites

Research Site
Ciudad Autonoma Buenos Aires, Buenos Aires, C1181ACH
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Ciudad Autonoma Buenos Aires, 1199
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Ciudad Autonoma Buenos Aires, C1013AAB
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Ciudad Autonoma Buenos Aires, C1118AAT
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Ciudad Autonoma Buenos Aires, C1192AAW
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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1061ABD
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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425DKT
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Córdoba, 5000
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Córdoba, X5004CDT
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Mendoza, M5502AWY
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Rosario, Santa Fe Province, S2000DFD
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Rosario, Santa Fe Province, S2000
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Salta, 4400
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San Juan, 5400
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San Miguel de Tucumán, Tucumán Province, 4000
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Santiago del Estero, 4200
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Vicente López, Buenos Aires, 1602
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Villa Nueva, 5519

Other trials in Argentina

Canada16 sites

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Burnaby, British Columbia, V5H 4K7
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Calgary, Alberta, T2N 2T9
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Cambridge, Ontario, N1R7L6
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Gatineau, Quebec, J8Y 1W2
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Halifax, Nova Scotia, B3H 1V7
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London, Ontario, N6A 5A5
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Milton, Ontario, L9T 5B5
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Moncton, New Brunswick, E1C 6Z8
Research Sites
Montreal, Quebec, H2L 4M1
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Montreal, Quebec, H2L 4M1
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Montreal, Quebec, H3A 2B4
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Regina, Saskatchewan, S4S 3R8
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Scarborough Village, Ontario, M1R 3A6
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Sydney, Nova Scotia, B1P 1P3
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Thunder Bay, Ontario, P7B 6V4
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Victoria, British Columbia, V8R 1J8

Other trials in Canada

Spain16 sites

Research Site
Alzira, Valencia, 46600
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Ávila, 05004
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Badalona, Barcelona, 08916
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Cadiz, 11009
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Gijón, Principality of Asturias, 33206
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Granada, 18014
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Huelva, 21080
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Jaén, 23007
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L'Hospitalet de Llobregat, Barcelona, 08907
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Madrid, 28006
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Murcia, 30008
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Palma de Mallorca, Balearic Islands, 07010
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Pontevedra, 36071
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Santa Cruz de Tenerife, Tenerife, 38010
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Santander, Cantabria, 38003
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Santiago de Compostela, La Coruña, 15706

Other trials in Spain

France13 sites

Research Site
Agen, Lot Et Garonne, 47923
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Bron, Rhone, 69677
Research Site
Dax, Landes, 40107
Research Site
Épinal, Vosges, 88021
Research Site
Gonesse, 95503
Research Site
La Roche-sur-Yon, Vendee, 85925
Research Site
Montluçon, Allier, 03113
Research Site
Mulhouse, Haut Rhin, 68100
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Perpignan, Pyrenees Orientales, 66046
Research Site
Pringy, Haute Savoie, 74374
Research Site
Rambouillet, 78120
Research Site
Rueil-Malmaison, Hauts De Seine, 92500
Research Site
Toulouse, Haute Garonne, 31059

Other trials in France

Netherlands13 sites

Research Site
Amsterdam, 1091 AC
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Arnhem, 6815 AD
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Breda, 4818 CK
Research Site
Eindhoven, 5623 EJ
Research Site
Geldrop, 5664 EH
Research Site
Geleen, 6162 BG
Research Site
Hoorn, 1624 NP
Research Site
Leeuwarden, 8934 AD
Research Site
Leiden, 2334 CK
Research Site
Nieuwegein, 3435 CM
Research Site
Nijmegen, 6532 SZ
Research Site
Tilburg, 5042 AD
Research Site
Venlo, 5912 BL

Other trials in Netherlands

Hungary9 sites

Research Site
Budapest, 1086
Research Site
Budapest, 1106
Research Site
Budapest, 1145
Research Site
Eger, 3300
Research Site
Győr, 9024
Research Site
Miskolc, 3526
Research Site
Szeged, 6725
Research Site
Tatabánya, 2800
Research Site
Zalaegerszeg, 8900

Other trials in Hungary

Slovakia9 sites

Research Site
Banská Bystrica, 97517
Research Site
Bratislava, 82101
Research Site
Bratislava, 83101
Research site
Martin, 03659
Research Site
Nitra, 95001
Research Site
Prešov, 08081
Research Site
Ružomberok, 03426
Research Site
Trenčín, 91101
Research Site
Trnava, 917 75

Other trials in Slovakia

Portugal8 sites

Research Site
Amadora, 2720-276
Research Site
Braga, 4710-243
Research Site
Guimarães, 4835-044
Research Site
Matosinhos Municipality, 4454-509
Research Site
Penafiel, 4560-007
Research Site
Santarém, 2005-177
Research Site
Viana do Castelo, 4901-858
Research Site
Vila Nova de Gaia, 4434-502

Other trials in Portugal

Czechia7 sites

Research Site
Brno, 656 91
Research Site
Hradec Králové, 50333
Research Site
Jihlava, 58633
Research Site
Olomouc, 77520
Research Site
Pardubice, 532 03
Research Site
Prague, 100 34
Research Site
Teplice, 41529

Other trials in Czechia

Denmark5 sites

Research Site
Aarhus C, 8200
Research Site
Esbjerg, 6715
Research Site
Glostrup Municipality, 2600
Research Site
Odense C, 5000
Research Site
Sønderborg, 6400

Other trials in Denmark

Austria4 sites

Research Site
Amstetten, 3300
Research Site
Salzburg, 5020
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Vienna, 1040
Research Site
Vienna, 1180

Other trials in Austria

New Zealand3 sites

Research Site
Christchurch, 8011
Research Site
Dunedin, 9016
Research Site
Hamilton, 3200

Other trials in New Zealand

Switzerland3 sites

Research Site
Bern, 3010
Research Site
Lausanne, CH-1011
Research Site
Lugano, 6900

Other trials in Switzerland

Ireland2 sites

Research Site
Dublin, D04 N2E0
Research Site
Dublin, D09 V2N0

Other trials in Ireland

Norway2 sites

Research Site
Bodø, 8005
Research Site
Namsos, 7801

Other trials in Norway

Puerto Rico2 sites

Research Site
Guaynabo, 00968
Research Site
San Juan, 00921

Other trials in Puerto Rico

About this 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)

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.

Read the 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.

Conditions: Multiple Sclerosis
Being tested: dimethyl fumarate
Medical subject headings: Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

dimethyl fumarateDrug
Also called Tecfidera, DMF, BG00012
Provided under routine clinical care

Study groups in NCT02047097
Study group	Role	What they receive
dimethyl fumarate (DMF)		Patients with multiple sclerosis receiving dimethyl fumarate (DMF) under routine clinical care Receives: Drug: dimethyl fumarate

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (12)

Duration of dimethyl fumarate (DMF) use
Measured: Up to 5 years
dimethyl fumarate (DMF) dosing frequency
Measured: Up to 5 years
Primary reasons for discontinuation of dimethyl fumarate (DMF) use
Measured: Up to 5 years
Frequency of relapses over time
Measured: Up to 5 years
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.
Measured: Up to 5 years
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.
Measured: Up to 5 years
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.
Measured: Up to 5 years
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.
Measured: Up to 5 years
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)
Measured: Up to 5 years
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.
Measured: Up to 5 years
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.
Measured: Up to 5 years
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).
Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Nov 201331 Oct 2022

First posted28 Jan 2014 (estimated)
Study start19 Nov 2013
Primary completion31 Oct 2022
Study completion31 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Multiple SclerosisStudies of the same condition, open and under way.
More trials run by BiogenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 5,487 participants (actual)
Target duration: 5 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT02047097
Sponsor's protocol ID: 109MS401
Acronym: ESTEEM
Status last verified: May 2023
First submitted: 24 Jan 2014
Last updated: 24 May 2023
Results posted: No
Data monitoring committee: No

Publications

Pandey KS, Giles K, Balashov K, Macdonell R, Windsheimer J, Martinez M, Bozin I, Raynaud S, Scaramozza M, Mokliatchouk O, Sun Z, Belviso N, Sato Y, Lin X, Okai A. Long-Term Safety and Effectiveness of Dimethyl Fumarate in Patients with Multiple Sclerosis Treated in Routine Medical Practice: Final Analysis of the ESTEEM Study. Neurol Ther. 2025 Feb;14(1):243-260. doi: 10.1007/s40120-024-00680-z. Epub 2024 Dec 14.
PubMed 39673658
Mao-Draayer Y, Bar-Or A, Balashov K, Foley J, Smoot K, Longbrake EE, Robertson D, Mendoza JP, Lewin JB, Everage N, Bozin I, Lyons J, Mokliatchouk O, Bame E, Giuliani F. Real-World Safety and Effectiveness of Dimethyl Fumarate in Patients with MS: Results from the ESTEEM Phase 4 and PROCLAIM Phase 3 Studies with a Focus on Older Patients. Adv Ther. 2025 Jan;42(1):395-412. doi: 10.1007/s12325-024-03047-w. Epub 2024 Nov 21.
PubMed 39570545
Williams MJ, Amezcua L, Chinea A, Cohan S, Okai A, Okuda DT, Vargas W, Belviso N, Bozin I, Jiang X, Lewin JB, Lyons J, Shen C, England SM, Grimes N. Real-World Safety and Effectiveness After 5 Years of Dimethyl Fumarate Treatment in Black and Hispanic Patients with Multiple Sclerosis in ESTEEM. Neurol Ther. 2023 Oct;12(5):1669-1682. doi: 10.1007/s40120-023-00517-1. Epub 2023 Jun 24.
PubMed 37354276

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Multiple Sclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT02047097
Acronym / sponsor ID: ESTEEM / 109MS401
Conditions: Multiple Sclerosis
Study type: Observational
Recruitment status: Completed
Enrolment: 5,487 participants (actual)
Lead sponsor: BiogenIndustry (pharma, biotech, devices)
Study start: 19 Nov 2013 (actual)
Primary completion: 31 Oct 2022 (actual)
Study completion: 31 Oct 2022 (actual)
First posted: 28 Jan 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 5 Years
Number of arms: 1

Arm	Type	Receives
dimethyl fumarate (DMF)	–	Drug: dimethyl fumaratePatients with multiple sclerosis receiving dimethyl fumarate (DMF) under routine clinical care

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients undergoing routine clinical care for Multiple Sclerosis.

Key inclusion criteria (1 listed)

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 (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
dimethyl fumarateAlso: Tecfidera, DMF, BG00012Provided under routine clinical care	Drug	dimethyl fumarate (DMF)

Primary outcome

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

12 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
Derived from this study: PubMed 39673658Pandey KS, Giles K, Balashov K, Macdonell R, Windsheimer J, Martinez M, Bozin I, Raynaud S, Scaramozza M, Mokliatchouk O, Sun Z, Belviso N, Sato Y, Lin X, Okai A. Long-Term Safety and Effectiveness of Dimethyl Fumarate in Patients with Multiple Sclerosis Treated in Routine Medical Practice: Final Analysis of the ESTEEM Study. Neurol Ther. 2025 Feb;14(1):243-260. doi: 10.1007/s40120-024-00680-z. Epub 2024 Dec 14.
Derived from this study: PubMed 39570545Mao-Draayer Y, Bar-Or A, Balashov K, Foley J, Smoot K, Longbrake EE, Robertson D, Mendoza JP, Lewin JB, Everage N, Bozin I, Lyons J, Mokliatchouk O, Bame E, Giuliani F. Real-World Safety and Effectiveness of Dimethyl Fumarate in Patients with MS: Results from the ESTEEM Phase 4 and PROCLAIM Phase 3 Studies with a Focus on Older Patients. Adv Ther. 2025 Jan;42(1):395-412. doi: 10.1007/s12325-024-03047-w. Epub 2024 Nov 21.
Derived from this study: PubMed 37354276Williams MJ, Amezcua L, Chinea A, Cohan S, Okai A, Okuda DT, Vargas W, Belviso N, Bozin I, Jiang X, Lewin JB, Lyons J, Shen C, England SM, Grimes N. Real-World Safety and Effectiveness After 5 Years of Dimethyl Fumarate Treatment in Black and Hispanic Patients with Multiple Sclerosis in ESTEEM. Neurol Ther. 2023 Oct;12(5):1669-1682. doi: 10.1007/s40120-023-00517-1. Epub 2023 Jun 24.

Related trials for Multiple Sclerosis

RecruitingPhase 3
Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Biogen

468 sites in 22 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis, run by Biogen at 468 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 468 sites in United States, Germany, Italy, Australia, Poland and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of participants that experience Adverse Events (AEs) that lead to discontinuation of dimethyl fumarate (DMF) (time frame: Up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02047097, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.