Relapsing-Remitting Multiple SclerosisPhase 3ENDORSENCT00835770
BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)
A Phase 3 study testing dimethyl fumarate in people with Relapsing-Remitting Multiple Sclerosis, run by Biogen at 246 sites in 34 countries.
Trial summary
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple… Read more about this study
- Who is it for?
- Ages 19 to 58 years
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis
- What is being tested?
- dimethyl fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,736 participants
- Where
- 246 sitesin 34 countries
- Study dates
- 3 Feb 2009to 8 Nov 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 to 58 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- -Subjects who participated in and completed as per protocol previous BG00012 clinical studies 109MS301 (NCT00420212) or 109MS302 (NCT00451451).
Who cannot join
- Any significant change in medical history from 109MS301 or 109MS302 that would have excluded subject's participation from their previous study.
- Subjects from 109MS301 or 109MS302 who discontinued oral study treatment due to an AE or due to reasons other than protocol-defined relapse/disability progression.
- Subjects from 109MS301 or 109MS302 who discontinued study treatment due to disability progression or relapses and did not follow the modified visit schedule up to Week 96.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
246 sites in 34 countries.
246 sites in 34 countries
United States50 sites
Research Site
Albany, New York, 12206
Research Site
Amherst, New York, 14226
Research Site
Atlanta, Georgia, 30309
Research Site
Atlanta, Georgia, 30327
Research Site
Baltimore, Maryland, 21201
Research Site
Bellevue, Ohio, 44811
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Birmingham, Alabama, 35294
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Boston, Massachusetts, 02135
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Boston, Massachusetts, 02215
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Boulder, Colorado, 80304
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Buffalo, New York, 14203
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Charlotte, North Carolina, 28204
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Chesterfield, Missouri, 63017
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Cleveland, Ohio, 44195
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Columbus, Ohio, 43221
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Cordova, Tennessee, 38018
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Dayton, Ohio, 45417
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Evanston, Illinois, 60201
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Farmington Hills, Michigan, 48334
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Fort Collins, Colorado, 80528
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Fort Wayne, Indiana, 46845
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Houston, Texas, 77030
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Huntsville, Alabama, 35801
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Issaquah, Washington, 98029
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Kansas City, Kansas, 66160
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Knoxville, Tennessee, 37922
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Loma Linda, California, 92354
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Madison, Wisconsin, 53792
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Maitland, Florida, 32751
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Medford, Oregon, 97504
research Site
Mesa, Arizona, 85206
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Miami, Florida, 33136
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Minneapolis, Minnesota, 55414
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Naples, Florida, 34102
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Newport News, Virginia, 23601
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North Haven, Connecticut, 06473
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Patchogue, New York, 11772
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Philadelphia, Pennsylvania, 19104
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Philadelphia, Pennsylvania, 19140
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Phoenix, Arizona, 85013
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Pittsburgh, Pennsylvania, 15213
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Portland, Oregon, 97225
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Raleigh, North Carolina, 27607
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Rumford, Rhode Island, 02916
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Sarasota, Florida, 34239
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Shreveport, Louisiana, 71103
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St Louis, Missouri, 63104
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Tampa, Florida, 33612
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Washington D.C., District of Columbia, 20007
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Wichita, Kansas, 67206
Germany31 sites
Research Site
Bayreuth, 95445
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Berg, Bavaria, 82335
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Berlin, 10437
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Berlin, 10625
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Berlin, 10961
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Berlin, 12099
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Berlin, 12163
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Berlin, 13347
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Bochum, 44791
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Cologne, 50935
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Dresden, 01307
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Düsseldorf, 40212
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Erbach im Odenwald, 64711
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Erlangen, 91054
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Essen, 45257
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Halle, 06120
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Hamburg, 20099
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Hamburg, 20246
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Hamburg, 22083
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Hanover, 30171
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Hanover, 30625
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Leipzig, 04103
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Magdeburg, 39120
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Marburg, 35043
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Minden, 32429
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Munich (München), 81675
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Münster, 48149
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Osnabrück, 49076
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Regensburg, 93053
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Steinfurt, Ibbenbueren, 49477
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Westerstede, 26655
Poland20 sites
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Bialystok, 15-276
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Bialystok, 15-402
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Gdansk, 80-299
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Gdansk, 80-803
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Gdansk, 80-952
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Katowice, 40-594
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Katowice, 40-752
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Krakow, 31-505
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Lódz, 90-153
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Lublin, 20-954
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Olsztyn, 10-561
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Plewiska, 62-064
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Poznan, 60-355
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Poznan, 60-539
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Szczecin, 70-215
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Szczecin, 71-252
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Warsaw, 02-097
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Warsaw, 02-507
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Warsaw, 02-957
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Wroclaw, 50-556
India15 sites
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Ahmedabad, 380006
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Bangalore, 560054
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Chandigarh, 160012
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Hyderabad, 500082
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Kolkata, 700054
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Kolkata, 700068
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Ludhiana, 141001
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Ludhiana, 141008
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Mangalore, 575002
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Mumbai, 400054
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New Delhi, 110017
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New Delhi, 110029
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New Delhi, 110060
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Pune, 411001
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Pune, 411004
France13 sites
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Amiens, 80054
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Caen, 14033
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Clermont-Ferrand, 63003
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Dijon, 21033
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Lille, 59037
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Lyon, 69394
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Marseille, 13385
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Montpellier, 34090
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Nancy, 54035
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Nice, 06002
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Paris, 75019
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Rennes, 35033
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Strasbourg, 67000
Belgium10 sites
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Antwerp, 2020
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Bruges, 8000
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Brussels, 1200
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Charleroi, 6000
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Damme, 8340
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Diepenbeek, 3590
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Hechtel-Eksel, 3940
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Leuven, 3000
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Lodelinsart, 6042
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Sint-Truiden, 3800
Ukraine10 sites
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Ivano-Frankivsk, 76018
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Kharkiv, 61068
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Kharkiv, 61103
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Kyiv, 03110
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Kyiv, 04112
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Lviv, 79010
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Odesa, 65117
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Poltava, 36011
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Vinnytsia, 21005
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Zaporizhzhya, 69600
Czechia9 sites
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Brno, 656 91
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Jihlava, 586 33
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Moravská Ostrava, 702 00
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Olomouc, 775 20
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Opava, 746 01
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Ostrava - Vítkovice, 70300
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Prague, 128 08
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Prague, 150 06
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Teplice, 415 01
Australia8 sites
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Box Hill, 3128
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Chatswood, 2067
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Fitzroy, 3065
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Geelong, 3220
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Kogarah, New South Wales, 2217
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Melbourne, Victoria, 3084
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New Lambton Heights, New South Wales, 2305
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Sydney, 2000
United Kingdom8 sites
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London, E1 2EF
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London, E1 4AT
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London, SE5 9NT
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London, W6 8RF
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Newcastle upon Tyne, NE1 4HH
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Oxford, OX3 9DU
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Sheffield, S10 2JF
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Stoke-on-Trent, ST4 6QG
Canada7 sites
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Edmonton, T6G 2G3
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Lévis, Quebec, G6V 3Z1
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London, N6A 5A5
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Montreal, H3A 2B4
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Nova Scotia, B3H 4K4
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Ottawa, K2G 6E2
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Regina, S4T 7T1
Romania7 sites
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Bucharest, 011464
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Bucharest, 020125
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Bucharest, 022104
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Bucharest, 050098
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Cluj-Napoca, 400012
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Târgu Mures, 540136
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Timișoara, 300736
Mexico6 sites
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Guadalajara, 44610
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México, 03310
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México, 06700
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México, 06720
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Morelia, 58000
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San Luis Potosí City, 78240
Spain5 sites
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Barcelona, 08035
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Córdoba, 14011
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Madrid, 28040
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Málaga, 29010
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Seville, 41009
Belarus4 sites
Research Site
Belarus, Homyel’ Voblasc’, 246029
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Belarus’, Vitebsk Oblast, 210023
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Minsk, 220114
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Minsk, 220116
Bulgaria4 sites
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Rousse, 7002
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Sofia, 1113
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Sofia, 1309
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Sofia, 1431
Estonia4 sites
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Pärnu, 80010
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Tallinn, 10138
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Tallinn, 10617
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Tartu, 51014
Serbia4 sites
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Belgrade, 11000
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Kragujevac, 34000
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Niš, 18000
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Novi Sad, 21000
Austria3 sites
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Graz, 8036
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Linz, 4021
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Vienna, 1090
Greece3 sites
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Athens, 11527
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Thessaloniki, 54636
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Thessaloniki, 57010
Israel3 sites
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Ashkelon, 78278
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Jerusalem, 9112001
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Safed, 13100
New Zealand3 sites
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Auckland, 1023
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Christchurch, 8011
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Hamilton, 3204
Slovakia3 sites
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Bratislava, 81369
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Bratislava, 82606
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Martin, 03659
Switzerland3 sites
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Basel, 4031
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Sankt Gallen, 9007
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Zurich, 8091
Netherlands2 sites
Research Site
Breda, 4818 CK
Research Site
Geleen, 6162 BG
South Africa2 sites
Research Site
Cape Town, 7925
Research Site
Durban, 4001
About this study
Official title: A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects With Relapsing-Remitting Multiple Sclerosis
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test.
Read the detailed description
The initial BG00012 dosage for the extension study (240 mg BID or 240 mg TID) was the same as that used in the Phase 3 Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451). Subsequent to the initiation of this study, BG00012 was approved in several countries for the treatment of MS at a dose of 240 mg BID. For this reason, all participants continuing in this study will receive the currently marketed dose of 240 mg BID.
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Being tested
- dimethyl fumarate, Placebo
- Keywords
- relapsing, multiple sclerosis, remitting, oral
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Recurrence, 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 BG00012, Tecfidera, DMF
BG00012 capsules
PlaceboDrug
Capsules taken to maintain the blind in the 240 mg BID treatment group.
| Study group | Role | What they receive |
|---|---|---|
| BG00012 plus placebo | Experimental | In the first phase, participants will receive BG00012 240 mg (two 120 mg capsules) twice a day (BID) and 2 placebo capsules once a day. In the second phase participants will receive open-label BG00012 240 mg BID, for atleast 8 years. Receives: Drug: dimethyl fumarate; Drug: Placebo |
| BG00012 | Experimental | In the first phase participants will receive BG00012 240 mg (two 120 mg capsules) three times a day (TID). In the second phase participants will receive open-label BG00012 240 mg BID for atleast 8 years. Receives: Drug: dimethyl fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (AEs)
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Measured: Day 1 up to Week 561
Secondary outcomes (15)
Percentage of Participants Who Had Relapses
Relapses were defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours.
Measured: Day 1 up to Week 384
Annualized Relapse Rate (ARR)
The annualized relapse rate is calculated as the total number of relapses occurred during the period for all participants, divided by the total number of participant-years followed in the period.
Measured: Day 1 up to Week 384
Change From Baseline in the Expanded Disability Status Scale (EDSS) at Week 384
EDSS scale ranges from 0 (Normal neurological exam, no disability) to 10 (Death) in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. Sustained disability progression was defined as at least a 1.0 point increase on the EDSS from a baseline EDSS ≥1.0 that was sustained for at least 24 weeks, or a 1.5 point increase on the EDSS from a baseline EDSS =0 that was sustained for at least 24 weeks.
Measured: Baseline, Week 384
Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI)
The Gd-enhancing lesions was evaluated using MRI technique.
Measured: Baseline up to Week 288
Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI)
The Gd-enhancing lesions was evaluated using MRI technique.
Measured: Baseline up to Week 288
Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI)
The T2 lesions was evaluated using MRI technique.
Measured: Baseline up to Week 288
Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI)
The T2 lesions was evaluated using MRI technique.
Measured: Baseline up to Week 288
Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI)
The T1 hypointense lesions was evaluated using MRI technique.
Measured: Baseline up to Week 288
Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI)
The T1 hypointense lesions was evaluated using MRI technique.
Measured: Baseline up to Week 288
Percent Change From Baseline in Brain Atrophy
Brain atrophy was measured using magnetic resonance imaging (MRI) technique.
Measured: Baseline up to Week 288
Percent Change From Baseline in Magnetization Transfer Ratio (MTR)
Magnetization Transfer Ratio (MTR) was measured using MRI technique.
Measured: Baseline up to Week 288
Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384
The SF-36 is a brief (36-item) scale reflecting the impact of both dysfunctions and general health perception the questionnaire measures: 1.physical function (PF),2. role physical (RF),3. bodily pain (BP),4. role emotional (RE),5. social function (SF), 6. general health (GH),7. vitality (VT), 8. mental health (MH). Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of the SF-36. The questions related to each dimension are scored on a scale from 0 (worst score) to 100 (best score), with higher scores indicating better function.
Measured: Baseline, Week 384
Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - EQ-5D Index Score at Week 384
The EQ-5D is a generic health-related quality of life instrument consisting of 2 components, EQ-5D index score and EQ-VAS. The EQ-5D provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has (1) "no problems", (2) "some problems", or (3) "severe problems". A positive change from baseline indicates improvement.
Measured: Baseline, Week 384
Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - Visual Analog Scale (VAS) at Week 384
The EQ-5D is a generic health-related quality of life instrument consisting of 2 components, EQ-5D index score and EQ-VAS. In EQ-VAS participants are asked to rate their current health on a 20 centimeter (cm) scale from 0 to 100 where 0 represents "worst imaginable health state" and 100 represents "best imaginable health state". A positive change from baseline indicates improvement.
Measured: Baseline, Week 384
Change From Baseline in Visual Function Test Scores at Week 384
Participants were tested using the contrast level of 100%, 2.5%, and 1.25% charts, and the scores were defined as the number of letters identified correctly for each chart (the maximum score was 60). Higher scores indicate better functioning. A positive change from baseline indicates better functioning.
Measured: Baseline, Week 384
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study start3 Feb 2009
- Primary completion8 Nov 2019
- Study completion8 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Relapsing-Remitting 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,736 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00835770
- Sponsor's protocol ID
- 109MS303
- Other IDs
- 2008-004753-14, 2008
- Acronym
- ENDORSE
- Status last verified
- Dec 2020
- First submitted
- 2 Feb 2009
- Last updated
- 31 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Amezcua L, Mao-Draayer Y, Vargas WS, Farber R, Schaefer S, Branco F, England SM, Belviso N, Lewin JB, Mendoza JP, Shankar SL; ENDORSE Study Investigators. Efficacy of Dimethyl Fumarate in Young Adults with Relapsing-Remitting Multiple Sclerosis: Analysis of the DEFINE, CONFIRM, and ENDORSE Studies. Neurol Ther. 2023 Jun;12(3):883-897. doi: 10.1007/s40120-023-00475-8. Epub 2023 Apr 15.
PubMed 37061656Gold R, Arnold DL, Bar-Or A, Fox RJ, Kappos L, Chen C, Parks B, Miller C. Safety and efficacy of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis: 9 years' follow-up of DEFINE, CONFIRM, and ENDORSE. Ther Adv Neurol Disord. 2020 May 12;13:1756286420915005. doi: 10.1177/1756286420915005. eCollection 2020.
PubMed 32426039Mehta D, Miller C, Arnold DL, Bame E, Bar-Or A, Gold R, Hanna J, Kappos L, Liu S, Matta A, Phillips JT, Robertson D, von Hehn CA, Campbell J, Spach K, Yang L, Fox RJ. Effect of dimethyl fumarate on lymphocytes in RRMS: Implications for clinical practice. Neurology. 2019 Apr 9;92(15):e1724-e1738. doi: 10.1212/WNL.0000000000007262. Epub 2019 Mar 27.
PubMed 30918100Gold R, Giovannoni G, Phillips JT, Fox RJ, Zhang A, Marantz JL. Sustained Effect of Delayed-Release Dimethyl Fumarate in Newly Diagnosed Patients with Relapsing-Remitting Multiple Sclerosis: 6-Year Interim Results From an Extension of the DEFINE and CONFIRM Studies. Neurol Ther. 2016 Jun;5(1):45-57. doi: 10.1007/s40120-016-0042-8. Epub 2016 Mar 1.
PubMed 26932146
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects With Relapsing-Remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00835770
- Acronym / sponsor ID
- ENDORSE / 109MS303
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Keywords
- relapsing, multiple sclerosis, remitting, oral
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,736 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2009 (actual)
- Primary completion
- 8 Nov 2019 (actual)
- Study completion
- 8 Nov 2019 (actual)
- First posted
- 4 Feb 2009 (estimated)
- Results
- Posted 31 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test.
Detailed description
The initial BG00012 dosage for the extension study (240 mg BID or 240 mg TID) was the same as that used in the Phase 3 Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451). Subsequent to the initiation of this study, BG00012 was approved in several countries for the treatment of MS at a dose of 240 mg BID. For this reason, all participants continuing in this study will receive the currently marketed dose of 240 mg BID.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BG00012 plus placebo | Experimental | Drug: dimethyl fumarate, Drug: PlaceboIn the first phase, participants will receive BG00012 240 mg (two 120 mg capsules) twice a day (BID) and 2 placebo capsules once a day. In the second phase participants will receive open-label BG00012 240 mg BID, for atleast 8 years. |
| BG00012 | Experimental | Drug: dimethyl fumarateIn the first phase participants will receive BG00012 240 mg (two 120 mg capsules) three times a day (TID). In the second phase participants will receive open-label BG00012 240 mg BID for atleast 8 years. |
Who may qualify
- Ages
- 19 to 58 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -Subjects who participated in and completed as per protocol previous BG00012 clinical studies 109MS301 (NCT00420212) or 109MS302 (NCT00451451).
Key exclusion criteria (4 listed)
- Any significant change in medical history from 109MS301 or 109MS302 that would have excluded subject's participation from their previous study.
- Subjects from 109MS301 or 109MS302 who discontinued oral study treatment due to an AE or due to reasons other than protocol-defined relapse/disability progression.
- Subjects from 109MS301 or 109MS302 who discontinued study treatment due to disability progression or relapses and did not follow the modified visit schedule up to Week 96.
- 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: BG00012, Tecfidera, DMFBG00012 capsules | Drug | BG00012, BG00012 plus placebo |
| PlaceboCapsules taken to maintain the blind in the 240 mg BID treatment group. | Drug | BG00012 plus placebo |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (AEs)
Time frame: Day 1 up to Week 561
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
15 secondary outcomes
Percentage of Participants Who Had Relapses
Time frame: Day 1 up to Week 384
Annualized Relapse Rate (ARR)
Time frame: Day 1 up to Week 384
Change From Baseline in the Expanded Disability Status Scale (EDSS) at Week 384
Time frame: Baseline, Week 384
Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI)
Time frame: Baseline up to Week 288
Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI)
Time frame: Baseline up to Week 288
Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI)
Time frame: Baseline up to Week 288
Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI)
Time frame: Baseline up to Week 288
Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI)
Time frame: Baseline up to Week 288
Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI)
Time frame: Baseline up to Week 288
Percent Change From Baseline in Brain Atrophy
Time frame: Baseline up to Week 288
Percent Change From Baseline in Magnetization Transfer Ratio (MTR)
Time frame: Baseline up to Week 288
Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384
Time frame: Baseline, Week 384
Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - EQ-5D Index Score at Week 384
Time frame: Baseline, Week 384
Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - Visual Analog Scale (VAS) at Week 384
Time frame: Baseline, Week 384
Change From Baseline in Visual Function Test Scores at Week 384
Time frame: Baseline, Week 384
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37061656Amezcua L, Mao-Draayer Y, Vargas WS, Farber R, Schaefer S, Branco F, England SM, Belviso N, Lewin JB, Mendoza JP, Shankar SL; ENDORSE Study Investigators. Efficacy of Dimethyl Fumarate in Young Adults with Relapsing-Remitting Multiple Sclerosis: Analysis of the DEFINE, CONFIRM, and ENDORSE Studies. Neurol Ther. 2023 Jun;12(3):883-897. doi: 10.1007/s40120-023-00475-8. Epub 2023 Apr 15.
- Derived from this study: PubMed 32426039Gold R, Arnold DL, Bar-Or A, Fox RJ, Kappos L, Chen C, Parks B, Miller C. Safety and efficacy of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis: 9 years' follow-up of DEFINE, CONFIRM, and ENDORSE. Ther Adv Neurol Disord. 2020 May 12;13:1756286420915005. doi: 10.1177/1756286420915005. eCollection 2020.
- Derived from this study: PubMed 30918100Mehta D, Miller C, Arnold DL, Bame E, Bar-Or A, Gold R, Hanna J, Kappos L, Liu S, Matta A, Phillips JT, Robertson D, von Hehn CA, Campbell J, Spach K, Yang L, Fox RJ. Effect of dimethyl fumarate on lymphocytes in RRMS: Implications for clinical practice. Neurology. 2019 Apr 9;92(15):e1724-e1738. doi: 10.1212/WNL.0000000000007262. Epub 2019 Mar 27.
- Derived from this study: PubMed 26932146Gold R, Giovannoni G, Phillips JT, Fox RJ, Zhang A, Marantz JL. Sustained Effect of Delayed-Release Dimethyl Fumarate in Newly Diagnosed Patients with Relapsing-Remitting Multiple Sclerosis: 6-Year Interim Results From an Extension of the DEFINE and CONFIRM Studies. Neurol Ther. 2016 Jun;5(1):45-57. doi: 10.1007/s40120-016-0042-8. Epub 2016 Mar 1.
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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
246 sites in 34 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dimethyl fumarate in people with Relapsing-Remitting Multiple Sclerosis, run by Biogen at 246 sites in 34 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 4 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 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 246 sites in United States, Germany, Poland, India, France and 29 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment-Emergent Adverse Events (AEs) (time frame: Day 1 up to Week 561). 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 NCT00835770, which also lists 4 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 31 Dec 2020; AzTrials last refreshed its copy on 3 Nov 2026.