BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE)

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.

Study Overview

• Status: Completed
• Conditions: Relapsing-Remitting Multiple Sclerosis
• Intervention / Treatment: Drug: dimethyl fumarate; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 1736
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Box Hill, Australia, 3128
    • Research Site
  • Chatswood, Australia, 2067
    • Research Site
  • Fitzroy, Australia, 3065
    • Research Site
  • Geelong, Australia, 3220
    • Research Site
  • Sydney, Australia, 2000
    • Research Site
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • Research Site
    • New Lambton Heights, New South Wales, Australia, 2305
      • Research Site
  • Victoria
    • Melbourne, Victoria, Australia, 3084
      • Research Site
• Austria
  • Graz, Austria, 8036
    • Research Site
  • Linz, Austria, 4021
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  • Vienna, Austria, 1090
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• Belarus
  • Minsk, Belarus, 220114
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  • Minsk, Belarus, 220116
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  • Gomel
    • Belarus, Gomel, Belarus, 246029
      • Research Site
  • Vitebsk
    • Belarus, Vitebsk, Belarus, 210023
      • Research Site
• Belgium
  • Antwerpen, Belgium, 2020
    • Research Site
  • Brugge, Belgium, 8000
    • Research Site
  • Brussels, Belgium, 1200
    • Research Site
  • Charleroi, Belgium, 6000
    • Research Site
  • Damme, Belgium, 8340
    • Research Site
  • Diepenbeek, Belgium, 3590
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  • Hechtel-Eksel, Belgium, 3940
    • Research Site
  • Leuven, Belgium, 3000
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  • Lodelinsart, Belgium, 6042
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  • Sint-Truiden, Belgium, 3800
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• Bosnia and Herzegovina
  • Tuzla, Bosnia and Herzegovina, 75000
    • Research Site
• Bulgaria
  • Ruse, Bulgaria, 7002
    • Research Site
  • Sofia, Bulgaria, 1431
    • Research Site
  • Sofia, Bulgaria, 1309
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  • Sofia, Bulgaria, 1113
    • Research Site
• Canada
  • Edmonton, Canada, T6G 2G3
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  • London, Canada, N6A 5A5
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  • Montreal, Canada, H3A 2B4
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  • Nova Scotia, Canada, B3H 4K4
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  • Ottawa, Canada, K2G 6E2
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  • Regina, Canada, S4T 7T1
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  • Quebec
    • Lévis, Quebec, Canada, G6V 3Z1
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• Croatia
  • Zagreb, Croatia, 10000
    • Research Site
• Czechia
  • Brno, Czechia, 656 91
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  • Jihlava, Czechia, 586 33
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  • Moravska Ostrava, Czechia, 702 00
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  • Olomouc, Czechia, 775 20
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  • Opava, Czechia, 746 01
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  • Ostrava - Vítkovice, Czechia, 70300
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  • Prague, Czechia, 128 08
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  • Prague, Czechia, 150 06
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  • Teplice, Czechia, 415 01
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• Estonia
  • Parnu, Estonia, 80010
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  • Tallinn, Estonia, 10617
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  • Tallinn, Estonia, 10138
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  • Tartu, Estonia, 51014
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• France
  • Amiens, France, 80054
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  • Caen, France, 14033
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  • Clermont-Ferrand, France, 63003
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  • Dijon, France, 21033
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  • Lille, France, 59037
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  • Lyon, France, 69394
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  • Marseille, France, 13385
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  • Montpellier, France, 34090
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  • Nancy, France, 54035
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  • Nice, France, 06002
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  • Paris, France, 75019
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  • Rennes, France, 35033
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  • Strasbourg, France, 67000
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• Germany
  • Bayreuth, Germany, 95445
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  • Berlin, Germany, 10437
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  • Berlin, Germany, 10961
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  • Berlin, Germany, 12099
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  • Berlin, Germany, 12163
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  • Berlin, Germany, 13347
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  • Berlin, Germany, 10625
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  • Bochum, Germany, 44791
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  • Dresden, Germany, 01307
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  • Dusseldorf, Germany, 40212
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  • Erbach, Germany, 64711
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  • Erlangen, Germany, 91054
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  • Essen, Germany, 45257
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  • Halle, Germany, 06120
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  • Hamburg, Germany, 20246
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  • Hamburg, Germany, 20099
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  • Hamburg, Germany, 22083
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  • Hannover, Germany, 30625
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  • Hannover, Germany, 30171
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  • Koeln, Germany, 50935
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  • Leipzig, Germany, 04103
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  • Magdeburg, Germany, 39120
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  • Marburg, Germany, 35043
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  • Minden, Germany, 32429
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  • Munich (München), Germany, 81675
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  • Münster, Germany, 48149
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  • Osnabrück, Germany, 49076
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  • Regensburg, Germany, 93053
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  • Westerstede, Germany, 26655
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  • Bavaria
    • Berg, Bavaria, Germany, 82335
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  • Ibbenbueren
    • Steinfurt, Ibbenbueren, Germany, 49477
      • Research Site
• Greece
  • Athens, Greece, 11527
    • Research Site
  • Thessaloniki, Greece, 57010
    • Research Site
  • Thessaloniki, Greece, 54636
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• India
  • Ahmedabad, India, 380006
    • Research Site
  • Bangalore, India, 560054
    • Research Site
  • Chandigarh, India, 160012
    • Research Site
  • Hyderabad, India, 500082
    • Research Site
  • Kolkata, India, 700054
    • Research Site
  • Kolkata, India, 700068
    • Research Site
  • Ludhiana, India, 141001
    • Research Site
  • Ludhiana, India, 141008
    • Research Site
  • Mangalore, India, 575002
    • Research Site
  • Mumbai, India, 400054
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  • New Delhi, India, 110017
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  • New Delhi, India, 110060
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  • New Delhi, India, 110029
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  • Pune, India, 411001
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  • Pune, India, 411004
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• Ireland
  • Dublin, Ireland, DUBLIN 4
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• Israel
  • Ashkelon, Israel, 78278
    • Research Site
  • Jerusalem, Israel, 9112001
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  • Safed, Israel, 13100
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• Italy
  • Roma, Italy, 00189
    • Research Site
• Latvia
  • Riga, Latvia, LV-1015
    • Research Site
• Mexico
  • Guadalajara, Mexico, 44610
    • Research Site
  • Mexico, Mexico, 06700
    • Research Site
  • Mexico, Mexico, 06720
    • Research Site
  • Mexico, Mexico, 03310
    • Research Site
  • Morelia, Mexico, 58000
    • Research Site
  • San Luis Potosi, Mexico, 78240
    • Research Site
• Moldova, Republic of
  • Chisinau, Moldova, Republic of, 2028
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  • Chisinau, Moldova, Republic of, 2001
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• Netherlands
  • Breda, Netherlands, 4818 CK
    • Research Site
  • Geleen, Netherlands, 6162 BG
    • Research Site
• New Zealand
  • Auckland, New Zealand, 1023
    • Research Site
  • Christchurch, New Zealand, 8011
    • Research Site
  • Hamilton, New Zealand, 3204
    • Research Site
• North Macedonia
  • Skopje, North Macedonia, 1000
    • Research Site
• Poland
  • Bialystok, Poland, 15-276
    • Research Site
  • Bialystok, Poland, 15-402
    • Research Site
  • Gdansk, Poland, 80-952
    • Research Site
  • Gdansk, Poland, 80-803
    • Research Site
  • Gdansk, Poland, 80-299
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  • Katowice, Poland, 40-752
    • Research Site
  • Katowice, Poland, 40-594
    • Research Site
  • Krakow, Poland, 31-505
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  • Lublin, Poland, 20-954
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  • Lódz, Poland, 90-153
    • Research Site
  • Olsztyn, Poland, 10-561
    • Research Site
  • Plewiska, Poland, 62-064
    • Research Site
  • Poznan, Poland, 60-355
    • Research Site
  • Poznan, Poland, 60-539
    • Research Site
  • Szczecin, Poland, 71-252
    • Research Site
  • Szczecin, Poland, 70-215
    • Research Site
  • Warszawa, Poland, 02-097
    • Research Site
  • Warszawa, Poland, 02-507
    • Research Site
  • Warszawa, Poland, 02-957
    • Research Site
  • Wroclaw, Poland, 50-556
    • Research Site
• Puerto Rico
  • Guaynabo, Puerto Rico, 00968
    • Research Site
• Romania
  • Bucuresti, Romania, 020125
    • Research Site
  • Bucuresti, Romania, 050098
    • Research Site
  • Bucuresti, Romania, 011464
    • Research Site
  • Bucuresti, Romania, 022104
    • Research Site
  • Cluj-Napoca, Romania, 400012
    • Research Site
  • Timisoara, Romania, 300736
    • Research Site
  • Târgu Mures, Romania, 540136
    • Research Site
• Serbia
  • Belgrade, Serbia, 11000
    • Research Site
  • Kragujevac, Serbia, 34000
    • Research Site
  • Nis, Serbia, 18000
    • Research Site
  • Novi Sad, Serbia, 21000
    • Research Site
• Slovakia
  • Bratislava, Slovakia, 81369
    • Research Site
  • Bratislava, Slovakia, 82606
    • Research Site
  • Martin, Slovakia, 03659
    • Research Site
• South Africa
  • Cape Town, South Africa, 7925
    • Research Site
  • Durban, South Africa, 4001
    • Research Site
• Spain
  • Barcelona, Spain, 08035
    • Research Site
  • Córdoba, Spain, 14011
    • Research Site
  • Madrid, Spain, 28040
    • Research Site
  • Malaga, Spain, 29010
    • Research Site
  • Sevilla, Spain, 41009
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• Switzerland
  • Basel, Switzerland, 4031
    • Research Site
  • St. Gallen, Switzerland, 9007
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  • Zurich, Switzerland, 8091
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• Ukraine
  • Ivano-Frankivsk, Ukraine, 76018
    • Research Site
  • Kharkiv, Ukraine, 61103
    • Research Site
  • Kharkiv, Ukraine, 61068
    • Research Site
  • Kyiv, Ukraine, 03110
    • Research Site
  • Kyiv, Ukraine, 04112
    • Research Site
  • Lviv, Ukraine, 79010
    • Research Site
  • Odessa, Ukraine, 65117
    • Research Site
  • Poltava, Ukraine, 36011
    • Research Site
  • Vinnytsia, Ukraine, 21005
    • Research Site
  • Zaporizhzhia, Ukraine, 69600
    • Research Site
• United Kingdom
  • London, United Kingdom, W6 8RF
    • Research Site
  • London, United Kingdom, E1 2EF
    • Research Site
  • London, United Kingdom, E1 4AT
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  • London, United Kingdom, SE5 9NT
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  • Newcastle upon Tyne, United Kingdom, NE1 4HH
    • Research Site
  • Oxford, United Kingdom, OX3 9DU
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  • Sheffield, United Kingdom, S10 2JF
    • Research Site
  • Stoke on Trent, United Kingdom, ST4 6QG
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• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Research Site
    • Huntsville, Alabama, United States, 35801
      • Research Site
  • Arizona
    • Mesa, Arizona, United States, 85206
      • Research Site
    • Phoenix, Arizona, United States, 85013
      • Research Site
  • California
    • Loma Linda, California, United States, 92354
      • Research Site
  • Colorado
    • Boulder, Colorado, United States, 80304
      • Research Site
    • Fort Collins, Colorado, United States, 80528
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  • Connecticut
    • North Haven, Connecticut, United States, 06473
      • Research Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
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  • Florida
    • Maitland, Florida, United States, 32751
      • Research Site
    • Miami, Florida, United States, 33136
      • Research Site
    • Naples, Florida, United States, 34102
      • Research Site
    • Sarasota, Florida, United States, 34239
      • Research Site
    • Tampa, Florida, United States, 33612
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Research Site
    • Atlanta, Georgia, United States, 30327
      • Research Site
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Research Site
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Research Site
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Research Site
    • Wichita, Kansas, United States, 67206
      • Research Site
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Research Site
    • Boston, Massachusetts, United States, 02135
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  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Research Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
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  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Research Site
    • Saint Louis, Missouri, United States, 63104
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  • New York
    • Albany, New York, United States, 12206
      • Research Site
    • Amherst, New York, United States, 14226
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    • Buffalo, New York, United States, 14203
      • Research Site
    • Patchogue, New York, United States, 11772
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  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Research Site
    • Raleigh, North Carolina, United States, 27607
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  • Ohio
    • Bellevue, Ohio, United States, 44811
      • Research Site
    • Cleveland, Ohio, United States, 44195
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    • Columbus, Ohio, United States, 43221
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    • Dayton, Ohio, United States, 45417
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  • Oregon
    • Medford, Oregon, United States, 97504
      • Research Site
    • Portland, Oregon, United States, 97225
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  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
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    • Philadelphia, Pennsylvania, United States, 19140
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    • Pittsburgh, Pennsylvania, United States, 15213
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  • Rhode Island
    • Rumford, Rhode Island, United States, 02916
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  • Tennessee
    • Cordova, Tennessee, United States, 38018
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    • Knoxville, Tennessee, United States, 37922
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  • Texas
    • Houston, Texas, United States, 77030
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  • Virginia
    • Newport News, Virginia, United States, 23601
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  • Washington
    • Issaquah, Washington, United States, 98029
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  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 58 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

-Subjects who participated in and completed as per protocol previous BG00012 clinical studies 109MS301 (NCT00420212) or 109MS302 (NCT00451451).

Key Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BG00012 plus placebo; 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.	Drug: dimethyl fumarate; BG00012 capsules; Other Names: BG00012; DMF; Tecfidera; Drug: Placebo; Capsules taken to maintain the blind in the 240 mg BID treatment group.
EXPERIMENTAL: BG00012; 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.	Drug: dimethyl fumarate; BG00012 capsules; Other Names: BG00012; DMF; Tecfidera

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1 up to Week 561

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	Baseline up to Week 288
Percent Change From Baseline in Brain Atrophy	Brain atrophy was measured using magnetic resonance imaging (MRI) technique.	Baseline up to Week 288
Percent Change From Baseline in Magnetization Transfer Ratio (MTR)	Magnetization Transfer Ratio (MTR) was measured using MRI technique.	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.	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.	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.	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.	Baseline, Week 384

Collaborators and Investigators

• Sponsor: Biogen

Publications and helpful links

General Publications

• Mehta 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.
• Gold 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. Erratum In: Ther Adv Neurol Disord. 2020 Oct 21;13:1756286420968357.
• Gold 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 3, 2009
• Primary Completion (ACTUAL): November 8, 2019
• Study Completion (ACTUAL): November 8, 2019

Study Registration Dates

• First Submitted: February 2, 2009
• First Submitted That Met QC Criteria: February 3, 2009
• First Posted (ESTIMATE): February 4, 2009

Study Record Updates

• Last Update Posted (ACTUAL): December 31, 2020
• Last Update Submitted That Met QC Criteria: December 7, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: multiple sclerosis; oral; relapsing; remitting
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Dimethyl Fumarate
• Other Study ID Numbers: 109MS303; 2008-004753-14 (EUDRACT_NUMBER)