Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00451451
Registration number
NCT00451451
Ethics application status
Date submitted
21/03/2007
Date registered
23/03/2007
Date last updated
26/01/2015
Titles & IDs
Public title
Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis
Query!
Scientific title
A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis
Query!
Secondary ID [1]
0
0
109MS302
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
CONFIRM
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Relapsing-Remitting Multiple Sclerosis
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Experimental: BG00012 240 mg Twice Daily (BID) - Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
Experimental: BG00012 240 mg 3 Times Daily (TID) - Participants received two 120 mg BG00012 capsules orally three times daily (TID)
Placebo comparator: Placebo - Participants received two placebo capsules orally three times daily (TID)
Active comparator: Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD) - Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Annualized Relapse Rate
Query!
Assessment method [1]
0
0
A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee.
The adjusted annualized relapse rate was calculated from a negative binomial regression model , adjusted for baseline Expanded Disability Status Scale (EDSS ) score(=2.0 versus\>2.0), age (\<40 versus =40 years), region, and the number of relapses in the 1 year prior to enrollment.
Query!
Timepoint [1]
0
0
2 years
Query!
Secondary outcome [1]
0
0
Number of New or Newly Enlarging T2 Hyperintense Lesions
Query!
Assessment method [1]
0
0
The number of new or newly enlarging T2 hyperintense lesions at 2 years that developed in each subject compared to baseline assessed on brain magnetic resonance imaging (MRI) scans. The estimates of mean T2 hyperintense lesion count were calculated from a negative binomial regression model adjusted for region and baseline T2 hyperintense lesion volume.
Query!
Timepoint [1]
0
0
2 years
Query!
Secondary outcome [2]
0
0
Number of New T1 Hypointense Lesions
Query!
Assessment method [2]
0
0
The number of new T1 hypointense lesions at 2 years that developed in each subject compared to baseline assessed on brain magnetic resonance imaging (MRI) scans. The estimates of mean T1 hypointense lesion count were calculated from a negative binomial regression model adjusted for region and baseline T1 hypointense lesion volume.
Query!
Timepoint [2]
0
0
2 years
Query!
Secondary outcome [3]
0
0
Proportion of Subjects Relapsed
Query!
Assessment method [3]
0
0
A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee. The proportion of subjects with a relapse was estimated using the Kaplan-Meier method, which was based on the time-to-first-relapse survival distribution.
Query!
Timepoint [3]
0
0
2 years
Query!
Secondary outcome [4]
0
0
Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS)
Query!
Assessment method [4]
0
0
EDSS is based on a standardized neurological exam and focuses on symptoms that commonly occur in MS. Scores range from 0.0 (normal) to 10.0 (death due to MS). Disability progression was defined as = 1.0 point increase in subjects with a baseline EDSS of =1.0, or =1.5 point increase in subjects with a baseline EDSS=0, and required that the increase from baseline was confirmed = 12weeks later. The proportion of subjects with confirmed (12-week) disability progression was estimated using the Kaplan-Meier method, which was based on the time-to-first-progression survival distribution
Query!
Timepoint [4]
0
0
2 years
Query!
Eligibility
Key inclusion criteria
Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:
Key
* Must have confirmed diagnosis of RRMS according to McDonald criteria #1-4
* Must have a baseline EDSS between 0.0 and 5.0, inclusive.
* Must have relapsing-remitting disease course.
Key
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
55
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease
* Pregnant or nursing women
Note: Other protocol-defined inclusion/exclusion criteria may apply.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/06/2007
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/08/2011
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1417
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Idaho
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Indiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Kansas
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Kentucky
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Louisiana
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Maryland
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Massachusetts
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Michigan
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New Hampshire
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
New Jersey
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New York
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
North Carolina
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Ohio
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Oklahoma
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Oregon
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Pennsylvania
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Tennessee
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Texas
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Utah
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Vermont
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Virginia
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Washington
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Wisconsin
Query!
Country [30]
0
0
Belarus
Query!
State/province [30]
0
0
Gomel
Query!
Country [31]
0
0
Belarus
Query!
State/province [31]
0
0
Minsk
Query!
Country [32]
0
0
Belarus
Query!
State/province [32]
0
0
Vitebsk
Query!
Country [33]
0
0
Belgium
Query!
State/province [33]
0
0
Lommel
Query!
Country [34]
0
0
Belgium
Query!
State/province [34]
0
0
Sijsele-Damme
Query!
Country [35]
0
0
Belgium
Query!
State/province [35]
0
0
Woluwe
Query!
Country [36]
0
0
Bosnia and Herzegovina
Query!
State/province [36]
0
0
B&H Federation
Query!
Country [37]
0
0
Bosnia and Herzegovina
Query!
State/province [37]
0
0
Republic Srpska
Query!
Country [38]
0
0
Bosnia and Herzegovina
Query!
State/province [38]
0
0
Sarajevo B&H Federation
Query!
Country [39]
0
0
Bulgaria
Query!
State/province [39]
0
0
Plovdiv
Query!
Country [40]
0
0
Bulgaria
Query!
State/province [40]
0
0
Rousse
Query!
Country [41]
0
0
Bulgaria
Query!
State/province [41]
0
0
Sofia
Query!
Country [42]
0
0
Bulgaria
Query!
State/province [42]
0
0
Stara Zagora
Query!
Country [43]
0
0
Bulgaria
Query!
State/province [43]
0
0
Varna
Query!
Country [44]
0
0
Canada
Query!
State/province [44]
0
0
Edmonton
Query!
Country [45]
0
0
Canada
Query!
State/province [45]
0
0
London
Query!
Country [46]
0
0
Canada
Query!
State/province [46]
0
0
Montreal
Query!
Country [47]
0
0
Canada
Query!
State/province [47]
0
0
Osijek
Query!
Country [48]
0
0
Costa Rica
Query!
State/province [48]
0
0
San Jose
Query!
Country [49]
0
0
Croatia
Query!
State/province [49]
0
0
Rijeka
Query!
Country [50]
0
0
Croatia
Query!
State/province [50]
0
0
Zagreb
Query!
Country [51]
0
0
Czech Republic
Query!
State/province [51]
0
0
Ostrava-Moravska
Query!
Country [52]
0
0
Czech Republic
Query!
State/province [52]
0
0
Ostrava
Query!
Country [53]
0
0
Czech Republic
Query!
State/province [53]
0
0
Praha
Query!
Country [54]
0
0
Estonia
Query!
State/province [54]
0
0
Kuressaare
Query!
Country [55]
0
0
Estonia
Query!
State/province [55]
0
0
Parnu
Query!
Country [56]
0
0
Estonia
Query!
State/province [56]
0
0
Tallinn
Query!
Country [57]
0
0
Estonia
Query!
State/province [57]
0
0
Tartu
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Caen
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Dijon
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Marseille
Query!
Country [61]
0
0
France
Query!
State/province [61]
0
0
Montpellier
Query!
Country [62]
0
0
France
Query!
State/province [62]
0
0
Nancy
Query!
Country [63]
0
0
France
Query!
State/province [63]
0
0
Nimes
Query!
Country [64]
0
0
France
Query!
State/province [64]
0
0
Strasbourg
Query!
Country [65]
0
0
Germany
Query!
State/province [65]
0
0
Bamberg
Query!
Country [66]
0
0
Germany
Query!
State/province [66]
0
0
Bayreuth
Query!
Country [67]
0
0
Germany
Query!
State/province [67]
0
0
Berg Starnberger
Query!
Country [68]
0
0
Germany
Query!
State/province [68]
0
0
Berlin
Query!
Country [69]
0
0
Germany
Query!
State/province [69]
0
0
Dusseldorf
Query!
Country [70]
0
0
Germany
Query!
State/province [70]
0
0
Erbach
Query!
Country [71]
0
0
Germany
Query!
State/province [71]
0
0
Erlangen
Query!
Country [72]
0
0
Germany
Query!
State/province [72]
0
0
Giessen
Query!
Country [73]
0
0
Germany
Query!
State/province [73]
0
0
Halle (Saale)
Query!
Country [74]
0
0
Germany
Query!
State/province [74]
0
0
Hanburg
Query!
Country [75]
0
0
Germany
Query!
State/province [75]
0
0
Heidelberg
Query!
Country [76]
0
0
Germany
Query!
State/province [76]
0
0
Koln
Query!
Country [77]
0
0
Germany
Query!
State/province [77]
0
0
Magdeburg
Query!
Country [78]
0
0
Germany
Query!
State/province [78]
0
0
Marburg
Query!
Country [79]
0
0
Germany
Query!
State/province [79]
0
0
Munchen
Query!
Country [80]
0
0
Germany
Query!
State/province [80]
0
0
Regensburg
Query!
Country [81]
0
0
Germany
Query!
State/province [81]
0
0
Schwerin
Query!
Country [82]
0
0
Greece
Query!
State/province [82]
0
0
Athens
Query!
Country [83]
0
0
Greece
Query!
State/province [83]
0
0
Larisa
Query!
Country [84]
0
0
Greece
Query!
State/province [84]
0
0
Patra
Query!
Country [85]
0
0
Greece
Query!
State/province [85]
0
0
Thessaloniki
Query!
Country [86]
0
0
India
Query!
State/province [86]
0
0
Ahmedabad
Query!
Country [87]
0
0
India
Query!
State/province [87]
0
0
Bangalore
Query!
Country [88]
0
0
India
Query!
State/province [88]
0
0
Calicut
Query!
Country [89]
0
0
India
Query!
State/province [89]
0
0
Chandigarh
Query!
Country [90]
0
0
India
Query!
State/province [90]
0
0
Chennai
Query!
Country [91]
0
0
India
Query!
State/province [91]
0
0
Cochin
Query!
Country [92]
0
0
India
Query!
State/province [92]
0
0
Coimbatore
Query!
Country [93]
0
0
India
Query!
State/province [93]
0
0
Kochi
Query!
Country [94]
0
0
India
Query!
State/province [94]
0
0
Kolkata
Query!
Country [95]
0
0
India
Query!
State/province [95]
0
0
Lucknow
Query!
Country [96]
0
0
India
Query!
State/province [96]
0
0
Ludhiana
Query!
Country [97]
0
0
India
Query!
State/province [97]
0
0
Mangalore
Query!
Country [98]
0
0
India
Query!
State/province [98]
0
0
Mumbai
Query!
Country [99]
0
0
India
Query!
State/province [99]
0
0
New Delhi
Query!
Country [100]
0
0
India
Query!
State/province [100]
0
0
Pune
Query!
Country [101]
0
0
Ireland
Query!
State/province [101]
0
0
Cork
Query!
Country [102]
0
0
Ireland
Query!
State/province [102]
0
0
Dublin
Query!
Country [103]
0
0
Ireland
Query!
State/province [103]
0
0
Galway
Query!
Country [104]
0
0
Israel
Query!
State/province [104]
0
0
Holon
Query!
Country [105]
0
0
Israel
Query!
State/province [105]
0
0
Safed
Query!
Country [106]
0
0
Latvia
Query!
State/province [106]
0
0
Riga
Query!
Country [107]
0
0
Macedonia, The Former Yugoslav Republic of
Query!
State/province [107]
0
0
Skopje
Query!
Country [108]
0
0
Mexico
Query!
State/province [108]
0
0
Jal
Query!
Country [109]
0
0
Mexico
Query!
State/province [109]
0
0
Michoacan
Query!
Country [110]
0
0
Mexico
Query!
State/province [110]
0
0
Nuevo Leon
Query!
Country [111]
0
0
Mexico
Query!
State/province [111]
0
0
Aguascalientes
Query!
Country [112]
0
0
Mexico
Query!
State/province [112]
0
0
Guadalajara
Query!
Country [113]
0
0
Mexico
Query!
State/province [113]
0
0
Mexico DF
Query!
Country [114]
0
0
Mexico
Query!
State/province [114]
0
0
Mexico
Query!
Country [115]
0
0
Mexico
Query!
State/province [115]
0
0
Monterray
Query!
Country [116]
0
0
Moldova, Republic of
Query!
State/province [116]
0
0
Chisinau
Query!
Country [117]
0
0
Moldova, Republic of
Query!
State/province [117]
0
0
Kishinev
Query!
Country [118]
0
0
New Zealand
Query!
State/province [118]
0
0
Hamilton
Query!
Country [119]
0
0
Poland
Query!
State/province [119]
0
0
Bialystok
Query!
Country [120]
0
0
Poland
Query!
State/province [120]
0
0
Gdansk
Query!
Country [121]
0
0
Poland
Query!
State/province [121]
0
0
Katowice
Query!
Country [122]
0
0
Poland
Query!
State/province [122]
0
0
Lodz
Query!
Country [123]
0
0
Poland
Query!
State/province [123]
0
0
Lublin
Query!
Country [124]
0
0
Poland
Query!
State/province [124]
0
0
Poznan
Query!
Country [125]
0
0
Poland
Query!
State/province [125]
0
0
Szczecin
Query!
Country [126]
0
0
Poland
Query!
State/province [126]
0
0
Warsaw
Query!
Country [127]
0
0
Poland
Query!
State/province [127]
0
0
Warszawa
Query!
Country [128]
0
0
Poland
Query!
State/province [128]
0
0
Wroclaw
Query!
Country [129]
0
0
Puerto Rico
Query!
State/province [129]
0
0
Guaynabo
Query!
Country [130]
0
0
Romania
Query!
State/province [130]
0
0
Bucuresti
Query!
Country [131]
0
0
Romania
Query!
State/province [131]
0
0
Iasi
Query!
Country [132]
0
0
Romania
Query!
State/province [132]
0
0
Oradea
Query!
Country [133]
0
0
Romania
Query!
State/province [133]
0
0
Tirgu Mures
Query!
Country [134]
0
0
Romania
Query!
State/province [134]
0
0
Tirgu-Mures
Query!
Country [135]
0
0
Serbia
Query!
State/province [135]
0
0
Belgrade
Query!
Country [136]
0
0
Serbia
Query!
State/province [136]
0
0
Kragujevac
Query!
Country [137]
0
0
Serbia
Query!
State/province [137]
0
0
Nis
Query!
Country [138]
0
0
Serbia
Query!
State/province [138]
0
0
Novi Sad
Query!
Country [139]
0
0
Slovakia
Query!
State/province [139]
0
0
Kosice
Query!
Country [140]
0
0
Slovakia
Query!
State/province [140]
0
0
Martin
Query!
Country [141]
0
0
Spain
Query!
State/province [141]
0
0
Barcelona
Query!
Country [142]
0
0
Spain
Query!
State/province [142]
0
0
Bilbao
Query!
Country [143]
0
0
Spain
Query!
State/province [143]
0
0
Cordoba
Query!
Country [144]
0
0
Spain
Query!
State/province [144]
0
0
Gandia
Query!
Country [145]
0
0
Spain
Query!
State/province [145]
0
0
Madrid
Query!
Country [146]
0
0
Spain
Query!
State/province [146]
0
0
Malaga
Query!
Country [147]
0
0
Spain
Query!
State/province [147]
0
0
Santiago de Compostela
Query!
Country [148]
0
0
Spain
Query!
State/province [148]
0
0
Sevilla
Query!
Country [149]
0
0
Ukraine
Query!
State/province [149]
0
0
Kharkiv
Query!
Country [150]
0
0
Ukraine
Query!
State/province [150]
0
0
Kyiv
Query!
Country [151]
0
0
Ukraine
Query!
State/province [151]
0
0
Lviv
Query!
Country [152]
0
0
Ukraine
Query!
State/province [152]
0
0
Odessa
Query!
Country [153]
0
0
Ukraine
Query!
State/province [153]
0
0
Poltava
Query!
Country [154]
0
0
Ukraine
Query!
State/province [154]
0
0
Simferopol
Query!
Country [155]
0
0
Ukraine
Query!
State/province [155]
0
0
Zaporozhye
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Biogen
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. Other goals of the study are to determine if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for MS to get worse. Other objectives of the study are to determine the safety and tolerability of BG00012, as well as the effect it may have on tests and evaluations used to assess MS. Additionally, glatiramer acetate is being used to compare its benefits and risks with placebo and BG00012.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00451451
Query!
Trial related presentations / publications
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. doi: 10.1177/1756286420968357. 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. Fox RJ, Gold R, Phillips JT, Okwuokenye M, Zhang A, Marantz JL. Efficacy and Tolerability of Delayed-release Dimethyl Fumarate in Black, Hispanic, and Asian Patients with Relapsing-Remitting Multiple Sclerosis: Post Hoc Integrated Analysis of DEFINE and CONFIRM. Neurol Ther. 2017 Dec;6(2):175-187. doi: 10.1007/s40120-017-0077-5. Epub 2017 Aug 2. Fernandez O, Giovannoni G, Fox RJ, Gold R, Phillips JT, Potts J, Okwuokenye M, Marantz JL. Efficacy and Safety of Delayed-release Dimethyl Fumarate for Relapsing-remitting Multiple Sclerosis in Prior Interferon Users: An Integrated Analysis of DEFINE and CONFIRM. Clin Ther. 2017 Aug;39(8):1671-1679. doi: 10.1016/j.clinthera.2017.06.012. Epub 2017 Jul 25. Fox RJ, Chan A, Zhang A, Xiao J, Levison D, Lewin JB, Edwards MR, Marantz JL. Comparative effectiveness using a matching-adjusted indirect comparison between delayed-release dimethyl fumarate and fingolimod for the treatment of multiple sclerosis. Curr Med Res Opin. 2017 Feb;33(2):175-183. doi: 10.1080/03007995.2016.1248380. Epub 2016 Nov 10. 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. Giovannoni G, Gold R, Fox RJ, Kappos L, Kita M, Yang M, Sarda SP, Zhang R, Viglietta V, Havrdova E. Relapses Requiring Intravenous Steroid Use and Multiple-Sclerosis-related Hospitalizations: Integrated Analysis of the Delayed-release Dimethyl Fumarate Phase III Studies. Clin Ther. 2015 Nov 1;37(11):2543-51. doi: 10.1016/j.clinthera.2015.09.011. Epub 2015 Oct 31. Fox RJ, Kita M, Cohan SL, Henson LJ, Zambrano J, Scannevin RH, O'Gorman J, Novas M, Dawson KT, Phillips JT. BG-12 (dimethyl fumarate): a review of mechanism of action, efficacy, and safety. Curr Med Res Opin. 2014 Feb;30(2):251-62. doi: 10.1185/03007995.2013.849236. Epub 2013 Oct 22. Fox RJ, Miller DH, Phillips JT, Hutchinson M, Havrdova E, Kita M, Yang M, Raghupathi K, Novas M, Sweetser MT, Viglietta V, Dawson KT; CONFIRM Study Investigators. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med. 2012 Sep 20;367(12):1087-97. doi: 10.1056/NEJMoa1206328. Erratum In: N Engl J Med. 2012 Oct 25;367(17):1673.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Medical Director
Query!
Address
0
0
Biogen
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00451451
Download to PDF