Relapsing-Remitting Multiple SclerosisPhase 3DEFINENCT00420212
Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis
A Phase 3 study testing BG00012 in people with Relapsing-Remitting Multiple Sclerosis, run by Biogen at 159 sites in 29 countries.
Trial summary
To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. 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 the disease to get worse. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis
- What is being tested?
- BG00012
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,234 participants
- Where
- 159 sitesin 29 countries
- Study dates
- Jan 2007to Feb 2011
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:
- Must have a 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.
Who cannot join
- Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at randomization:
- Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.
- Pregnant or nursing women.
- Note: Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
159 sites in 29 countries.
159 sites in 29 countries
United States39 sites
Research Site
Albany, New York
Research Site
Atlanta, Georgia
Research Site
Brighton, Massachusetts
Research Site
Columbia, Missouri
Research Site
Dayton, Ohio
Research Site
Des Moines, Iowa
Research Site
East Providence, Rhode Island
Research Site
Erie, Pennsylvania
Research Site
Evanston, Illinois
Research Site
Farmington Hills, Michigan
Research Site
Fort Wayne, Indiana
Research Site
Gilbert, Arizona
Research Site
Henderson, Nevada
Research Site
Hershey, Pennsylvania
Research Site
Hopedale, Massachusetts
Research Site
Indianapolis, Indiana
Research Site
Las Vegas, Nevada
Research Site
Lebanon, New Hampshire
Research Site
Lexington, Kentucky
Research Site
Lexington, Massachusetts
Research Site
Minneapolis, Minnesota
Research Site
New Haven, Connecticut
Research Site
Newport News, Virginia
Research Site
Palos Heights, Illinois
Research Site
Phoenix, Arizona
Research Site
Pittsburgh, Pennsylvania
Research Site
Providence, Rhode Island
Research Site
Raleigh, North Carolina
Research Site
San Antonio, Texas
Research Site
San Francisco, California
Research Site
Seattle, Washington
Research Site
Springfield, Massachusetts
Research Site
St Louis, Missouri
Research Site
Staten Island, New York
Research Site
Vero Beach, Florida
Research Site
Washington D.C., District of Columbia
Research Site
Wichita, Kansas
Research Site
Wien, Virginia
Research Site
Worcester, Massachusetts
Germany15 sites
Research Site
Bad Neustadt-Saale
Research Site
Berlin
Research Site
Bochum
Research Site
Düsseldorf
Research Site
Essen
Research Site
Gieben
Research Site
Halle
Research Site
Hamburg
Research Site
Hanover
Research Site
Leipzig
Research Site
Minden
Research Site
München
Research Site
Münster
Research Site
Osnabrück
Research Site
Westerstede
India10 sites
Research Site
Chenna
Research Site
Coimbatore
Research Site
Delhi
Research Site
Hyderabad
Research Site
Kolkata
Research Site
Lucknow
Research Site
Mangalore
Research Site
Mumbai
Research Site
New Delhi
Research Site
Pune
Australia9 sites
Research Site
Camperdown, New South Wales
Research Site
Chatswood, New South Wales
Research Site
Fitzroy
Research Site
Geelong
Research Site
Heidelberg
Research Site
Kogarah
Research Site
Liverpool
Research Site
Melbourne
Research Site
Newcastle
Belgium8 sites
Research Site
Antwerp
Research Site
Bruges
Research Site
Charleroi
Research Site
Diepenbeek
Research Site
Leuven
Research Site
Lommel
Research Site
Sijsele-Damme
Research Site
Woluwe
Canada7 sites
Research Site
Burnaby, British Columbia
Research Site
Halifax, Nova Scotia
Research Site
Lévis, Quebec
Research Site
Montreal
Research Site
Ottawa, Ontario
Research Site
Québec, Quebec
Research Site
Regina, Saskatchewan
Czechia7 sites
Research Site
Brno
Research Site
Jihlava
Research Site
Opava
Research Site
Ostrava
Research Site
Pilsen
Research Site
Prague
Research Site
Teplice
Poland7 sites
Research Site
Bialystok
Research Site
Gdansk
Research Site
Katowice
Research Site
Krakow
Research Site
Poznan
Research Site
Szczecin
Research Site
Warsaw
Ukraine6 sites
Research Site
Kharkiv
Research Site
Kyiv
Research Site
Lviv
Research Site
Odesa
Research Site
Poltava
Research Site
Zaporizhzhya
United Kingdom5 sites
Research Site
London
Research Site
Newcastle
Research Site
Oxford
Research Site
Sheffield
Research Site
Staffordshire
Austria4 sites
Research Site
Graz
Research Site
Innsbruck
Research Site
Linz
Research Site
Vienna, State of Vienna
France4 sites
Research Site
Clermont-Ferrand
Research Site
Nice
Research Site
Paris
Research Site
Rennes
Israel4 sites
Research Site
Ashkelon
Research Site
Beer Yaakov
Research Site
Jerusalem
Research Site
Tel HaShomer
Serbia4 sites
Research Site
Belgrade
Research Site
Kragujevac
Research Site
Niš
Research Site
Novi Sad
Greece3 sites
Research Site
Athens
Research Site
Ioannina
Research Site
Thessaloniki
Mexico3 sites
Research Site
Guadalajara
Research Site
Mexico City
Research Site
San Luis Potosí City
New Zealand3 sites
Research Site
Christchurch
Research Site
Grafton
Research Site
Hamilton
Romania3 sites
Research Site
Bucharest
Research Site
Cluj-Napoca
Research Site
Timișoara
Slovakia3 sites
Research Site
Bratislava
Research Site
Košice
Research Site
Martin
South Africa3 sites
Research Site
Cape Town
Research Site
Durban
Research Site
Rosebank
Switzerland3 sites
Research Site
Basel
Research Site
Sankt Gallen
Research Site
Zurich
Bosnia and Herzegovina1 site
Research Site
Banja Luka, Republic of Srpksa
Virgin Islands1 site
Research Site
Vienna
About this study
Official title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis
To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. 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 the disease to get worse.
The purpose of this study is also to determine the safety of BG00012 and how well it is tolerated. Another goal is to see what effect BG00012 may have on tests and evaluations used to assess MS.
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Being tested
- BG00012, Placebo
- Keywords
- relapsing, oral, remitting, multiple sclerosis
- 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.
BG00012Drug
Also called dimethyl fumarate, Tecfidera®
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received two placebo capsules orally three times daily (TID) Receives: Drug: Placebo |
| BG00012 240 mg Twice Daily (BID) | Experimental | Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD) Receives: Drug: BG00012 |
| BG00012 240 mg 3 Times Daily (TID) | Experimental | Participants received two 120 mg BG00012 capsules orally three times daily (TID) Receives: Drug: BG00012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects Relapsed
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 neurolgic 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.
Measured: 2 years
Secondary outcomes (5)
Number of New or Newly Enlarging T2 Hyperintense Lesions
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 lesion count were calculated from a negative binomial regression model adjusted for region and baselineT2 lesion volume
Measured: 2 years
Number of Gadolinium-enhancing T1-weighted Lesions
The number of Gd-enhancing lesions was assessed using brain MRI scans following administration of gadolinium, a contrast agent. The mean number of Gd-enhancing lesions at 2 years was the average of the number of lesions at 2 years in a treatment group.
Measured: 2 years
Number of Subjects With Gadolinium (Gd)-Enhancing Lesions
Note: This outcome measure represents the categorical analysis for the previously listed secondary outcome measure "Number of Gadolinium-enhancing T1-weighted lesions"
Measured: 2 years
Annualized Relapse Rate
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 EDSS (≤ 2.0 vs. >2.0), age (<40 versus ≥40 years), region, and the number of relapses in the 1 year prior to enrollment.
Measured: 2 years
Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS)
The EDSS is based on a standardized neurological examination and focuses on symptoms that commonly occur in MS. EDSS 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 a ≥1.5 point increase in subjects with a baseline EDSS = 0, and required that the increase from baseline was confirmed ≥12 weeks 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionFeb 2011
- Study completionFeb 2011
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 (11)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, Investigator
- Enrolment
- 1,234 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
- NCT00420212
- Sponsor's protocol ID
- 109MS301
- Acronym
- DEFINE
- Status last verified
- Jan 2015
- First submitted
- 8 Jan 2007
- Last updated
- 26 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
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 30918100Fox 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.
PubMed 28770420Fernandez 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.
PubMed 28751099Fox 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.
PubMed 27733070Gold 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 26932146Giovannoni 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.
PubMed 26526385Nakamura K, Brown RA, Narayanan S, Collins DL, Arnold DL; Alzheimer's Disease Neuroimaging Initiative. Diurnal fluctuations in brain volume: Statistical analyses of MRI from large populations. Neuroimage. 2015 Sep;118:126-32. doi: 10.1016/j.neuroimage.2015.05.077. Epub 2015 Jun 3.
PubMed 26049148Kita M, Fox RJ, Gold R, Giovannoni G, Phillips JT, Sarda SP, Kong J, Viglietta V, Sheikh SI, Okwuokenye M, Kappos L. Effects of delayed-release dimethyl fumarate (DMF) on health-related quality of life in patients with relapsing-remitting multiple sclerosis: an integrated analysis of the phase 3 DEFINE and CONFIRM studies. Clin Ther. 2014 Dec 1;36(12):1958-1971. doi: 10.1016/j.clinthera.2014.08.013. Epub 2014 Oct 12.
PubMed 25315404Fox 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.
PubMed 24131282Gold R, Kappos L, Arnold DL, Bar-Or A, Giovannoni G, Selmaj K, Tornatore C, Sweetser MT, Yang M, Sheikh SI, Dawson KT; DEFINE Study Investigators. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med. 2012 Sep 20;367(12):1098-107. doi: 10.1056/NEJMoa1114287.
PubMed 22992073
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00420212
- Acronym / sponsor ID
- DEFINE / 109MS301
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Keywords
- relapsing, oral, remitting, multiple sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,234 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 11 Jan 2007 (estimated)
- Results
- Posted 2 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. 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 the disease to get worse.
The purpose of this study is also to determine the safety of BG00012 and how well it is tolerated. Another goal is to see what effect BG00012 may have on tests and evaluations used to assess MS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants received two placebo capsules orally three times daily (TID) |
| BG00012 240 mg Twice Daily (BID) | Experimental | Drug: BG00012Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD) |
| BG00012 240 mg 3 Times Daily (TID) | Experimental | Drug: BG00012Participants received two 120 mg BG00012 capsules orally three times daily (TID) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:
- Must have a 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 exclusion criteria (4 listed)
- Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at randomization:
- Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.
- Pregnant or nursing women.
- 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 |
|---|---|---|
| BG00012Also: dimethyl fumarate, Tecfidera® | Drug | BG00012 240 mg 3 Times Daily (TID), BG00012 240 mg Twice Daily (BID) |
| Placebo | Drug | Placebo |
Primary outcome
Proportion of Subjects Relapsed
Time frame: 2 years
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 neurolgic 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.
5 secondary outcomes
Number of New or Newly Enlarging T2 Hyperintense Lesions
Time frame: 2 years
Number of Gadolinium-enhancing T1-weighted Lesions
Time frame: 2 years
Number of Subjects With Gadolinium (Gd)-Enhancing Lesions
Time frame: 2 years
Annualized Relapse Rate
Time frame: 2 years
Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS)
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 28770420Fox 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.
- Derived from this study: PubMed 28751099Fernandez 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.
- Derived from this study: PubMed 27733070Fox 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.
- 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.
- Derived from this study: PubMed 26526385Giovannoni 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.
- Derived from this study: PubMed 26049148Nakamura K, Brown RA, Narayanan S, Collins DL, Arnold DL; Alzheimer's Disease Neuroimaging Initiative. Diurnal fluctuations in brain volume: Statistical analyses of MRI from large populations. Neuroimage. 2015 Sep;118:126-32. doi: 10.1016/j.neuroimage.2015.05.077. Epub 2015 Jun 3.
- Derived from this study: PubMed 25315404Kita M, Fox RJ, Gold R, Giovannoni G, Phillips JT, Sarda SP, Kong J, Viglietta V, Sheikh SI, Okwuokenye M, Kappos L. Effects of delayed-release dimethyl fumarate (DMF) on health-related quality of life in patients with relapsing-remitting multiple sclerosis: an integrated analysis of the phase 3 DEFINE and CONFIRM studies. Clin Ther. 2014 Dec 1;36(12):1958-1971. doi: 10.1016/j.clinthera.2014.08.013. Epub 2014 Oct 12.
- Derived from this study: PubMed 24131282Fox 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.
- Derived from this study: PubMed 22992073Gold R, Kappos L, Arnold DL, Bar-Or A, Giovannoni G, Selmaj K, Tornatore C, Sweetser MT, Yang M, Sheikh SI, Dawson KT; DEFINE Study Investigators. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med. 2012 Sep 20;367(12):1098-107. doi: 10.1056/NEJMoa1114287.
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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
159 sites in 29 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BG00012 in people with Relapsing-Remitting Multiple Sclerosis, run by Biogen at 159 sites in 29 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 4 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 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 159 sites in United States, Germany, India, Australia, Belgium and 24 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. Some participants in this study may receive a placebo. 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 2 Jun 2014). 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?
Proportion of Subjects Relapsed (time frame: 2 years). 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 NCT00420212, which also lists 11 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 26 Jan 2015.