Clinical trial NCT00420212: Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: relapsing
oral
remitting
multiple sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2007-01-11
Enrollment: 1234
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.


Eligibility criteria: 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:
* 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:

* 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.

Primary outcomes:
measure: Proportion of Subjects Relapsed
timeFrame: 2 years
Secondary outcomes:
measure: Number of New or Newly Enlarging T2 Hyperintense Lesions
timeFrame: 2 years
measure: Number of Gadolinium-enhancing T1-weighted Lesions
timeFrame: 2 years
measure: Number of Subjects With Gadolinium (Gd)-Enhancing Lesions
timeFrame: 2 years
measure: Annualized Relapse Rate
timeFrame: 2 years
measure: Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS)
timeFrame: 2 years
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Research Site
state: Arizona
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: San Francisco
country: United States
facility: Research Site
state: California
city: New Haven
country: United States
facility: Research Site
state: Connecticut
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Vero Beach
country: United States
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state: Florida
city: Atlanta
country: United States
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state: Georgia
city: Evanston
country: United States
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state: Illinois
city: Palos Heights
country: United States
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state: Illinois
city: Fort Wayne
country: United States
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city: Indianapolis
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city: Des Moines
country: United States
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state: Iowa
city: Wichita
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state: Kansas
city: Lexington
country: United States
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state: Kentucky
city: Brighton
country: United States
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state: Massachusetts
city: Hopedale
country: United States
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state: Massachusetts
city: Lexington
country: United States
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city: Springfield
country: United States
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city: Worcester
country: United States
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city: Farmington Hills
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state: Michigan
city: Minneapolis
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city: Columbia
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state: Missouri
city: St. Louis
country: United States
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city: Henderson
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state: Nevada
city: Las Vegas
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city: Lebanon
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state: New Hampshire
city: Albany
country: United States
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city: Staten Island
country: United States
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city: Raleigh
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city: Dayton
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city: Erie
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city: Hershey
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city: Wien
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country: Australia
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state: New South Wales
city: Chatswood
country: Australia
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state: New South Wales
city: Fitzroy
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city: Geelong
country: Australia
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city: Melbourne
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city: Newcastle
country: Australia
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city: Wien
country: Austria
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state: Vienna
city: Graz
country: Austria
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city: Innsbruck
country: Austria
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city: Linz
country: Austria
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city: Antwerpen
country: Belgium
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city: Brugge
country: Belgium
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city: Charleroi
country: Belgium
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city: Diepenbeek
country: Belgium
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city: Leuven
country: Belgium
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city: Lommel
country: Belgium
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city: Sijsele-Damme
country: Belgium
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city: Woluwe
country: Belgium
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city: Banja Luka
country: Bosnia and Herzegovina
facility: Research Site
state: Republic of Srpksa
city: Burnaby
country: Canada
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state: British Columbia
city: Halifax
country: Canada
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state: Nova Scotia
city: Ottawa
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state: Ontario
city: Levis
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city: Quebec City
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city: Regina
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city: Montreal
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country: Croatia
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country: Czech Republic
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country: Czech Republic
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city: Opava
country: Czech Republic
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city: Ostrava
country: Czech Republic
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country: Czech Republic
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country: Czech Republic
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country: Czech Republic
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country: France
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city: Nice
country: France
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country: France
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city: Rennes
country: France
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city: Bad Neustadt-Saale
country: Germany
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city: Berlin
country: Germany
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country: Germany
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city: Dusseldorf
country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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city: Minden
country: Germany
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city: Munchen
country: Germany
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city: Munster
country: Germany
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city: Osnabruck
country: Germany
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city: Westerstede
country: Germany
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city: Athens
country: Greece
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country: Greece
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country: Greece
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city: Guatemala City
country: Guatemala
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country: India
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country: India
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country: Israel
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country: Israel
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country: Israel
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city: Roma
country: Italy
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country: Macedonia, The Former Yugoslav Republic of
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city: Guadalajara
country: Mexico
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city: Mexico City
country: Mexico
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city: San Luis Potosi
country: Mexico
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city: Chisinau
country: Moldova, Republic of
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city: Kishinev
country: Moldova, Republic of
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city: Breda
country: Netherlands
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city: Sittard
country: Netherlands
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city: Christchurch
country: New Zealand
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city: Grafton
country: New Zealand
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city: Hamilton
country: New Zealand
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city: Bialystok
country: Poland
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city: Gdansk
country: Poland
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city: Katowice
country: Poland
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city: Krakow
country: Poland
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city: Poznan
country: Poland
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city: Szczecin
country: Poland
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city: Warsaw
country: Poland
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city: Bucuresti
country: Romania
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city: Cluj-Napoca
country: Romania
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city: Timisoara
country: Romania
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city: Belgrade
country: Serbia
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city: Kragujevac
country: Serbia
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city: Nis
country: Serbia
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city: Novi Sad
country: Serbia
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city: Bratislava
country: Slovakia
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city: Kosice
country: Slovakia
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city: Martin
country: Slovakia
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city: Cape Town
country: South Africa
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city: Durban
country: South Africa
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city: Rosebank
country: South Africa
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city: Basel
country: Switzerland
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city: St. Gallen
country: Switzerland
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city: Zurich
country: Switzerland
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Lviv
country: Ukraine
facility: Research Site
city: Odessa
country: Ukraine
facility: Research Site
city: Poltava
country: Ukraine
facility: Research Site
city: Zaporozhye
country: Ukraine
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Newcastle
country: United Kingdom
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city: Oxford
country: United Kingdom
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city: Sheffield
country: United Kingdom
facility: Research Site
city: Staffordshire
country: United Kingdom
facility: Research Site
city: Vienna
country: Virgin Islands (U.S.)
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.
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citation: 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.
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citation: Kita 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.
citation: 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.
citation: Gold 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.