Clinical trial NCT01838668: An Efficacy and Safety Study of BG00012 (Dimethyl Fumarate) in Asian Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of BG00012 in Subjects From the Asia-Pacific Region and Other Countries With Relapsing-Remitting Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Relapsing-Remitting Multiple Sclerosis
Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2013-04-24
Enrollment: 225
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: This is a multicenter study conducted in 2 parts:

The primary objective in Part I of this study is to determine the efficacy of BG00012 (dimethyl fumarate, DMF) on inflammatory brain magnetic resonance imaging (MRI) lesion activity (Gadolinium-enhancing lesions) when compared with placebo from 4 scans performed at Weeks 12, 16, 20, and 24 in participants with Relapsing Remitting Multiple Sclerosis (RRMS) including participants from the Asia-Pacific region.

The secondary objectives in Part I of this study in this study population are to determine whether BG00012, when compared with placebo over 24 weeks, is effective in reducing the cumulative number of new Gadolinium-enhancing lesions from Baseline to Week 24; reducing the number of new or newly enlarging T2 hyperintense lesions on brain MRI scans at Week 24 compared with Baseline.

The primary objective in Part II (open label) of this study is to evaluate the long-term safety profile of BG00012 in eligible participants from Part I.


Eligibility criteria: Key Inclusion Criteria:

* Inclusion Criteria for Part I:

  * Must have a diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS).
  * Must have a baseline Expanded Disability Status Scale (EDSS) score between 0.0 and 5.0, inclusive.

Key Inclusion Criteria for Part II:

• Subjects who participated in and completed Part I per protocol.

Key Exclusion Criteria:

* 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: Total number of new Gadolinium-enhancing lesions over 4 scans at Weeks 12, 16, 20, and 24.
timeFrame: Part I (Week 24)
measure: Incidence of treatment-emergent adverse events and serious adverse events
timeFrame: Part II (Up to 4.5 years)
Secondary outcomes:
measure: Cumulative number of new Gadolinium-enhancing lesions from Baseline to Week 24
timeFrame: Part I (Week 24)
measure: Number of new or newly enlarging T2 hyperintense lesions at Week 24 compared with Baseline
timeFrame: Part I (Week 24)
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny v Brne
city: Havirov
country: Czechia
facility: Neurospol, s.r.o.
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Hradec Kralove
country: Czechia
facility: Privatni ordinace - neurologie
city: Jihlava
country: Czechia
facility: Nemocnice Jihlava
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Praha 2
country: Czechia
facility: Fakultni poliklinika VFN
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole
city: Teplice
country: Czechia
facility: Krajska zdravotni, a.s. - Nemocnice Teplice, o.z.
city: Asahikawa-shi
country: Japan
facility: NHO Asahikawa Medical Center
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
city: Chiba-shi
country: Japan
facility: Chiba University Hospital
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital
city: Kahoku-gun
country: Japan
facility: Kanazawa Medical University Hospital
city: Kawagoe-shi
country: Japan
facility: Saitama Medical Center
city: Kobe-shi
country: Japan
facility: Kobe University Hospital
city: Kodaira-shi
country: Japan
facility: National Center Hospital, NCNP
city: Kyoto-shi
country: Japan
facility: Kyoto University Hospital
city: Kyoto-shi
country: Japan
facility: NHO Utano Hospital
city: Morioka-shi
country: Japan
facility: Iwate Medical University Hospital
city: Niigata-shi
country: Japan
facility: Niigata University Medical & Dental Hospital
city: Osaka-shi
country: Japan
facility: Irino Clinic, Inc.
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital
city: Ota-ku
country: Japan
facility: Tokyotohokeniryokosya Ebara Hospital
city: Sapporo-shi
country: Japan
facility: NHO Hokkaido Medical Center
city: Sapporo-shi
country: Japan
facility: CEReS Sapporo Neurology Clinic
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital
city: Shinjuku-ku
country: Japan
facility: Department of Neurosurgery, Tokyo Women's Medical University
city: Suita-shi
country: Japan
facility: Osaka University Hospital
city: Tokorozawa-shi
country: Japan
facility: National Defense Medical College Hospital
city: Toon-shi
country: Japan
facility: Ehime University Hospital
city: Tsukuba-shi
country: Japan
facility: Tsukuba University Hospital
city: Ube-shi
country: Japan
facility: Yamaguchi University Hospital
city: Yachiyo-shi
country: Japan
facility: Tokyo Womens Medical University Yachiyo Medical Center
city: Yokohama-shi
country: Japan
facility: Yokohama City University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Gdansk
country: Poland
facility: Copernicus Podmiot Leczniczy Sp. z o.o.
city: Katowice
country: Poland
facility: M.A. - LEK A.M.Maciejowscy SC.
city: Katowice
country: Poland
facility: Nzoz Novo-Med
city: Katowice
country: Poland
facility: Neuro-Care Gabriela Klodowska
city: Krakow
country: Poland
facility: MCD Medical
city: Lodz
country: Poland
facility: Centrum Neurologii K. Selmaj
city: Plewiska
country: Poland
facility: Neurologiczny NZOZ Centrum Leczenia SM
city: Poznan
country: Poland
facility: NZOZ "NEURO-KARD", "Ilkowski i Partnerzy" Sp. Partn. Lek.
city: Warszawa
country: Poland
facility: Miedzyleski Szpital Specjalistyczny
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Kondo T, Kawachi I, Onizuka Y, Hiramatsu K, Hase M, Yun J, Matta A, Torii S. Efficacy of dimethyl fumarate in Japanese multiple sclerosis patients: interim analysis of randomized, double-blind APEX study and its open-label extension. Mult Scler J Exp Transl Clin. 2019 Jul 31;5(3):2055217319864974. doi: 10.1177/2055217319864974. eCollection 2019 Jul-Sep.
citation: Saida T, Yamamura T, Kondo T, Yun J, Yang M, Li J, Mahadavan L, Zhu B, Sheikh SI. A randomized placebo-controlled trial of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis from East Asia and other countries. BMC Neurol. 2019 Jan 7;19(1):5. doi: 10.1186/s12883-018-1220-3.
citation: Ochi H, Niino M, Onizuka Y, Hiramatsu K, Hase M, Yun J, Matta A, Torii S. 72-Week Safety and Tolerability of Dimethyl Fumarate in Japanese Patients with Relapsing-remitting Multiple Sclerosis: Analysis of the Randomised, Double Blind, Placebo-Controlled, Phase III APEX Study and its Open-Label Extension. Adv Ther. 2018 Oct;35(10):1598-1611. doi: 10.1007/s12325-018-0788-8. Epub 2018 Sep 11.