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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,736
BG00012 capsules
Capsules taken to maintain the blind in the 240 mg BID treatment group.
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.
Time frame: Day 1 up to Week 561
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline up to Week 288
Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI)
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Research Site
Birmingham, Alabama, United States
Research Site
Huntsville, Alabama, United States
research Site
Mesa, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Loma Linda, California, United States
Research Site
Boulder, Colorado, United States
Research Site
Fort Collins, Colorado, United States
Research Site
North Haven, Connecticut, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Maitland, Florida, United States
...and 236 more locations
The Gd-enhancing lesions was evaluated using MRI technique.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline up to Week 288
Percent Change From Baseline in Brain Atrophy
Brain atrophy was measured using magnetic resonance imaging (MRI) technique.
Time frame: Baseline up to Week 288
Percent Change From Baseline in Magnetization Transfer Ratio (MTR)
Magnetization Transfer Ratio (MTR) was measured using MRI technique.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 384