Relapsing-Remitting Multiple Sclerosis
Conditions
Keywords
relapsing, multiple sclerosis, remitting, oral
Brief summary
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.
Detailed description
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.
Interventions
DRUGdimethyl fumarate
BG00012 capsules
DRUGPlacebo
Capsules taken to maintain the blind in the 240 mg BID treatment group.
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 58 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: -Subjects who participated in and completed as per protocol previous BG00012 clinical studies 109MS301 (NCT00420212) or 109MS302 (NCT00451451). Key
Exclusion criteria
* Any significant change in medical history from 109MS301 or 109MS302 that would have excluded subject's participation from their previous study. * Subjects from 109MS301 or 109MS302 who discontinued oral study treatment due to an AE or due to reasons other than protocol-defined relapse/disability progression. * Subjects from 109MS301 or 109MS302 who discontinued study treatment due to disability progression or relapses and did not follow the modified visit schedule up to Week 96. NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) | Day 1 up to Week 561 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Annualized Relapse Rate (ARR) | Day 1 up to Week 384 | 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. |
| Change From Baseline in the Expanded Disability Status Scale (EDSS) at Week 384 | Baseline, 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. |
| Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline up to Week 288 | The Gd-enhancing lesions was evaluated using MRI technique. |
| Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline up to Week 288 | The Gd-enhancing lesions was evaluated using MRI technique. |
| Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline up to Week 288 | The T2 lesions was evaluated using MRI technique. |
| Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline up to Week 288 | The T2 lesions was evaluated using MRI technique. |
| Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline up to Week 288 | The T1 hypointense lesions was evaluated using MRI technique. |
| Percentage of Participants Who Had Relapses | Day 1 up to Week 384 | Relapses were defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours. |
| Percent Change From Baseline in Brain Atrophy | Baseline up to Week 288 | Brain atrophy was measured using magnetic resonance imaging (MRI) technique. |
| Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Baseline up to Week 288 | Magnetization Transfer Ratio (MTR) was measured using MRI technique. |
| Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline, 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. |
| Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - EQ-5D Index Score at Week 384 | Baseline, 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. |
| Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - Visual Analog Scale (VAS) at Week 384 | Baseline, 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. |
| Change From Baseline in Visual Function Test Scores at Week 384 | Baseline, 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. |
| Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline up to Week 288 | The T1 hypointense lesions was evaluated using MRI technique. |
Countries
Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Czechia, Estonia, France, Germany, Greece, India, Ireland, Israel, Italy, Latvia, Mexico, Moldova, Netherlands, New Zealand, North Macedonia, Poland, Puerto Rico, Romania, Serbia, Slovakia, South Africa, Spain, Switzerland, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled at 298 investigative sites from 03 February 2009 to 08 November 2019.
Pre-assignment details
The study included participants who completed studies NCT00420212 and NCT00451451. A total of 1736 participants were treated in the open label phase extension study NCT00835770, out of which 759 completed the study.
Participants by arm
| Arm | Count |
|---|---|
| BG00012 240 mg BID Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. | 868 |
| BG00012 240 mg TID Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. | 868 |
| Total | 1,736 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 113 | 124 |
| Overall Study | Consent Withdrawn | 144 | 156 |
| Overall Study | Death | 4 | 6 |
| Overall Study | Investigator Decision | 42 | 42 |
| Overall Study | Lost to Follow-up | 22 | 19 |
| Overall Study | MS Progression | 14 | 9 |
| Overall Study | MS Relapse | 17 | 23 |
| Overall Study | Other | 115 | 104 |
| Overall Study | Participant Non-Compliance | 11 | 9 |
Baseline characteristics
| Characteristic | BG00012 240 mg BID | BG00012 240 mg TID | Total |
|---|---|---|---|
| Age, Continuous | 39.6 years STANDARD_DEVIATION 8.93 | 40.1 years STANDARD_DEVIATION 9.23 | 39.8 years STANDARD_DEVIATION 9.08 |
| Race/Ethnicity, Customized Asian | 82 Participants | 80 Participants | 162 Participants |
| Race/Ethnicity, Customized Black or African American | 10 Participants | 16 Participants | 26 Participants |
| Race/Ethnicity, Customized Not Reported Due To Confidentiality Regulations | 459 Participants | 439 Participants | 898 Participants |
| Race/Ethnicity, Customized Other | 32 Participants | 24 Participants | 56 Participants |
| Race/Ethnicity, Customized White | 285 Participants | 309 Participants | 594 Participants |
| Sex: Female, Male Female | 616 Participants | 596 Participants | 1212 Participants |
| Sex: Female, Male Male | 252 Participants | 272 Participants | 524 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 868 | 6 / 868 |
| other Total, other adverse events | 779 / 868 | 767 / 868 |
| serious Total, serious adverse events | 279 / 868 | 272 / 868 |
Outcome results
Primary
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
Population: Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BG00012 240 mg BID | Number of Participants With Treatment-Emergent Adverse Events (AEs) | 824 Participants |
| BG00012 240 mg TID | Number of Participants With Treatment-Emergent Adverse Events (AEs) | 814 Participants |
Secondary
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
Population: ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BG00012 240 mg BID | Annualized Relapse Rate (ARR) | 0.159 relapses per participant-years |
| BG00012 240 mg TID | Annualized Relapse Rate (ARR) | 0.179 relapses per participant-years |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Annualized Relapse Rate (ARR) | 0.200 relapses per participant-years |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Annualized Relapse Rate (ARR) | 0.199 relapses per participant-years |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Annualized Relapse Rate (ARR) | 0.184 relapses per participant-years |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Annualized Relapse Rate (ARR) | 0.212 relapses per participant-years |
Secondary
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
Population: ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BG00012 240 mg BID | Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - EQ-5D Index Score at Week 384 | Baseline | 0.73 score on a scale | Standard Deviation 0.21 |
| BG00012 240 mg BID | Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - EQ-5D Index Score at Week 384 | Change at Week 384 | 0.01 score on a scale | Standard Deviation 0.251 |
| BG00012 240 mg TID | Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - EQ-5D Index Score at Week 384 | Baseline | 0.73 score on a scale | Standard Deviation 0.222 |
| BG00012 240 mg TID | Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - EQ-5D Index Score at Week 384 | Change at Week 384 | 0.00 score on a scale | Standard Deviation 0.233 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - EQ-5D Index Score at Week 384 | Baseline | 0.72 score on a scale | Standard Deviation 0.223 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - EQ-5D Index Score at Week 384 | Change at Week 384 | -0.07 score on a scale | Standard Deviation 0.269 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - EQ-5D Index Score at Week 384 | Baseline | 0.71 score on a scale | Standard Deviation 0.244 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - EQ-5D Index Score at Week 384 | Change at Week 384 | 0.00 score on a scale | Standard Deviation 0.249 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - EQ-5D Index Score at Week 384 | Baseline | 0.71 score on a scale | Standard Deviation 0.246 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - EQ-5D Index Score at Week 384 | Change at Week 384 | -0.04 score on a scale | Standard Deviation 0.253 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - EQ-5D Index Score at Week 384 | Baseline | 0.72 score on a scale | Standard Deviation 0.189 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - EQ-5D Index Score at Week 384 | Change at Week 384 | -0.03 score on a scale | Standard Deviation 0.241 |
Secondary
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
Population: ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BG00012 240 mg BID | Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - Visual Analog Scale (VAS) at Week 384 | Baseline | 70.97 score on a scale | Standard Deviation 18.46 |
| BG00012 240 mg BID | Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - Visual Analog Scale (VAS) at Week 384 | Change at Week 384 | -0.48 score on a scale | Standard Deviation 19.631 |
| BG00012 240 mg TID | Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - Visual Analog Scale (VAS) at Week 384 | Baseline | 70.48 score on a scale | Standard Deviation 19.993 |
| BG00012 240 mg TID | Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - Visual Analog Scale (VAS) at Week 384 | Change at Week 384 | -1.67 score on a scale | Standard Deviation 18.855 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - Visual Analog Scale (VAS) at Week 384 | Baseline | 70.40 score on a scale | Standard Deviation 17.63 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - Visual Analog Scale (VAS) at Week 384 | Change at Week 384 | -7.24 score on a scale | Standard Deviation 18.419 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - Visual Analog Scale (VAS) at Week 384 | Baseline | 69.44 score on a scale | Standard Deviation 19.907 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - Visual Analog Scale (VAS) at Week 384 | Change at Week 384 | -3.17 score on a scale | Standard Deviation 22.003 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - Visual Analog Scale (VAS) at Week 384 | Baseline | 66.80 score on a scale | Standard Deviation 18.846 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - Visual Analog Scale (VAS) at Week 384 | Change at Week 384 | -1.71 score on a scale | Standard Deviation 25.33 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - Visual Analog Scale (VAS) at Week 384 | Baseline | 69.07 score on a scale | Standard Deviation 20.094 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - Visual Analog Scale (VAS) at Week 384 | Change at Week 384 | -4.11 score on a scale | Standard Deviation 16.27 |
Secondary
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
Population: ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BG00012 240 mg BID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Mental Health Score | 1.32 score on a scale | Standard Deviation 19.715 |
| BG00012 240 mg BID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: General Health Score | 0.87 score on a scale | Standard Deviation 18.744 |
| BG00012 240 mg BID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: General Health Score | 53.99 score on a scale | Standard Deviation 21.563 |
| BG00012 240 mg BID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Vitality Score | 1.11 score on a scale | Standard Deviation 19.857 |
| BG00012 240 mg BID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Bodily-Pain Score | 69.68 score on a scale | Standard Deviation 25.587 |
| BG00012 240 mg BID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Role-Physical Score | 56.46 score on a scale | Standard Deviation 41.254 |
| BG00012 240 mg BID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Mental Component Score | 45.40 score on a scale | Standard Deviation 11.13 |
| BG00012 240 mg BID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Mental Health Score | 65.01 score on a scale | Standard Deviation 19.818 |
| BG00012 240 mg BID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Mental Component Score | 0.05 score on a scale | Standard Deviation 12.415 |
| BG00012 240 mg BID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Physical Functioning Score | 0.73 score on a scale | Standard Deviation 21.972 |
| BG00012 240 mg BID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Bodily-Pain Score | 1.32 score on a scale | Standard Deviation 28.525 |
| BG00012 240 mg BID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Physical Component Score | 0.55 score on a scale | Standard Deviation 9.373 |
| BG00012 240 mg BID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Role-Emotional Score | 64.87 score on a scale | Standard Deviation 40.653 |
| BG00012 240 mg BID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Role-Emotional Score | 0.43 score on a scale | Standard Deviation 49.95 |
| BG00012 240 mg BID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Vitality Score | 50.48 score on a scale | Standard Deviation 20.966 |
| BG00012 240 mg BID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Physical Functioning Score | 68.48 score on a scale | Standard Deviation 25.938 |
| BG00012 240 mg BID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Social Functioning Score | -2.16 score on a scale | Standard Deviation 25.575 |
| BG00012 240 mg BID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Physical Component Score | 43.53 score on a scale | Standard Deviation 9.884 |
| BG00012 240 mg BID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Role-Physical Score | 3.20 score on a scale | Standard Deviation 48.259 |
| BG00012 240 mg BID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Social Functioning Score | 71.46 score on a scale | Standard Deviation 24.451 |
| BG00012 240 mg TID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Role-Emotional Score | 0.47 score on a scale | Standard Deviation 43.513 |
| BG00012 240 mg TID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Social Functioning Score | 71.53 score on a scale | Standard Deviation 24.394 |
| BG00012 240 mg TID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Social Functioning Score | -3.30 score on a scale | Standard Deviation 24.912 |
| BG00012 240 mg TID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Role-Emotional Score | 65.57 score on a scale | Standard Deviation 40.015 |
| BG00012 240 mg TID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Role-Physical Score | 58.42 score on a scale | Standard Deviation 41.28 |
| BG00012 240 mg TID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Physical Functioning Score | 71.78 score on a scale | Standard Deviation 24.849 |
| BG00012 240 mg TID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Physical Component Score | 44.44 score on a scale | Standard Deviation 10.048 |
| BG00012 240 mg TID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Role-Physical Score | -2.75 score on a scale | Standard Deviation 47.283 |
| BG00012 240 mg TID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Mental Component Score | 0.87 score on a scale | Standard Deviation 10.028 |
| BG00012 240 mg TID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Bodily-Pain Score | 70.42 score on a scale | Standard Deviation 24.688 |
| BG00012 240 mg TID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Physical Component Score | -1.94 score on a scale | Standard Deviation 10.532 |
| BG00012 240 mg TID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Bodily-Pain Score | -1.47 score on a scale | Standard Deviation 25.779 |
| BG00012 240 mg TID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Mental Component Score | 45.63 score on a scale | Standard Deviation 10.272 |
| BG00012 240 mg TID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: General Health Score | 55.44 score on a scale | Standard Deviation 20.768 |
| BG00012 240 mg TID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Physical Functioning Score | -4.79 score on a scale | Standard Deviation 24.641 |
| BG00012 240 mg TID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Mental Health Score | 2.31 score on a scale | Standard Deviation 18.095 |
| BG00012 240 mg TID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: General Health Score | -2.12 score on a scale | Standard Deviation 20.595 |
| BG00012 240 mg TID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Vitality Score | 52.21 score on a scale | Standard Deviation 19.842 |
| BG00012 240 mg TID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Mental Health Score | 66.24 score on a scale | Standard Deviation 19.06 |
| BG00012 240 mg TID | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Vitality Score | -0.73 score on a scale | Standard Deviation 19.033 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Mental Health Score | -3.91 score on a scale | Standard Deviation 19.897 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Social Functioning Score | 69.67 score on a scale | Standard Deviation 24.581 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Physical Component Score | -2.29 score on a scale | Standard Deviation 8.929 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Vitality Score | -4.67 score on a scale | Standard Deviation 17.934 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: General Health Score | -2.28 score on a scale | Standard Deviation 16.752 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Physical Functioning Score | -7.37 score on a scale | Standard Deviation 22.253 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Role-Physical Score | -10.00 score on a scale | Standard Deviation 43.188 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Mental Health Score | 65.42 score on a scale | Standard Deviation 17.658 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Role-Physical Score | 56.35 score on a scale | Standard Deviation 40.896 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Physical Component Score | 43.74 score on a scale | Standard Deviation 9.739 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Vitality Score | 50.63 score on a scale | Standard Deviation 19.13 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Physical Functioning Score | 69.67 score on a scale | Standard Deviation 24.481 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Bodily-Pain Score | -2.92 score on a scale | Standard Deviation 23.486 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Mental Component Score | 45.13 score on a scale | Standard Deviation 10.932 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Role-Emotional Score | -12.22 score on a scale | Standard Deviation 42.532 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Bodily-Pain Score | 68.51 score on a scale | Standard Deviation 26.163 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Mental Component Score | -2.55 score on a scale | Standard Deviation 10.328 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Role-Emotional Score | 62.86 score on a scale | Standard Deviation 42.715 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: General Health Score | 54.45 score on a scale | Standard Deviation 18.69 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Social Functioning Score | -5.69 score on a scale | Standard Deviation 22.184 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Role-Emotional Score | 62.61 score on a scale | Standard Deviation 41.28 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Physical Functioning Score | 67.97 score on a scale | Standard Deviation 26.279 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Physical Functioning Score | -6.89 score on a scale | Standard Deviation 23.194 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Role-Physical Score | 59.87 score on a scale | Standard Deviation 41.747 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Role-Physical Score | -8.24 score on a scale | Standard Deviation 53.177 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Bodily-Pain Score | 69.44 score on a scale | Standard Deviation 26.016 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Bodily-Pain Score | -4.36 score on a scale | Standard Deviation 25.935 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: General Health Score | 52.42 score on a scale | Standard Deviation 20.028 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: General Health Score | -0.52 score on a scale | Standard Deviation 22.035 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Vitality Score | 50.64 score on a scale | Standard Deviation 21.069 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Vitality Score | 0.40 score on a scale | Standard Deviation 20.822 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Social Functioning Score | 72.23 score on a scale | Standard Deviation 24.699 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Social Functioning Score | -2.08 score on a scale | Standard Deviation 27.724 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Role-Emotional Score | 4.17 score on a scale | Standard Deviation 44.656 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Mental Health Score | 65.15 score on a scale | Standard Deviation 19.233 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Mental Health Score | 2.33 score on a scale | Standard Deviation 17.524 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Mental Component Score | 45.31 score on a scale | Standard Deviation 10.907 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Mental Component Score | 1.97 score on a scale | Standard Deviation 10.657 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Physical Component Score | 43.56 score on a scale | Standard Deviation 10.267 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Physical Component Score | -3.25 score on a scale | Standard Deviation 9.998 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Vitality Score | -6.71 score on a scale | Standard Deviation 20.236 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Role-Emotional Score | -13.18 score on a scale | Standard Deviation 42.501 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Vitality Score | 51.30 score on a scale | Standard Deviation 19.703 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Physical Functioning Score | -6.19 score on a scale | Standard Deviation 21.719 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Mental Health Score | 62.30 score on a scale | Standard Deviation 17.347 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: General Health Score | -5.64 score on a scale | Standard Deviation 18.27 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: General Health Score | 51.21 score on a scale | Standard Deviation 18.707 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Mental Health Score | -0.29 score on a scale | Standard Deviation 21.989 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Bodily-Pain Score | -3.60 score on a scale | Standard Deviation 22.138 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Physical Functioning Score | 69.10 score on a scale | Standard Deviation 25.226 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Mental Component Score | 44.00 score on a scale | Standard Deviation 10.702 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Bodily-Pain Score | 69.30 score on a scale | Standard Deviation 25.766 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Role-Physical Score | -12.21 score on a scale | Standard Deviation 40.595 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Mental Component Score | -2.59 score on a scale | Standard Deviation 12.895 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Role-Physical Score | 55.26 score on a scale | Standard Deviation 40.39 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Physical Component Score | -2.70 score on a scale | Standard Deviation 8.86 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Physical Component Score | 43.68 score on a scale | Standard Deviation 10.359 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Social Functioning Score | -10.76 score on a scale | Standard Deviation 34.35 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Role-Emotional Score | 60.29 score on a scale | Standard Deviation 41.393 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Social Functioning Score | 69.02 score on a scale | Standard Deviation 24.688 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Physical Functioning Score | -6.25 score on a scale | Standard Deviation 28.35 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Physical Component Score | 43.15 score on a scale | Standard Deviation 10.091 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Mental Component Score | 45.03 score on a scale | Standard Deviation 10.642 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Role-Emotional Score | -3.55 score on a scale | Standard Deviation 48.769 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Vitality Score | 50.33 score on a scale | Standard Deviation 20.019 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Social Functioning Score | 69.53 score on a scale | Standard Deviation 25.1 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: General Health Score | 1.21 score on a scale | Standard Deviation 21.674 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Role-Physical Score | -1.04 score on a scale | Standard Deviation 54.568 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Vitality Score | 1.03 score on a scale | Standard Deviation 19.829 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Mental Health Score | 63.61 score on a scale | Standard Deviation 18.414 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Physical Component Score | -1.59 score on a scale | Standard Deviation 10.765 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: General Health Score | 52.58 score on a scale | Standard Deviation 19.675 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Social Functioning Score | -0.52 score on a scale | Standard Deviation 25.78 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Physical Functioning Score | 68.20 score on a scale | Standard Deviation 25.37 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Mental Component Score | 0.08 score on a scale | Standard Deviation 10.328 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Mental Health Score | -2.06 score on a scale | Standard Deviation 20.066 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Change at Week 384: Bodily-Pain Score | -4.46 score on a scale | Standard Deviation 33.297 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Role-Physical Score | 53.57 score on a scale | Standard Deviation 42.029 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Bodily-Pain Score | 68.59 score on a scale | Standard Deviation 26.102 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline: Role-Emotional Score | 64.26 score on a scale | Standard Deviation 41.854 |
Secondary
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
Population: ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BG00012 240 mg BID | Change From Baseline in the Expanded Disability Status Scale (EDSS) at Week 384 | Baseline | 2.44 score on a scale | Standard Deviation 1.251 |
| BG00012 240 mg BID | Change From Baseline in the Expanded Disability Status Scale (EDSS) at Week 384 | Change at Week 384 | 0.28 score on a scale | Standard Deviation 1.16 |
| BG00012 240 mg TID | Change From Baseline in the Expanded Disability Status Scale (EDSS) at Week 384 | Baseline | 2.43 score on a scale | Standard Deviation 1.144 |
| BG00012 240 mg TID | Change From Baseline in the Expanded Disability Status Scale (EDSS) at Week 384 | Change at Week 384 | 0.26 score on a scale | Standard Deviation 1.213 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Change From Baseline in the Expanded Disability Status Scale (EDSS) at Week 384 | Baseline | 2.50 score on a scale | Standard Deviation 1.135 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Change From Baseline in the Expanded Disability Status Scale (EDSS) at Week 384 | Change at Week 384 | 0.37 score on a scale | Standard Deviation 1.328 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Change From Baseline in the Expanded Disability Status Scale (EDSS) at Week 384 | Baseline | 2.54 score on a scale | Standard Deviation 1.218 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Change From Baseline in the Expanded Disability Status Scale (EDSS) at Week 384 | Change at Week 384 | 0.53 score on a scale | Standard Deviation 1.278 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Change From Baseline in the Expanded Disability Status Scale (EDSS) at Week 384 | Baseline | 2.57 score on a scale | Standard Deviation 1.249 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Change From Baseline in the Expanded Disability Status Scale (EDSS) at Week 384 | Change at Week 384 | 0.39 score on a scale | Standard Deviation 1.217 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Change From Baseline in the Expanded Disability Status Scale (EDSS) at Week 384 | Baseline | 2.68 score on a scale | Standard Deviation 1.231 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Change From Baseline in the Expanded Disability Status Scale (EDSS) at Week 384 | Change at Week 384 | 0.49 score on a scale | Standard Deviation 1.319 |
Secondary
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
Population: ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BG00012 240 mg BID | Change From Baseline in Visual Function Test Scores at Week 384 | Change at Week 384: 2.5% Chart | -2.4 score on a scale | Standard Deviation 10.77 |
| BG00012 240 mg BID | Change From Baseline in Visual Function Test Scores at Week 384 | Baseline: 2.5% Chart | 32.4 score on a scale | Standard Deviation 12.17 |
| BG00012 240 mg BID | Change From Baseline in Visual Function Test Scores at Week 384 | Change at Week 384: 1.25% Chart | -5.8 score on a scale | Standard Deviation 13.39 |
| BG00012 240 mg BID | Change From Baseline in Visual Function Test Scores at Week 384 | Baseline: 1.25% Chart | 24.1 score on a scale | Standard Deviation 12.45 |
| BG00012 240 mg BID | Change From Baseline in Visual Function Test Scores at Week 384 | Baseline: 100% Chart | 54.7 score on a scale | Standard Deviation 7.95 |
| BG00012 240 mg BID | Change From Baseline in Visual Function Test Scores at Week 384 | Change at Week 384: 100% Chart | -0.4 score on a scale | Standard Deviation 6.76 |
| BG00012 240 mg TID | Change From Baseline in Visual Function Test Scores at Week 384 | Change at Week 384: 2.5% Chart | -3.3 score on a scale | Standard Deviation 10.43 |
| BG00012 240 mg TID | Change From Baseline in Visual Function Test Scores at Week 384 | Baseline: 100% Chart | 55.0 score on a scale | Standard Deviation 7.84 |
| BG00012 240 mg TID | Change From Baseline in Visual Function Test Scores at Week 384 | Baseline: 2.5% Chart | 32.6 score on a scale | Standard Deviation 11.76 |
| BG00012 240 mg TID | Change From Baseline in Visual Function Test Scores at Week 384 | Change at Week 384: 100% Chart | -1.9 score on a scale | Standard Deviation 6.81 |
| BG00012 240 mg TID | Change From Baseline in Visual Function Test Scores at Week 384 | Baseline: 1.25% Chart | 24.2 score on a scale | Standard Deviation 12.28 |
| BG00012 240 mg TID | Change From Baseline in Visual Function Test Scores at Week 384 | Change at Week 384: 1.25% Chart | -6.0 score on a scale | Standard Deviation 11.77 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Change From Baseline in Visual Function Test Scores at Week 384 | Baseline: 2.5% Chart | 32.4 score on a scale | Standard Deviation 11.42 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Change From Baseline in Visual Function Test Scores at Week 384 | Change at Week 384: 1.25% Chart | -4.1 score on a scale | Standard Deviation 13.04 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Change From Baseline in Visual Function Test Scores at Week 384 | Baseline: 1.25% Chart | 23.8 score on a scale | Standard Deviation 12.11 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Change From Baseline in Visual Function Test Scores at Week 384 | Change at Week 384: 100% Chart | -1.4 score on a scale | Standard Deviation 8.48 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Change From Baseline in Visual Function Test Scores at Week 384 | Baseline: 100% Chart | 55.1 score on a scale | Standard Deviation 7.26 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Change From Baseline in Visual Function Test Scores at Week 384 | Change at Week 384: 2.5% Chart | -1.5 score on a scale | Standard Deviation 11.77 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Change From Baseline in Visual Function Test Scores at Week 384 | Baseline: 100% Chart | 54.8 score on a scale | Standard Deviation 7.12 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Change From Baseline in Visual Function Test Scores at Week 384 | Change at Week 384: 2.5% Chart | -4.9 score on a scale | Standard Deviation 11.14 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Change From Baseline in Visual Function Test Scores at Week 384 | Change at Week 384: 1.25% Chart | -7.4 score on a scale | Standard Deviation 12.42 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Change From Baseline in Visual Function Test Scores at Week 384 | Baseline: 1.25% Chart | 23.7 score on a scale | Standard Deviation 12.96 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Change From Baseline in Visual Function Test Scores at Week 384 | Baseline: 2.5% Chart | 32.3 score on a scale | Standard Deviation 11.99 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Change From Baseline in Visual Function Test Scores at Week 384 | Change at Week 384: 100% Chart | -1.2 score on a scale | Standard Deviation 7.53 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Visual Function Test Scores at Week 384 | Baseline: 2.5% Chart | 31.8 score on a scale | Standard Deviation 12.36 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Visual Function Test Scores at Week 384 | Change at Week 384: 100% Chart | -1.6 score on a scale | Standard Deviation 8.05 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Visual Function Test Scores at Week 384 | Baseline: 100% Chart | 54.3 score on a scale | Standard Deviation 8.26 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Visual Function Test Scores at Week 384 | Change at Week 384: 2.5% Chart | -4.0 score on a scale | Standard Deviation 11.9 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Visual Function Test Scores at Week 384 | Change at Week 384: 1.25% Chart | -6.7 score on a scale | Standard Deviation 13.78 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Visual Function Test Scores at Week 384 | Baseline: 1.25% Chart | 23.4 score on a scale | Standard Deviation 11.76 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Visual Function Test Scores at Week 384 | Change at Week 384: 1.25% Chart | -5.0 score on a scale | Standard Deviation 12.74 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Visual Function Test Scores at Week 384 | Baseline: 100% Chart | 55.0 score on a scale | Standard Deviation 6.73 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Visual Function Test Scores at Week 384 | Change at Week 384: 100% Chart | -0.7 score on a scale | Standard Deviation 5.17 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Visual Function Test Scores at Week 384 | Baseline: 2.5% Chart | 31.7 score on a scale | Standard Deviation 12.41 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Visual Function Test Scores at Week 384 | Change at Week 384: 2.5% Chart | -2.1 score on a scale | Standard Deviation 9.86 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Change From Baseline in Visual Function Test Scores at Week 384 | Baseline: 1.25% Chart | 22.2 score on a scale | Standard Deviation 13.25 |
Secondary
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
Population: MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BG00012 240 mg BID | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 0.4 lesions | Standard Deviation 1.87 |
| BG00012 240 mg BID | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 0.4 lesions | Standard Deviation 1.77 |
| BG00012 240 mg BID | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 0.3 lesions | Standard Deviation 1.66 |
| BG00012 240 mg BID | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 0.4 lesions | Standard Deviation 2.02 |
| BG00012 240 mg BID | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 0.5 lesions | Standard Deviation 3.14 |
| BG00012 240 mg BID | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 0.2 lesions | Standard Deviation 0.74 |
| BG00012 240 mg TID | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 0.4 lesions | Standard Deviation 1.28 |
| BG00012 240 mg TID | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 0.5 lesions | Standard Deviation 1.85 |
| BG00012 240 mg TID | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 0.5 lesions | Standard Deviation 1.81 |
| BG00012 240 mg TID | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 0.4 lesions | Standard Deviation 1.29 |
| BG00012 240 mg TID | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 0.4 lesions | Standard Deviation 1.3 |
| BG00012 240 mg TID | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 0.5 lesions | Standard Deviation 2.29 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 0.1 lesions | Standard Deviation 0.4 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 0.2 lesions | Standard Deviation 0.5 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 0.5 lesions | Standard Deviation 1.72 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 0.2 lesions | Standard Deviation 0.44 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 0.2 lesions | Standard Deviation 0.66 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 0.1 lesions | Standard Deviation 0.38 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 0.3 lesions | Standard Deviation 0.96 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 0.2 lesions | Standard Deviation 0.82 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 0.1 lesions | Standard Deviation 0.29 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 0.7 lesions | Standard Deviation 2.76 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 0.2 lesions | Standard Deviation 0.51 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 0.3 lesions | Standard Deviation 1.14 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 0.5 lesions | Standard Deviation 1.19 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 0.2 lesions | Standard Deviation 0.58 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 0.6 lesions | Standard Deviation 1.33 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 0.5 lesions | Standard Deviation 2.48 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 0.2 lesions | Standard Deviation 0.6 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 0.0 lesions | Standard Deviation 0 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 0.6 lesions | Standard Deviation 2.01 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 0.3 lesions | Standard Deviation 1.59 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 0.3 lesions | Standard Deviation 0.75 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 0.3 lesions | Standard Deviation 0.77 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 0.3 lesions | Standard Deviation 0.73 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 0.4 lesions | Standard Deviation 1.14 |
Secondary
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
Population: MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BG00012 240 mg BID | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 1.6 lesions | Standard Deviation 4.07 |
| BG00012 240 mg BID | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 3.4 lesions | Standard Deviation 8.35 |
| BG00012 240 mg BID | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 4.2 lesions | Standard Deviation 9.81 |
| BG00012 240 mg BID | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 5.8 lesions | Standard Deviation 14.04 |
| BG00012 240 mg BID | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 7.4 lesions | Standard Deviation 17.09 |
| BG00012 240 mg BID | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 8.2 lesions | Standard Deviation 18.53 |
| BG00012 240 mg TID | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 4.1 lesions | Standard Deviation 10.01 |
| BG00012 240 mg TID | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 7.5 lesions | Standard Deviation 15.14 |
| BG00012 240 mg TID | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 12.4 lesions | Standard Deviation 28.23 |
| BG00012 240 mg TID | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 2.2 lesions | Standard Deviation 6.15 |
| BG00012 240 mg TID | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 5.2 lesions | Standard Deviation 10.01 |
| BG00012 240 mg TID | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 9.5 lesions | Standard Deviation 20.33 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 7.5 lesions | Standard Deviation 13.89 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 8.2 lesions | Standard Deviation 14.87 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 5.6 lesions | Standard Deviation 10.09 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 4.0 lesions | Standard Deviation 7.27 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 2.7 lesions | Standard Deviation 4.96 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 3.8 lesions | Standard Deviation 7.24 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 5.6 lesions | Standard Deviation 14.19 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 2.9 lesions | Standard Deviation 6.78 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 4.3 lesions | Standard Deviation 10.12 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 10.4 lesions | Standard Deviation 22.05 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 7.7 lesions | Standard Deviation 17.89 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 2.4 lesions | Standard Deviation 5.45 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 3.4 lesions | Standard Deviation 6.57 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 6.8 lesions | Standard Deviation 11.74 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 4.9 lesions | Standard Deviation 8.51 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 5.7 lesions | Standard Deviation 9.45 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 5.5 lesions | Standard Deviation 9.94 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 8.9 lesions | Standard Deviation 15.04 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 5.6 lesions | Standard Deviation 13.35 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 5.2 lesions | Standard Deviation 9.68 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 7.5 lesions | Standard Deviation 16.76 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 6.0 lesions | Standard Deviation 8.9 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 3.4 lesions | Standard Deviation 5.13 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 2.1 lesions | Standard Deviation 3.83 |
Secondary
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
Population: MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BG00012 240 mg BID | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 0.8 lesions | Standard Deviation 2.13 |
| BG00012 240 mg BID | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 2.7 lesions | Standard Deviation 5.72 |
| BG00012 240 mg BID | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 1.7 lesions | Standard Deviation 3.63 |
| BG00012 240 mg BID | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 2.9 lesions | Standard Deviation 7.03 |
| BG00012 240 mg BID | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 2.0 lesions | Standard Deviation 4.61 |
| BG00012 240 mg BID | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 3.4 lesions | Standard Deviation 8.25 |
| BG00012 240 mg TID | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 5.9 lesions | Standard Deviation 12.02 |
| BG00012 240 mg TID | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 3.4 lesions | Standard Deviation 6.79 |
| BG00012 240 mg TID | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 1.0 lesions | Standard Deviation 2.37 |
| BG00012 240 mg TID | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 1.9 lesions | Standard Deviation 3.91 |
| BG00012 240 mg TID | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 4.8 lesions | Standard Deviation 9.39 |
| BG00012 240 mg TID | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 2.8 lesions | Standard Deviation 5.19 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 4.5 lesions | Standard Deviation 7.38 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 2.0 lesions | Standard Deviation 3.69 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 1.8 lesions | Standard Deviation 3.81 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 4.0 lesions | Standard Deviation 7.52 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 2.9 lesions | Standard Deviation 5.12 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 1.8 lesions | Standard Deviation 3.33 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 2.6 lesions | Standard Deviation 7.02 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 3.6 lesions | Standard Deviation 4.51 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 1.7 lesions | Standard Deviation 3.71 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 2.1 lesions | Standard Deviation 5 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 3.8 lesions | Standard Deviation 10.71 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 4.9 lesions | Standard Deviation 13.3 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 1.0 lesions | Standard Deviation 1.1 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 3.3 lesions | Standard Deviation 6.74 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 3.0 lesions | Standard Deviation 5.85 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 4.0 lesions | Standard Deviation 8.06 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 2.0 lesions | Standard Deviation 4.22 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 3.1 lesions | Standard Deviation 6.2 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 5.6 lesions | Standard Deviation 6.81 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 2.9 lesions | Standard Deviation 5.19 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 3.0 lesions | Standard Deviation 7.14 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 1.9 lesions | Standard Deviation 3.44 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 4.2 lesions | Standard Deviation 10.2 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 1.3 lesions | Standard Deviation 2.64 |
Secondary
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
Population: ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. Data for this outcome measure (OM) was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BG00012 240 mg BID | Percentage of Participants Who Had Relapses | 40 percentage of participants |
| BG00012 240 mg TID | Percentage of Participants Who Had Relapses | 41 percentage of participants |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Percentage of Participants Who Had Relapses | 34 percentage of participants |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Percentage of Participants Who Had Relapses | 36 percentage of participants |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Percentage of Participants Who Had Relapses | 31 percentage of participants |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Percentage of Participants Who Had Relapses | 31 percentage of participants |
Secondary
Percent Change From Baseline in Brain Atrophy
Brain atrophy was measured using magnetic resonance imaging (MRI) technique.
Time frame: Baseline up to Week 288
Population: MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BG00012 240 mg BID | Percent Change From Baseline in Brain Atrophy | Change at Week 48 | -1.206 percent change | Standard Deviation 1.1006 |
| BG00012 240 mg BID | Percent Change From Baseline in Brain Atrophy | Change at Week 96 | -1.372 percent change | Standard Deviation 1.1382 |
| BG00012 240 mg BID | Percent Change From Baseline in Brain Atrophy | Change at Week 144 | -1.708 percent change | Standard Deviation 1.4109 |
| BG00012 240 mg BID | Percent Change From Baseline in Brain Atrophy | Change at Week 192 | -2.138 percent change | Standard Deviation 1.6831 |
| BG00012 240 mg BID | Percent Change From Baseline in Brain Atrophy | Change at Week 240 | -2.313 percent change | Standard Deviation 1.6309 |
| BG00012 240 mg BID | Percent Change From Baseline in Brain Atrophy | Change at Week 288 | -2.216 percent change | Standard Deviation 1.5744 |
| BG00012 240 mg TID | Percent Change From Baseline in Brain Atrophy | Change at Week 96 | -1.500 percent change | Standard Deviation 1.0893 |
| BG00012 240 mg TID | Percent Change From Baseline in Brain Atrophy | Change at Week 192 | -2.117 percent change | Standard Deviation 1.4 |
| BG00012 240 mg TID | Percent Change From Baseline in Brain Atrophy | Change at Week 288 | -2.271 percent change | Standard Deviation 1.2193 |
| BG00012 240 mg TID | Percent Change From Baseline in Brain Atrophy | Change at Week 48 | -1.263 percent change | Standard Deviation 1.0848 |
| BG00012 240 mg TID | Percent Change From Baseline in Brain Atrophy | Change at Week 144 | -1.876 percent change | Standard Deviation 1.2604 |
| BG00012 240 mg TID | Percent Change From Baseline in Brain Atrophy | Change at Week 240 | -2.253 percent change | Standard Deviation 1.3721 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Percent Change From Baseline in Brain Atrophy | Change at Week 288 | -2.470 percent change | Standard Deviation 1.6757 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Percent Change From Baseline in Brain Atrophy | Change at Week 240 | -2.271 percent change | Standard Deviation 1.4817 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Percent Change From Baseline in Brain Atrophy | Change at Week 192 | -2.230 percent change | Standard Deviation 1.7755 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Percent Change From Baseline in Brain Atrophy | Change at Week 144 | -2.139 percent change | Standard Deviation 1.5884 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Percent Change From Baseline in Brain Atrophy | Change at Week 48 | -1.487 percent change | Standard Deviation 1.3086 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Percent Change From Baseline in Brain Atrophy | Change at Week 96 | -1.589 percent change | Standard Deviation 1.363 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Percent Change From Baseline in Brain Atrophy | Change at Week 192 | -2.476 percent change | Standard Deviation 1.7062 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Percent Change From Baseline in Brain Atrophy | Change at Week 96 | -1.775 percent change | Standard Deviation 1.7191 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Percent Change From Baseline in Brain Atrophy | Change at Week 144 | -2.353 percent change | Standard Deviation 1.7897 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Percent Change From Baseline in Brain Atrophy | Change at Week 288 | -2.849 percent change | Standard Deviation 1.9648 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Percent Change From Baseline in Brain Atrophy | Change at Week 240 | -2.593 percent change | Standard Deviation 1.9043 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Percent Change From Baseline in Brain Atrophy | Change at Week 48 | -1.320 percent change | Standard Deviation 1.4021 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Percent Change From Baseline in Brain Atrophy | Change at Week 48 | -1.496 percent change | Standard Deviation 1.1316 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Percent Change From Baseline in Brain Atrophy | Change at Week 240 | -2.249 percent change | Standard Deviation 1.2985 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Percent Change From Baseline in Brain Atrophy | Change at Week 96 | -1.883 percent change | Standard Deviation 1.2383 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Percent Change From Baseline in Brain Atrophy | Change at Week 144 | -2.386 percent change | Standard Deviation 1.3168 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Percent Change From Baseline in Brain Atrophy | Change at Week 192 | -2.645 percent change | Standard Deviation 1.2284 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Percent Change From Baseline in Brain Atrophy | Change at Week 288 | -2.657 percent change | Standard Deviation 1.7051 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Percent Change From Baseline in Brain Atrophy | Change at Week 192 | -2.417 percent change | Standard Deviation 2.0486 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Percent Change From Baseline in Brain Atrophy | Change at Week 144 | -2.252 percent change | Standard Deviation 2.2124 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Percent Change From Baseline in Brain Atrophy | Change at Week 240 | -2.790 percent change | Standard Deviation 2.2188 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Percent Change From Baseline in Brain Atrophy | Change at Week 288 | -2.496 percent change | Standard Deviation 1.3699 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Percent Change From Baseline in Brain Atrophy | Change at Week 96 | -1.810 percent change | Standard Deviation 1.4556 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Percent Change From Baseline in Brain Atrophy | Change at Week 48 | -1.414 percent change | Standard Deviation 1.1882 |
Secondary
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
Population: MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BG00012 240 mg BID | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 240 | -0.002 percent change | Standard Deviation 15.619 |
| BG00012 240 mg BID | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 48 | -0.325 percent change | Standard Deviation 5.4932 |
| BG00012 240 mg BID | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 96 | -0.427 percent change | Standard Deviation 6.6493 |
| BG00012 240 mg BID | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 192 | 1.038 percent change | Standard Deviation 10.868 |
| BG00012 240 mg BID | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 288 | 0.002 percent change | Standard Deviation 4.0206 |
| BG00012 240 mg BID | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 144 | -0.042 percent change | Standard Deviation 9.2548 |
| BG00012 240 mg TID | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 48 | -0.383 percent change | Standard Deviation 4.8621 |
| BG00012 240 mg TID | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 240 | 1.647 percent change | Standard Deviation 8.3094 |
| BG00012 240 mg TID | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 288 | -0.391 percent change | Standard Deviation 4.6415 |
| BG00012 240 mg TID | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 96 | -0.532 percent change | Standard Deviation 4.988 |
| BG00012 240 mg TID | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 144 | 0.509 percent change | Standard Deviation 7.2692 |
| BG00012 240 mg TID | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 192 | 0.955 percent change | Standard Deviation 8.6105 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 48 | 1.034 percent change | Standard Deviation 7.3548 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 192 | 3.012 percent change | Standard Deviation 9.3831 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 240 | 3.213 percent change | Standard Deviation 9.6621 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 144 | 1.525 percent change | Standard Deviation 8.6421 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 96 | 1.630 percent change | Standard Deviation 7.6584 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 288 | -0.666 percent change | Standard Deviation 2.0741 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 96 | -0.947 percent change | Standard Deviation 7.0771 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 48 | -0.567 percent change | Standard Deviation 4.4766 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 144 | 1.411 percent change | Standard Deviation 12.2825 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 240 | 4.108 percent change | Standard Deviation 13.8103 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 192 | 3.103 percent change | Standard Deviation 13.0046 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 288 | -0.622 percent change | Standard Deviation 2.2922 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 144 | -4.460 percent change | Standard Deviation 10.3887 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 48 | -0.081 percent change | Standard Deviation 13.6416 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 96 | -4.269 percent change | Standard Deviation 12.6065 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 192 | 1.384 percent change | Standard Deviation 15.7611 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 240 | 2.959 percent change | Standard Deviation 16.8386 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 288 | -0.466 percent change | Standard Deviation 0.941 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 288 | -1.114 percent change | Standard Deviation 2.4539 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 240 | 0.673 percent change | Standard Deviation 25.9962 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 96 | 0.215 percent change | Standard Deviation 1.427 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 48 | -0.334 percent change | Standard Deviation 1.5103 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 192 | 3.841 percent change | Standard Deviation 10.86 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Change at Week 144 | 3.119 percent change | Standard Deviation 8.1676 |
Secondary
Volume of 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
Population: MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BG00012 240 mg BID | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline | 31.7 millimeter cube (mm^3) | Standard Deviation 179.28 |
| BG00012 240 mg BID | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 39.1 millimeter cube (mm^3) | Standard Deviation 217.89 |
| BG00012 240 mg BID | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 59.6 millimeter cube (mm^3) | Standard Deviation 526.51 |
| BG00012 240 mg BID | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 18.2 millimeter cube (mm^3) | Standard Deviation 93.28 |
| BG00012 240 mg BID | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 49.1 millimeter cube (mm^3) | Standard Deviation 245.14 |
| BG00012 240 mg BID | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 96.8 millimeter cube (mm^3) | Standard Deviation 650.06 |
| BG00012 240 mg BID | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 44.1 millimeter cube (mm^3) | Standard Deviation 291.14 |
| BG00012 240 mg TID | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 70.0 millimeter cube (mm^3) | Standard Deviation 366.63 |
| BG00012 240 mg TID | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 47.0 millimeter cube (mm^3) | Standard Deviation 169.68 |
| BG00012 240 mg TID | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 56.1 millimeter cube (mm^3) | Standard Deviation 271.29 |
| BG00012 240 mg TID | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 54.5 millimeter cube (mm^3) | Standard Deviation 251.31 |
| BG00012 240 mg TID | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline | 48.6 millimeter cube (mm^3) | Standard Deviation 205.43 |
| BG00012 240 mg TID | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 53.1 millimeter cube (mm^3) | Standard Deviation 250.87 |
| BG00012 240 mg TID | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 69.3 millimeter cube (mm^3) | Standard Deviation 374.67 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 27.7 millimeter cube (mm^3) | Standard Deviation 204.8 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 18.8 millimeter cube (mm^3) | Standard Deviation 91.47 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline | 96.0 millimeter cube (mm^3) | Standard Deviation 260.79 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 45.8 millimeter cube (mm^3) | Standard Deviation 156.88 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 21.7 millimeter cube (mm^3) | Standard Deviation 77.87 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 18.8 millimeter cube (mm^3) | Standard Deviation 66.15 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 7.9 millimeter cube (mm^3) | Standard Deviation 30.09 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 3.8 millimeter cube (mm^3) | Standard Deviation 25.03 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline | 142.5 millimeter cube (mm^3) | Standard Deviation 459.76 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 25.3 millimeter cube (mm^3) | Standard Deviation 108.19 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 13.3 millimeter cube (mm^3) | Standard Deviation 67.01 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 19.9 millimeter cube (mm^3) | Standard Deviation 79.19 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 14.1 millimeter cube (mm^3) | Standard Deviation 45.22 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 230.2 millimeter cube (mm^3) | Standard Deviation 1092.11 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 64.3 millimeter cube (mm^3) | Standard Deviation 183.16 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 42.5 millimeter cube (mm^3) | Standard Deviation 123.67 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 0.0 millimeter cube (mm^3) | Standard Deviation 0 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline | 37.1 millimeter cube (mm^3) | Standard Deviation 138.82 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 17.5 millimeter cube (mm^3) | Standard Deviation 46.19 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 42.6 millimeter cube (mm^3) | Standard Deviation 142.55 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 12.0 millimeter cube (mm^3) | Standard Deviation 40.56 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 34.1 millimeter cube (mm^3) | Standard Deviation 102.87 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 55.1 millimeter cube (mm^3) | Standard Deviation 169.16 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 22.3 millimeter cube (mm^3) | Standard Deviation 60.83 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 42.7 millimeter cube (mm^3) | Standard Deviation 148.11 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 17.1 millimeter cube (mm^3) | Standard Deviation 48.41 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline | 41.7 millimeter cube (mm^3) | Standard Deviation 116.55 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 92.9 millimeter cube (mm^3) | Standard Deviation 397.69 |
Secondary
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
Population: MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BG00012 240 mg BID | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 10331.3 mm^3 | Standard Deviation 11359.81 |
| BG00012 240 mg BID | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 9951.9 mm^3 | Standard Deviation 10750.15 |
| BG00012 240 mg BID | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 10611.2 mm^3 | Standard Deviation 11633.95 |
| BG00012 240 mg BID | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline | 10231.9 mm^3 | Standard Deviation 11214.17 |
| BG00012 240 mg BID | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 9611.8 mm^3 | Standard Deviation 9447.18 |
| BG00012 240 mg BID | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 9837.7 mm^3 | Standard Deviation 10845.04 |
| BG00012 240 mg BID | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 9930.1 mm^3 | Standard Deviation 10686.26 |
| BG00012 240 mg TID | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 11087.5 mm^3 | Standard Deviation 12464.9 |
| BG00012 240 mg TID | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline | 10408.3 mm^3 | Standard Deviation 12166.8 |
| BG00012 240 mg TID | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 9849.6 mm^3 | Standard Deviation 10986.36 |
| BG00012 240 mg TID | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 10434.0 mm^3 | Standard Deviation 12201.38 |
| BG00012 240 mg TID | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 10280.7 mm^3 | Standard Deviation 11324.58 |
| BG00012 240 mg TID | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 10760.0 mm^3 | Standard Deviation 11987.16 |
| BG00012 240 mg TID | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 9800.8 mm^3 | Standard Deviation 11279.84 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 9711.1 mm^3 | Standard Deviation 8709.46 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 8819.8 mm^3 | Standard Deviation 8866.9 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 8829.4 mm^3 | Standard Deviation 7482.93 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 9077.6 mm^3 | Standard Deviation 7794.52 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 8645.2 mm^3 | Standard Deviation 7787.6 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 8992.1 mm^3 | Standard Deviation 7952.13 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline | 8883.7 mm^3 | Standard Deviation 8570.1 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline | 10806.3 mm^3 | Standard Deviation 12060.05 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 10576.3 mm^3 | Standard Deviation 12029.26 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 10591.4 mm^3 | Standard Deviation 11613.26 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 10114.5 mm^3 | Standard Deviation 10121.61 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 9985.7 mm^3 | Standard Deviation 10715.73 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 10537.6 mm^3 | Standard Deviation 10684.47 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 9792.3 mm^3 | Standard Deviation 9842.28 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 11160.7 mm^3 | Standard Deviation 9565.55 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline | 12628.9 mm^3 | Standard Deviation 11258.69 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 11318.1 mm^3 | Standard Deviation 9873.73 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 10188.5 mm^3 | Standard Deviation 8064.09 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 11586.3 mm^3 | Standard Deviation 9728.19 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 10421.9 mm^3 | Standard Deviation 8773.41 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 11009.9 mm^3 | Standard Deviation 9551.94 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 12254.4 mm^3 | Standard Deviation 13732.1 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 11671.5 mm^3 | Standard Deviation 13124.47 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline | 13044.4 mm^3 | Standard Deviation 14608.5 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 10404.8 mm^3 | Standard Deviation 12245.75 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 12949.7 mm^3 | Standard Deviation 14036.15 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 13974.1 mm^3 | Standard Deviation 15432.1 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 12979.0 mm^3 | Standard Deviation 14415.86 |
Secondary
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
Population: MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BG00012 240 mg BID | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline | 3640.1 mm^3 | Standard Deviation 5598.31 |
| BG00012 240 mg BID | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 3834.9 mm^3 | Standard Deviation 4942.19 |
| BG00012 240 mg BID | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 3829.5 mm^3 | Standard Deviation 5824.26 |
| BG00012 240 mg BID | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 3603.3 mm^3 | Standard Deviation 4394.6 |
| BG00012 240 mg BID | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 3841.2 mm^3 | Standard Deviation 5682.74 |
| BG00012 240 mg BID | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 4038.6 mm^3 | Standard Deviation 5145.85 |
| BG00012 240 mg BID | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 3767.4 mm^3 | Standard Deviation 4969.23 |
| BG00012 240 mg TID | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 3715.5 mm^3 | Standard Deviation 5112.21 |
| BG00012 240 mg TID | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 4074.0 mm^3 | Standard Deviation 5413.85 |
| BG00012 240 mg TID | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 3853.7 mm^3 | Standard Deviation 5428.66 |
| BG00012 240 mg TID | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 4177.4 mm^3 | Standard Deviation 5301.68 |
| BG00012 240 mg TID | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline | 3447.3 mm^3 | Standard Deviation 4900.96 |
| BG00012 240 mg TID | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 3973.1 mm^3 | Standard Deviation 5202.05 |
| BG00012 240 mg TID | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 4238.2 mm^3 | Standard Deviation 5248.84 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 2921.0 mm^3 | Standard Deviation 3327.93 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 2891.9 mm^3 | Standard Deviation 3034 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline | 2754.2 mm^3 | Standard Deviation 3552.3 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 3385.4 mm^3 | Standard Deviation 3575.44 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 3406.4 mm^3 | Standard Deviation 3936.73 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 3145.6 mm^3 | Standard Deviation 3366.27 |
| BG00012 240 mg BID (Prior BG00012 Matched Placebo) | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 3350.6 mm^3 | Standard Deviation 4140.34 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 4006.9 mm^3 | Standard Deviation 5062.08 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline | 3623.1 mm^3 | Standard Deviation 5549.13 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 3936.0 mm^3 | Standard Deviation 5271.89 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 3849.4 mm^3 | Standard Deviation 5167.13 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 4330.0 mm^3 | Standard Deviation 5136.67 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 3823.9 mm^3 | Standard Deviation 4274.82 |
| BG00012 240 mg TID (Prior BG00012 Matched Placebo) | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 4187.5 mm^3 | Standard Deviation 4835.43 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 3510.4 mm^3 | Standard Deviation 4672.8 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 3271.0 mm^3 | Standard Deviation 4157.24 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 3264.9 mm^3 | Standard Deviation 3639.91 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline | 3204.3 mm^3 | Standard Deviation 4221.55 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 3503.4 mm^3 | Standard Deviation 3933.75 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 3499.2 mm^3 | Standard Deviation 4198.5 |
| BG00012 240 mg BID (Prior Glatiramer Acetate [GA]) | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 3592.0 mm^3 | Standard Deviation 4069.39 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 288 | 2959.1 mm^3 | Standard Deviation 3918.62 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 192 | 4089.3 mm^3 | Standard Deviation 4996.13 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 96 | 3949.7 mm^3 | Standard Deviation 5018.63 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 48 | 3743.3 mm^3 | Standard Deviation 5374.24 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 240 | 4057.7 mm^3 | Standard Deviation 5223.62 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline | 3572.6 mm^3 | Standard Deviation 4915.24 |
| BG00012 240 mg TID (Prior Glatiramer Acetate [GA]) | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Week 144 | 4126.1 mm^3 | Standard Deviation 5695.44 |