Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis
Conditions
Keywords
BG00012, MS, RRMS
Brief summary
The primary objective of the study is to evaluate the safety and tolerability of BG00012 (dimethyl fumarate) administered in combination with interferon b (IFNß) or glatiramer acetate (GA) in participants with relapsing-remitting multiple sclerosis (RRMS).
Interventions
DRUGdimethyl fumarate
Days 1-7: 120 mg three times a day (TID) for a total daily dose of 360 mg. Day 8 to Week 24: 240 mg TID for a total daily dose of 720 mg. Drug supplied as a capsule taken orally.
Sponsors
Biogen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Must have a confirmed diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to McDonald criteria #1-4 (Polman et al, 2005 \[Appendix I\]), and have a prior brain magnetic resonance imaging (MRI) demonstrating lesion (s) consistent with multiple sclerosis (MS) from any point in time. * Must have an Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive. * Must be taking the same dose of a prescribed IFNβ (either Avonex, Betaseron, Rebif) or GA for at least 12 months consecutively at the time of enrollment and remain on this treatment for the duration of the study. Participants receiving Rebif must be prescribed 44 μg by subcutaneous injection three times per week. Key
Exclusion criteria
* Primary progressive, secondary progressive, or progressive relapsing MS (as defined by Polman et al. 2005). * Other chronic disease of the immune system, malignancies, acute urologic, or pulmonary disease. * Pregnant or nursing women. * Participation within 6 months prior to study enrollment in any other drug, biologic, or device study. NOTE: Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | collected from the start of BG00012 administration through to Week 26 +/- 5 days | Percentage of participants with post-baseline values for selected urinalysis parameters requiring further evaluation. For urine microscopy, results were categorized for male and female participants. For males, normal/negative was considered 0 to 3 red blood cells/high-power field (rbc/hpf), and positive was categorized in the following stages: 4 to 10, 11 to 20, 21 to 149, and ≥ 150 rbc/hpf. For females, normal/negative was considered 0 to 8 rbc/hpf, and positive was categorized in the following stages: 9 to 20, 21 to 30, 31 to 149, and ≥ 150 rbc/hpf. |
| Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period) | AEs were collected from enrollment until the final study visit (Week 26 +/-5 days). | An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the study drug. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose: resulted in death; in the view of the Investigator, placed the participant at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; was any other medically important event that, in the opinion of the Investigator, jeopardized the participant or required intervention to prevent one of the other outcomes above. TEAE was defined as having an onset date that was on or after the start of study treatment (BG00012), or that worsened after the start of study treatment. |
| Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy | collected from the start of BG00012 administration through to Week 26 +/- 5 days | Percentage of participants with potentially clinically significant hematology laboratory abnormalities. |
| Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | collected from the start of BG00012 administration through to Week 26 +/- 5 days | Percentage of participants with post-baseline liver enzyme values above the upper limit of normal (ULN). Liver enzymes included alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT), and bilirubin. Elevated ALT/AST (ALT/AST ≥ 3\*ULN) concurrent with elevated total bilirubin was also evaluated. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of New or Newly Enlarging T2 Lesions | Week -8 to Week 24 | The number of new T2 lesions divided by the number of months since the reference visit during the Monotherapy Period and the Add-On Therapy Period. |
| Summary of Adverse Events (AEs) Occurring Before BG00012 Dosing (Monotherapy Period) | from time of enrollment until day before first administration of BG00012 (Week -8 to Week 0) | Percentage of participants with AEs, serious AEs (SAEs), and discontinuations due to AEs. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the study drug. An SAE was any untoward medical occurrence that, at any dose: resulted in death; in the view of the Investigator, placed the participant at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; was any other medically important event that, in the opinion of the Investigator, jeopardized the participant or required intervention to prevent one of the other outcomes above. AEs were categorized as mild, moderate, or severe. All AEs occurring from enrollment to the day before BG00012 dosing are included. |
| Average Number of Gadolinium (Gd)-Enhancing Lesions: Week -8, -4, 0 Average Versus Week 16, 20, 24 Average | Week -8 through Week 24 | The average is calculated as (total number of lesions in non-missing scans / number of non-missing magnetic resonance imaging \[MRI\] scans). |
| Average Number of New Gd-Enhancing Lesions: Weeks -4, 0 Average Versus Weeks 20, 24 Average | Week -4 through Week 24 | The average is calculated as (total number of lesions in non-missing scans / number of non-missing MRI scans). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months). | 57 |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months). | 47 |
| Total | 104 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| 2-Month Monotherapy Period | Other | 1 | 0 | 0 | 0 |
| 2-Month Monotherapy Period | Physician Decision | 0 | 1 | 0 | 0 |
| 2-Month Monotherapy Period | Withdrawal by Subject | 1 | 1 | 0 | 0 |
| 6-month Add-on Therapy Period | Adverse Event | 0 | 0 | 7 | 6 |
| 6-month Add-on Therapy Period | Disease Activity | 0 | 0 | 1 | 2 |
| 6-month Add-on Therapy Period | Lost to Follow-up | 0 | 0 | 2 | 0 |
| 6-month Add-on Therapy Period | Other | 0 | 0 | 1 | 2 |
| 6-month Add-on Therapy Period | Physician Decision | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | Total |
|---|---|---|---|
| Age, Continuous | 39.5 years STANDARD_DEVIATION 7.58 | 40.7 years STANDARD_DEVIATION 8.44 | 40.1 years STANDARD_DEVIATION 7.96 |
| Age, Customized 18 to 19 years | 1 participants | 0 participants | 1 participants |
| Age, Customized 20 to 29 years | 5 participants | 3 participants | 8 participants |
| Age, Customized 30 to 39 years | 18 participants | 22 participants | 40 participants |
| Age, Customized 40 to 49 years | 27 participants | 15 participants | 42 participants |
| Age, Customized 50 to 55 years | 6 participants | 7 participants | 13 participants |
| Sex: Female, Male Female | 40 Participants | 29 Participants | 69 Participants |
| Sex: Female, Male Male | 17 Participants | 18 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 59 | 7 / 49 | 53 / 57 | 45 / 47 |
| serious Total, serious adverse events | 0 / 59 | 0 / 49 | 2 / 57 | 1 / 47 |
Outcome results
Primary
Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy
Percentage of participants with post-baseline liver enzyme values above the upper limit of normal (ULN). Liver enzymes included alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT), and bilirubin. Elevated ALT/AST (ALT/AST ≥ 3\*ULN) concurrent with elevated total bilirubin was also evaluated.
Time frame: collected from the start of BG00012 administration through to Week 26 +/- 5 days
Population: Participants in the safety population with at least one post-baseline value. Safety Population for the Combination Therapy Period was defined as any participant who took at least 1 capsule of BG00012 concurrently with the background therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Monotherapy Period: IFNß | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | ALT ≤ 1*ULN | 47 percentage of participants |
| Monotherapy Period: IFNß | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | ALT > 1*ULN | 53 percentage of participants |
| Monotherapy Period: IFNß | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | ALT ≥ 3*ULN | 5 percentage of participants |
| Monotherapy Period: IFNß | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | ALT > 10*ULN | 0 percentage of participants |
| Monotherapy Period: IFNß | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | ALT > 20*ULN | 0 percentage of participants |
| Monotherapy Period: IFNß | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | AST ≤ 1*ULN | 68 percentage of participants |
| Monotherapy Period: IFNß | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | AST > 1*ULN | 32 percentage of participants |
| Monotherapy Period: IFNß | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | AST ≥ 3*ULN | 2 percentage of participants |
| Monotherapy Period: IFNß | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | AST > 5*ULN | 0 percentage of participants |
| Monotherapy Period: IFNß | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | AST > 10*ULN | 0 percentage of participants |
| Monotherapy Period: IFNß | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | AST > 20*ULN | 0 percentage of participants |
| Monotherapy Period: IFNß | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | GGT ≤ 1*ULN | 72 percentage of participants |
| Monotherapy Period: IFNß | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | GGT > 1*ULN | 28 percentage of participants |
| Monotherapy Period: IFNß | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | GGT ≥ 3*ULN | 4 percentage of participants |
| Monotherapy Period: IFNß | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | GGT > 5*ULN | 2 percentage of participants |
| Monotherapy Period: IFNß | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | ALT/AST ≥ 3*ULN + Total Bilirubin > 2*ULN | 0 percentage of participants |
| Monotherapy Period: IFNß | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | ALT > 5*ULN | 2 percentage of participants |
| Monotherapy Period: IFNß | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | GGT > 10*ULN | 0 percentage of participants |
| Monotherapy Period: IFNß | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | GGT > 20*ULN | 0 percentage of participants |
| Monotherapy Period: IFNß | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | Total Bilirubin ≤ 1*ULN | 98 percentage of participants |
| Monotherapy Period: IFNß | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | Total Bilirubin > 1*ULN | 2 percentage of participants |
| Monotherapy Period: IFNß | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | Total Bilirubin > 1.5*ULN | 0 percentage of participants |
| Monotherapy Period: IFNß | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | Total Bilirubin > 2*ULN | 0 percentage of participants |
| Monotherapy Period: IFNß | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | ALT/AST ≥ 3*ULN + Total Bilirubin > 1.5*ULN | 0 percentage of participants |
| Monotherapy Period: GA | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | GGT > 1*ULN | 15 percentage of participants |
| Monotherapy Period: GA | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | ALT ≤ 1*ULN | 47 percentage of participants |
| Monotherapy Period: GA | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | Total Bilirubin > 1*ULN | 6 percentage of participants |
| Monotherapy Period: GA | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | ALT > 1*ULN | 53 percentage of participants |
| Monotherapy Period: GA | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | GGT ≥ 3*ULN | 0 percentage of participants |
| Monotherapy Period: GA | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | ALT > 5*ULN | 0 percentage of participants |
| Monotherapy Period: GA | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | GGT > 20*ULN | 0 percentage of participants |
| Monotherapy Period: GA | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | ALT > 10*ULN | 0 percentage of participants |
| Monotherapy Period: GA | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | ALT/AST ≥ 3*ULN + Total Bilirubin > 1.5*ULN | 0 percentage of participants |
| Monotherapy Period: GA | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | ALT > 20*ULN | 0 percentage of participants |
| Monotherapy Period: GA | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | Total Bilirubin > 2*ULN | 2 percentage of participants |
| Monotherapy Period: GA | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | ALT/AST ≥ 3*ULN + Total Bilirubin > 2*ULN | 0 percentage of participants |
| Monotherapy Period: GA | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | AST > 1*ULN | 36 percentage of participants |
| Monotherapy Period: GA | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | ALT ≥ 3*ULN | 2 percentage of participants |
| Monotherapy Period: GA | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | AST ≥ 3*ULN | 0 percentage of participants |
| Monotherapy Period: GA | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | Total Bilirubin ≤ 1*ULN | 94 percentage of participants |
| Monotherapy Period: GA | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | AST > 5*ULN | 0 percentage of participants |
| Monotherapy Period: GA | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | AST ≤ 1*ULN | 64 percentage of participants |
| Monotherapy Period: GA | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | AST > 10*ULN | 0 percentage of participants |
| Monotherapy Period: GA | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | GGT > 5*ULN | 0 percentage of participants |
| Monotherapy Period: GA | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | AST > 20*ULN | 0 percentage of participants |
| Monotherapy Period: GA | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | Total Bilirubin > 1.5*ULN | 4 percentage of participants |
| Monotherapy Period: GA | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | GGT ≤ 1*ULN | 85 percentage of participants |
| Monotherapy Period: GA | Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy | GGT > 10*ULN | 0 percentage of participants |
Primary
Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy
Percentage of participants with potentially clinically significant hematology laboratory abnormalities.
Time frame: collected from the start of BG00012 administration through to Week 26 +/- 5 days
Population: Participants in the safety population with at least one post-baseline value. Safety Population for the Combination Therapy Period was defined as any participant who took at least 1 capsule of BG00012 concurrently with the background therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Monotherapy Period: IFNß | Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy | Lymphocytes < 0.8*10^9/L | 32 percentage of participants |
| Monotherapy Period: IFNß | Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy | Neutrophils ≥ 12*10^9/L | 2 percentage of participants |
| Monotherapy Period: IFNß | Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy | Lymphocytes > 12*10^9/L | 0 percentage of participants |
| Monotherapy Period: IFNß | Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy | Red Blood Cells ≤ 3.3*10^12/L | 0 percentage of participants |
| Monotherapy Period: IFNß | Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy | White Blood Cells (total) ≥ 16*10^9/L | 2 percentage of participants |
| Monotherapy Period: IFNß | Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy | Red Blood Cells ≥ 6.8*10^12/L | 0 percentage of participants |
| Monotherapy Period: IFNß | Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy | Neutrophils ≤ 1.0*10^9/L | 0 percentage of participants |
| Monotherapy Period: IFNß | Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy | Hemoglobin g/L ≤ 100 | 0 percentage of participants |
| Monotherapy Period: IFNß | Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy | Lymphocytes < 0.5*10^9/L | 7 percentage of participants |
| Monotherapy Period: IFNß | Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy | Platelet Count ≤ 100*10^9/L | 0 percentage of participants |
| Monotherapy Period: IFNß | Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy | Neutrophils < 1.5*10^9/L | 13 percentage of participants |
| Monotherapy Period: IFNß | Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy | Platelet Count ≥ 600*10^9/L | 0 percentage of participants |
| Monotherapy Period: IFNß | Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy | White Blood Cells (total) < 3.0*10^9/L | 9 percentage of participants |
| Monotherapy Period: GA | Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy | Platelet Count ≥ 600*10^9/L | 0 percentage of participants |
| Monotherapy Period: GA | Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy | White Blood Cells (total) < 3.0*10^9/L | 2 percentage of participants |
| Monotherapy Period: GA | Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy | White Blood Cells (total) ≥ 16*10^9/L | 2 percentage of participants |
| Monotherapy Period: GA | Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy | Lymphocytes < 0.8*10^9/L | 6 percentage of participants |
| Monotherapy Period: GA | Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy | Lymphocytes < 0.5*10^9/L | 4 percentage of participants |
| Monotherapy Period: GA | Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy | Lymphocytes > 12*10^9/L | 0 percentage of participants |
| Monotherapy Period: GA | Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy | Neutrophils ≤ 1.0*10^9/L | 0 percentage of participants |
| Monotherapy Period: GA | Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy | Neutrophils < 1.5*10^9/L | 2 percentage of participants |
| Monotherapy Period: GA | Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy | Neutrophils ≥ 12*10^9/L | 4 percentage of participants |
| Monotherapy Period: GA | Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy | Red Blood Cells ≤ 3.3*10^12/L | 0 percentage of participants |
| Monotherapy Period: GA | Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy | Red Blood Cells ≥ 6.8*10^12/L | 0 percentage of participants |
| Monotherapy Period: GA | Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy | Hemoglobin g/L ≤ 100 | 0 percentage of participants |
| Monotherapy Period: GA | Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy | Platelet Count ≤ 100*10^9/L | 0 percentage of participants |
Primary
Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period)
An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the study drug. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose: resulted in death; in the view of the Investigator, placed the participant at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; was any other medically important event that, in the opinion of the Investigator, jeopardized the participant or required intervention to prevent one of the other outcomes above. TEAE was defined as having an onset date that was on or after the start of study treatment (BG00012), or that worsened after the start of study treatment.
Time frame: AEs were collected from enrollment until the final study visit (Week 26 +/-5 days).
Population: The Safety Population for the Combination Therapy Period was defined as any participant who took at least 1 capsule of BG00012 concurrently with the background therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Monotherapy Period: IFNß | Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period) | Participants discontinuing BG00012 due to a TEAE | 14 percentage of participants |
| Monotherapy Period: IFNß | Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period) | Participants with a related TEAE | 74 percentage of participants |
| Monotherapy Period: IFNß | Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period) | Participants withdrawing from study due to a TEAE | 14 percentage of participants |
| Monotherapy Period: IFNß | Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period) | Participants with a moderate or severe TEAE | 72 percentage of participants |
| Monotherapy Period: IFNß | Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period) | Participants with a TEAE | 95 percentage of participants |
| Monotherapy Period: IFNß | Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period) | Participants with a serious TEAE | 4 percentage of participants |
| Monotherapy Period: IFNß | Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period) | Participants with a severe TEAE | 14 percentage of participants |
| Monotherapy Period: GA | Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period) | Participants with a severe TEAE | 15 percentage of participants |
| Monotherapy Period: GA | Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period) | Participants with a related TEAE | 87 percentage of participants |
| Monotherapy Period: GA | Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period) | Participants with a serious TEAE | 2 percentage of participants |
| Monotherapy Period: GA | Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period) | Participants discontinuing BG00012 due to a TEAE | 17 percentage of participants |
| Monotherapy Period: GA | Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period) | Participants withdrawing from study due to a TEAE | 17 percentage of participants |
| Monotherapy Period: GA | Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period) | Participants with a moderate or severe TEAE | 70 percentage of participants |
| Monotherapy Period: GA | Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period) | Participants with a TEAE | 100 percentage of participants |
Primary
Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy
Percentage of participants with post-baseline values for selected urinalysis parameters requiring further evaluation. For urine microscopy, results were categorized for male and female participants. For males, normal/negative was considered 0 to 3 red blood cells/high-power field (rbc/hpf), and positive was categorized in the following stages: 4 to 10, 11 to 20, 21 to 149, and ≥ 150 rbc/hpf. For females, normal/negative was considered 0 to 8 rbc/hpf, and positive was categorized in the following stages: 9 to 20, 21 to 30, 31 to 149, and ≥ 150 rbc/hpf.
Time frame: collected from the start of BG00012 administration through to Week 26 +/- 5 days
Population: The Safety Population for the Combination Therapy Period was defined as any participant who took at least 1 capsule of BG00012 concurrently with the background therapy; n=participants in the safety population with at least 1 post-baseline value.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Monotherapy Period: IFNß | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine protein: 2+; n=57, 47 | 0 percentage of participants |
| Monotherapy Period: IFNß | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine ketone: normal/negative; n=57, 47 | 47 percentage of participants |
| Monotherapy Period: IFNß | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine protein: normal/negative; n=57, 47 | 39 percentage of participants |
| Monotherapy Period: IFNß | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine ketone: trace; n=57, 47 | 9 percentage of participants |
| Monotherapy Period: IFNß | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine protein: 3+; n=57, 47 | 0 percentage of participants |
| Monotherapy Period: IFNß | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine ketone: 1+; n=57, 47 | 26 percentage of participants |
| Monotherapy Period: IFNß | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine protein: 4+; n=57, 47 | 0 percentage of participants |
| Monotherapy Period: IFNß | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine ketone: 2+; n=57, 47 | 11 percentage of participants |
| Monotherapy Period: IFNß | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine blood: 2+; n=57, 47 | 7 percentage of participants |
| Monotherapy Period: IFNß | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine ketone: 3+; n=57, 47 | 4 percentage of participants |
| Monotherapy Period: IFNß | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine glucose: normal/negative; n=57, 47 | 93 percentage of participants |
| Monotherapy Period: IFNß | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine ketone: 4+; n=57, 47 | 4 percentage of participants |
| Monotherapy Period: IFNß | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine protein: trace; n=57, 47 | 35 percentage of participants |
| Monotherapy Period: IFNß | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine microscopy (male): 0-3 rbc/hpf; n=9, 16 | 100 percentage of participants |
| Monotherapy Period: IFNß | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine glucose: trace; n=57, 47 | 2 percentage of participants |
| Monotherapy Period: IFNß | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine microscopy (male): 4-10 rbc/hpf; n=9, 16 | 0 percentage of participants |
| Monotherapy Period: IFNß | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine blood: 1+; n=57, 47 | 5 percentage of participants |
| Monotherapy Period: IFNß | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine microscopy (male): 11-20 rbc/hpf; n=9, 16 | 0 percentage of participants |
| Monotherapy Period: IFNß | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine glucose: 1+; n=57, 47 | 2 percentage of participants |
| Monotherapy Period: IFNß | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine microscopy (male): 21-149 rbc/hpf; n=9, 16 | 0 percentage of participants |
| Monotherapy Period: IFNß | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine protein: 1+; n=57, 47 | 26 percentage of participants |
| Monotherapy Period: IFNß | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine microscopy (male): ≥ 150 rbc/hpf; n=9, 16 | 0 percentage of participants |
| Monotherapy Period: IFNß | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine glucose: 2+; n=57, 47 | 0 percentage of participants |
| Monotherapy Period: IFNß | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine microscopy (female): 0-8 rbc/hpf; n=25, 28 | 76 percentage of participants |
| Monotherapy Period: IFNß | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine blood: 3+; n=57, 47 | 5 percentage of participants |
| Monotherapy Period: IFNß | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine microscopy (female): 9-20 rbc/hpf; n=25, 28 | 8 percentage of participants |
| Monotherapy Period: IFNß | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine glucose: 3+; n=57, 47 | 2 percentage of participants |
| Monotherapy Period: IFNß | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine microscopy (female): 21-30 rbc/hpf; n=25, 28 | 4 percentage of participants |
| Monotherapy Period: IFNß | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine blood: trace; n=57, 47 | 7 percentage of participants |
| Monotherapy Period: IFNß | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine microscopy (female): 31-149 rbc/hpf;n=25, 28 | 0 percentage of participants |
| Monotherapy Period: IFNß | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine glucose: 4+; n=57, 47 | 2 percentage of participants |
| Monotherapy Period: IFNß | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine microscopy (female): ≥150 rbc/hpf; n=25, 28 | 12 percentage of participants |
| Monotherapy Period: IFNß | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine blood: normal/negative; n=57, 47 | 75 percentage of participants |
| Monotherapy Period: GA | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine microscopy (female): ≥150 rbc/hpf; n=25, 28 | 4 percentage of participants |
| Monotherapy Period: GA | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine blood: normal/negative; n=57, 47 | 64 percentage of participants |
| Monotherapy Period: GA | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine blood: trace; n=57, 47 | 9 percentage of participants |
| Monotherapy Period: GA | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine blood: 1+; n=57, 47 | 15 percentage of participants |
| Monotherapy Period: GA | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine blood: 2+; n=57, 47 | 11 percentage of participants |
| Monotherapy Period: GA | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine blood: 3+; n=57, 47 | 2 percentage of participants |
| Monotherapy Period: GA | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine protein: normal/negative; n=57, 47 | 38 percentage of participants |
| Monotherapy Period: GA | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine protein: trace; n=57, 47 | 45 percentage of participants |
| Monotherapy Period: GA | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine protein: 1+; n=57, 47 | 15 percentage of participants |
| Monotherapy Period: GA | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine protein: 3+; n=57, 47 | 0 percentage of participants |
| Monotherapy Period: GA | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine protein: 2+; n=57, 47 | 2 percentage of participants |
| Monotherapy Period: GA | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine protein: 4+; n=57, 47 | 0 percentage of participants |
| Monotherapy Period: GA | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine glucose: normal/negative; n=57, 47 | 94 percentage of participants |
| Monotherapy Period: GA | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine glucose: trace; n=57, 47 | 0 percentage of participants |
| Monotherapy Period: GA | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine glucose: 1+; n=57, 47 | 2 percentage of participants |
| Monotherapy Period: GA | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine glucose: 2+; n=57, 47 | 4 percentage of participants |
| Monotherapy Period: GA | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine glucose: 3+; n=57, 47 | 0 percentage of participants |
| Monotherapy Period: GA | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine glucose: 4+; n=57, 47 | 0 percentage of participants |
| Monotherapy Period: GA | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine ketone: normal/negative; n=57, 47 | 57 percentage of participants |
| Monotherapy Period: GA | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine ketone: trace; n=57, 47 | 11 percentage of participants |
| Monotherapy Period: GA | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine ketone: 1+; n=57, 47 | 28 percentage of participants |
| Monotherapy Period: GA | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine ketone: 2+; n=57, 47 | 4 percentage of participants |
| Monotherapy Period: GA | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine ketone: 3+; n=57, 47 | 0 percentage of participants |
| Monotherapy Period: GA | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine ketone: 4+; n=57, 47 | 0 percentage of participants |
| Monotherapy Period: GA | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine microscopy (male): 0-3 rbc/hpf; n=9, 16 | 75 percentage of participants |
| Monotherapy Period: GA | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine microscopy (male): 4-10 rbc/hpf; n=9, 16 | 6 percentage of participants |
| Monotherapy Period: GA | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine microscopy (male): 11-20 rbc/hpf; n=9, 16 | 13 percentage of participants |
| Monotherapy Period: GA | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine microscopy (male): 21-149 rbc/hpf; n=9, 16 | 6 percentage of participants |
| Monotherapy Period: GA | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine microscopy (male): ≥ 150 rbc/hpf; n=9, 16 | 0 percentage of participants |
| Monotherapy Period: GA | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine microscopy (female): 0-8 rbc/hpf; n=25, 28 | 86 percentage of participants |
| Monotherapy Period: GA | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine microscopy (female): 9-20 rbc/hpf; n=25, 28 | 4 percentage of participants |
| Monotherapy Period: GA | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine microscopy (female): 21-30 rbc/hpf; n=25, 28 | 0 percentage of participants |
| Monotherapy Period: GA | Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy | Urine microscopy (female): 31-149 rbc/hpf;n=25, 28 | 7 percentage of participants |
Other Pre-specified
Average Number of Gadolinium (Gd)-Enhancing Lesions: Week -8, -4, 0 Average Versus Week 16, 20, 24 Average
The average is calculated as (total number of lesions in non-missing scans / number of non-missing magnetic resonance imaging \[MRI\] scans).
Time frame: Week -8 through Week 24
Population: Gd cohort: BG00012-dosed participants with at least 1 Gd-enhancing lesion in any 1 of the 3 scans (Weeks -8, -4, or 0) during the Monotherapy Period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Monotherapy Period: IFNß | Average Number of Gadolinium (Gd)-Enhancing Lesions: Week -8, -4, 0 Average Versus Week 16, 20, 24 Average | Average number of lesions from Weeks -8, -4, 0 | 1.06 lesions | Standard Deviation 1.011 |
| Monotherapy Period: IFNß | Average Number of Gadolinium (Gd)-Enhancing Lesions: Week -8, -4, 0 Average Versus Week 16, 20, 24 Average | Average number of lesions from Weeks 16, 20, 24 | 0.17 lesions | Standard Deviation 0.243 |
| Monotherapy Period: IFNß | Average Number of Gadolinium (Gd)-Enhancing Lesions: Week -8, -4, 0 Average Versus Week 16, 20, 24 Average | Change from average of Weeks -8, -4, 0 | -0.90 lesions | Standard Deviation 0.902 |
| Monotherapy Period: GA | Average Number of Gadolinium (Gd)-Enhancing Lesions: Week -8, -4, 0 Average Versus Week 16, 20, 24 Average | Average number of lesions from Weeks -8, -4, 0 | 1.72 lesions | Standard Deviation 1.098 |
| Monotherapy Period: GA | Average Number of Gadolinium (Gd)-Enhancing Lesions: Week -8, -4, 0 Average Versus Week 16, 20, 24 Average | Average number of lesions from Weeks 16, 20, 24 | 0.83 lesions | Standard Deviation 2.115 |
| Monotherapy Period: GA | Average Number of Gadolinium (Gd)-Enhancing Lesions: Week -8, -4, 0 Average Versus Week 16, 20, 24 Average | Change from average of Weeks -8, -4, 0 | -0.89 lesions | Standard Deviation 2.264 |
Comparison: Change from average of Weeks -8, -4, and 0 to average of Weeks 16, 20, 24 MRI scans.p-value: <0.000195% CI: [-1.17, -0.33]Wilcoxon signed rank test
Comparison: Change from average of Weeks -8, -4, and 0 to average of Weeks 16, 20, 24 MRI scans.p-value: 0.012495% CI: [-1.83, -0.33]Wilcoxon signed rank test
Other Pre-specified
Average Number of New Gd-Enhancing Lesions: Weeks -4, 0 Average Versus Weeks 20, 24 Average
The average is calculated as (total number of lesions in non-missing scans / number of non-missing MRI scans).
Time frame: Week -4 through Week 24
Population: Gd cohort: BG00012-dosed participants with at least 1 Gd-enhancing lesion in any 1 of the 3 scans (Weeks -8, -4, or 0) during the Monotherapy Period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Monotherapy Period: IFNß | Average Number of New Gd-Enhancing Lesions: Weeks -4, 0 Average Versus Weeks 20, 24 Average | Average number of lesions from Weeks -4, 0 | 0.91 lesions | Standard Deviation 0.953 |
| Monotherapy Period: IFNß | Average Number of New Gd-Enhancing Lesions: Weeks -4, 0 Average Versus Weeks 20, 24 Average | Average number of lesions from Weeks 20, 24 | 0.06 lesions | Standard Deviation 0.171 |
| Monotherapy Period: IFNß | Average Number of New Gd-Enhancing Lesions: Weeks -4, 0 Average Versus Weeks 20, 24 Average | Change from average of Weeks -4, 0 | -0.84 lesions | Standard Deviation 0.978 |
| Monotherapy Period: GA | Average Number of New Gd-Enhancing Lesions: Weeks -4, 0 Average Versus Weeks 20, 24 Average | Average number of lesions from Weeks -4, 0 | 0.79 lesions | Standard Deviation 0.985 |
| Monotherapy Period: GA | Average Number of New Gd-Enhancing Lesions: Weeks -4, 0 Average Versus Weeks 20, 24 Average | Average number of lesions from Weeks 20, 24 | 0.18 lesions | Standard Deviation 0.303 |
| Monotherapy Period: GA | Average Number of New Gd-Enhancing Lesions: Weeks -4, 0 Average Versus Weeks 20, 24 Average | Change from average of Weeks -4, 0 | -0.62 lesions | Standard Deviation 1.054 |
Comparison: Change from average of Weeks -4, and 0 to average of Weeks 20, 24 MRI scans.p-value: 0.00195% CI: [-1.5, -0.25]Wilcoxon signed rank test
Comparison: Change from average of Weeks -4, and 0 to average of Weeks 20, 24 MRI scans.p-value: 0.033995% CI: [-1.25, 0]Wilcoxon signed rank test
Other Pre-specified
Number of New or Newly Enlarging T2 Lesions
The number of new T2 lesions divided by the number of months since the reference visit during the Monotherapy Period and the Add-On Therapy Period.
Time frame: Week -8 to Week 24
Population: Number of participants in the Gd cohort with analyzable data in both Monotherapy and Add-on Therapy Periods. Gd cohort: BG00012-dosed participants with at least 1 Gd-enhancing lesion in any 1 of the 3 scans (Weeks -8, -4, or 0) during the Monotherapy Period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Monotherapy Period: IFNß | Number of New or Newly Enlarging T2 Lesions | New lesions in the Monotherapy Period | 1.23 lesions per month | Standard Deviation 1.498 |
| Monotherapy Period: IFNß | Number of New or Newly Enlarging T2 Lesions | New lesions in the Add-on Therapy Period | 0.67 lesions per month | Standard Deviation 1.257 |
| Monotherapy Period: GA | Number of New or Newly Enlarging T2 Lesions | New lesions in the Monotherapy Period | 0.89 lesions per month | Standard Deviation 1.243 |
| Monotherapy Period: GA | Number of New or Newly Enlarging T2 Lesions | New lesions in the Add-on Therapy Period | 0.25 lesions per month | Standard Deviation 0.293 |
Other Pre-specified
Summary of Adverse Events (AEs) Occurring Before BG00012 Dosing (Monotherapy Period)
Percentage of participants with AEs, serious AEs (SAEs), and discontinuations due to AEs. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the study drug. An SAE was any untoward medical occurrence that, at any dose: resulted in death; in the view of the Investigator, placed the participant at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; was any other medically important event that, in the opinion of the Investigator, jeopardized the participant or required intervention to prevent one of the other outcomes above. AEs were categorized as mild, moderate, or severe. All AEs occurring from enrollment to the day before BG00012 dosing are included.
Time frame: from time of enrollment until day before first administration of BG00012 (Week -8 to Week 0)
Population: The Safety Population for the Monotherapy Period was defined as any participant who took at least 1 dose of background therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Monotherapy Period: IFNß | Summary of Adverse Events (AEs) Occurring Before BG00012 Dosing (Monotherapy Period) | Participants with a moderate or severe AE | 22 percentage of participants |
| Monotherapy Period: IFNß | Summary of Adverse Events (AEs) Occurring Before BG00012 Dosing (Monotherapy Period) | Participants with an SAE | 0 percentage of participants |
| Monotherapy Period: IFNß | Summary of Adverse Events (AEs) Occurring Before BG00012 Dosing (Monotherapy Period) | Participants with a severe AE | 3 percentage of participants |
| Monotherapy Period: IFNß | Summary of Adverse Events (AEs) Occurring Before BG00012 Dosing (Monotherapy Period) | Participants withdrawing from study due to an AE | 0 percentage of participants |
| Monotherapy Period: IFNß | Summary of Adverse Events (AEs) Occurring Before BG00012 Dosing (Monotherapy Period) | Participants with an AE | 56 percentage of participants |
| Monotherapy Period: GA | Summary of Adverse Events (AEs) Occurring Before BG00012 Dosing (Monotherapy Period) | Participants withdrawing from study due to an AE | 0 percentage of participants |
| Monotherapy Period: GA | Summary of Adverse Events (AEs) Occurring Before BG00012 Dosing (Monotherapy Period) | Participants with an AE | 49 percentage of participants |
| Monotherapy Period: GA | Summary of Adverse Events (AEs) Occurring Before BG00012 Dosing (Monotherapy Period) | Participants with a moderate or severe AE | 27 percentage of participants |
| Monotherapy Period: GA | Summary of Adverse Events (AEs) Occurring Before BG00012 Dosing (Monotherapy Period) | Participants with a severe AE | 0 percentage of participants |
| Monotherapy Period: GA | Summary of Adverse Events (AEs) Occurring Before BG00012 Dosing (Monotherapy Period) | Participants with an SAE | 0 percentage of participants |