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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glatiramer acetate (GA) and dimethyl fumarate | Experimental | Participants taking a stable dose of GA for at least 12 months prior to the study remain on that dose throughout the study. Dimethyl fumarate is administered at 120 mg three times a day (TID) on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months). |
|
| Interferon beta (IFNβ) and dimethyl fumarate | Experimental | Participants taking a stable dose of one of the IFNβ products for at least 12 months prior to the study remain on that product and dose throughout the study. Dimethyl fumarate is administered at 120 mg three times a day (TID) on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dimethyl fumarate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | AEs were collected from enrollment until the final study visit (Week 26 +/-5 days). |
| Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy | Percentage of participants with potentially clinically significant hematology laboratory abnormalities. | collected from the start of BG00012 administration through to Week 26 +/- 5 days |
| 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. | collected from the start of BG00012 administration through to Week 26 +/- 5 days |
| Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Gilbert | Arizona | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27252601 | Background | Calkwood J, Vollmer T, Fox RJ, Zhang R, Novas M, Sheikh SI, Viglietta V. Safety and Tolerability of Delayed-Release Dimethyl Fumarate Administered with Interferon Beta or Glatiramer Acetate in Relapsing-Remitting Multiple Sclerosis. Int J MS Care. 2016 May-Jun;18(3):138-46. doi: 10.7224/1537-2073.2015-020. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Monotherapy Period: Interferon Beta (IFNß) | 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. The monotherapy period included the 8 weeks prior to the first dose of dimethyl fumarate. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 2-Month Monotherapy Period |
|
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|
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.
| collected from the start of BG00012 administration through to Week 26 +/- 5 days |
| from time of enrollment until day before first administration of BG00012 (Week -8 to Week 0) |
| 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). | Week -8 through Week 24 |
| 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). | Week -4 through Week 24 |
| 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. | Week -8 to Week 24 |
| Phoenix |
| Arizona |
| United States |
| Research Site | Danbury | Connecticut | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Fort Wayne | Indiana | United States |
| Research Site | Baltimore | Maryland | United States |
| Research Site | Boston | Massachusetts | United States |
| Research Site | Golden Valley | Minnesota | United States |
| Research Site | Teaneck | New Jersey | United States |
| Research Site | Patchogue | New York | United States |
| Research Site | Cleveland | Ohio | United States |
| Research Site | Dayton | Ohio | United States |
| Research Site | Portland | Oregon | United States |
| Research Site | Cordova | Tennessee | United States |
| Research Site | Franklin | Tennessee | United States |
| Research Site | Milwaukee | Wisconsin | United States |
| Monotherapy Period: Glatiramer Acetate (GA) |
Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. The monotherapy period included the 8 weeks prior to the first dose of dimethyl fumarate. |
| FG002 | Add-on Therapy Period: Dimethyl Fumarate Add-on to IFNß | BG00012 (dimethyl fumarate) was to be administered at 120 mg three times a day (TID) on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months) as an add-on to a stable dose of IFNß. 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. |
| FG003 | Add-on Therapy Period: Dimethyl Fumarate Add-on to GA | 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). Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| 6-month Add-on Therapy Period |
|
|
Intent-to-Treat (ITT) Population: participants who took at least 1 capsule of BG00012 concurrently with the background therapy (combination therapy).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The Safety Population for the Monotherapy Period was defined as any participant who took at least 1 dose of background therapy. | Posted | Number | percentage of participants | from time of enrollment until day before first administration of BG00012 (Week -8 to Week 0) |
|
|
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | percentage of participants | AEs were collected from enrollment until the final study visit (Week 26 +/-5 days). |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy | Percentage of participants with potentially clinically significant hematology laboratory abnormalities. | 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. | Posted | Number | percentage of participants | collected from the start of BG00012 administration through to Week 26 +/- 5 days |
| ||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | percentage of participants | collected from the start of BG00012 administration through to Week 26 +/- 5 days |
| ||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | percentage of participants | collected from the start of BG00012 administration through to Week 26 +/- 5 days |
| ||||||||||||||||||||||||||||||||||||||
| 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). | 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. | Posted | Mean | Standard Deviation | lesions | Week -8 through Week 24 |
| |||||||||||||||||||||||||||||||||||||
| 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). | 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. | Posted | Mean | Standard Deviation | lesions | Week -4 through Week 24 |
|
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | lesions per month | Week -8 to Week 24 |
|
AEs for the Monotherapy Period collected from enrollment until prior to administration of BG00012. TEAEs for the Add-on Therapy Period collected from start of BG00012 until the final study visit (Week 26 +/-5 days).
AEs for the Monotherapy Period were summarized for all enrolled participants and were included for completeness only. No direct comparisons were made between the 2-month Monotherapy and the 6-month Add-on Therapy Periods due to the difference in the length of observation between these 2 periods.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Monotherapy Period: IFNß | A stable dose of one of the IFNß products for up to 8 weeks (until the first dose of BG00012). | 0 | 59 | 13 | 59 | ||
| EG001 | Monotherapy Period: GA | A stable dose of GA for up to 8 weeks (until the first dose of BG00012). | 0 | 49 | 7 | 49 | ||
| EG002 | Add-on Therapy Period: IFNß and BG00012 | 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). | 2 | 57 | 53 | 57 | ||
| EG003 | Add-on Therapy Period: GA and BG00012 | 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). | 1 | 47 | 45 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clostridial infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Multiple Sclerosis Relapse | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Ear Infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Balance Disorder | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Decreased Vibratory Sense | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hot Flush | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase Increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| White Blood Cell Count Decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Lymphocyte Count Decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Biogen Study Medical Director | Biogen | clinicaltrials@biogen.com |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069462 | Dimethyl Fumarate |
| ID | Term |
|---|---|
| D005650 | Fumarates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Lost to Follow-up |
|
| Disease Activity |
|
| Physician Decision |
|
| Other |
|
| 20 to 29 years |
|
| 30 to 39 years |
|
| 40 to 49 years |
|
| 50 to 55 years |
|
| Male |
|
| Participants with a severe AE |
|
| Participants with an SAE |
|
| Participants withdrawing from study due to an AE |
|
| OG001 | 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). |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
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).
|
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| Units |
|---|
| Counts |
|---|
| Participants |
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| Participants |
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| Units | Counts |
|---|
| Participants |
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