Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001973-42 | EudraCT Number |
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The primary objective of the study is to evaluate the effect of BG00012 on lymphocyte subset counts during the first year of treatment in subjects with relapsing-remitting multiple sclerosis (RRMS). A secondary objective is to evaluate the pharmacodynamic effect on absolute lymphocyte counts (ALCs) and immunoglobulins (Igs) during the first year of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dimethyl fumarate | Experimental | 120 mg twice daily (BID) for the first 7 days and 240 mg BID thereafter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dimethyl fumarate | Drug | Initial oral dose for 7 days with maintenance dose thereafter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | Lymphocyte subsets include T cell, B cell and Natural killer (NK) cells. | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48 |
| Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | T-cells subsets includes Activated CD4+ T-cell, Activated CD8+ T-cell, Activated CD8+ T-cell [CD38+], Activated Th (T helper) 1 phenotype, Activated Th17 phenotype, Activated Th2-enriched phenotype, Activated CD4+ T-cell [CD38+HLA-DR+], Activated CD4+ T-cell [HLA-DR+], Activated CD8+ T-cell [HLA-DR+], Central Memory (CM) CD4+ T-cell [CD45RA-CCR7+], CM CD4+ T-cell [CD45RA-CCR7+], CM CD8+ T-cell [CD45RA-CCR7+], Effector CD4+ T-cell [CD45RA+CCR7-], Effector CD8+ T-cell [CD45RA+CCR7-], Effector Memory (EM) CD4+ T-cell [CD45RA-CCR7-], EM CD8+ T-cell [CD45RA-CCR7-], Effector Regulatory T-cells, Effector CD4+ T-cell [CD45RA+CCR7-], Effector CD8+ T-cell [CD45RA+CCR7-], Naïve CD4+ T-cell [CD45RA+], Naïve CD8+ T-cell [CD45RA+], Naïve (N) CD8+ T-cell [CD45RA+], Naïve Regulatory T-cells, Terminal Effector Regulatory T-cells, Th1 phenotype, Th17 phenotype, Th2-enriched phenotype. Here, Change at week is represented as CW. | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48 |
| Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | B-cell subsets include CD10+ Transitional B cells, CD138+ Plasma Cells, Ig (Immunoglobulin) D+ Memory B cells [non-class switched], IgD- Memory B cells [class switched], Naïve B cells, Plasma Cells [CD10-], Transitional B-cells and Plasmablasts. Here, Change at week is represented as CW. | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48 |
| Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Myeloid and natural killer cell subsets include CD56Bright NK cells, CD56Dim NK cells, Classical Monocytes, Myeloid dendritic cells, Non-classical Monocytes, Plasmacytoid dendritic cells, Total dendritic cells and Total monocytes [CD14+]. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Immunoglobulin A (IgA) up to 48 Weeks | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48 | |
| Change From Baseline in Immunoglobulin M (IgM) up to 48 Weeks | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48 |
Not provided
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 | 85234 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39570545 | Derived | Mao-Draayer Y, Bar-Or A, Balashov K, Foley J, Smoot K, Longbrake EE, Robertson D, Mendoza JP, Lewin JB, Everage N, Bozin I, Lyons J, Mokliatchouk O, Bame E, Giuliani F. Real-World Safety and Effectiveness of Dimethyl Fumarate in Patients with MS: Results from the ESTEEM Phase 4 and PROCLAIM Phase 3 Studies with a Focus on Older Patients. Adv Ther. 2025 Jan;42(1):395-412. doi: 10.1007/s12325-024-03047-w. Epub 2024 Nov 21. |
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A total of 218 participants were enrolled in the study of which 158 participants completed the study
This study was conducted from 11 August 2015 to 23 April 2018 in Belgium, Bulgaria, Lithuania, Kuwait, Poland and United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Dimethyl Fumarate (BG00012) | Participants received 120 mg BID orally for the first 7 days and 240 mg BID thereafter until 96 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 22, 2016 | Apr 23, 2019 |
Not provided
Not provided
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Not provided
| Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48 |
| Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | T-cell cytokine subsets include IFN (interferon) g+ (% of CD4+ T cells), IFNg+ (% of CD8+ T cells), IFNg+ (% of memory CD4+ T cells), IFNg+ (% of memory CD8+ T cells), IL- (interleukin) 17A+/IFNg- (% of CD4+ T cells), IL-17A+/IFNg- (% of CD8+ T cells), IL-17A+/IFNg- (% of memory CD4+ T cells), IL-17A+/IFNg- (% of memory CD8+ T cells), IL-2+ (% of CD4+ T cells), IL-2+ (% of CD8+ T cells), IL-2+ (% of memory CD4+ T cells), IL-2+ (% of memory CD8+ T cells), IL-4+ (% of CD4+ T cells), IL-4+ (% of CD8+ T cells), IL-4+ (% of memory CD4+ T cells) and IL-4+ (% of memory CD8+ T cells). Here, Change at week is represented as CW. | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48 |
| Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen | VLA-4/LFA-1 antigen subsets include CD11a+ (% of B cells), CD11a+ (% of T cells), CD11a+ (% of MNC), CD11a+ (% of dendritic cells [CD11c++]), CD11a+ (% of lymphocytes), CD11a+ (% of monocytes), CD11a+ (% of neutrophils), CD49d+ (% of B cells), CD49d+ (% of T cells), CD49d+ (% of MNC), CD49d+ (% of dendritic cells [CD11c++]), CD49d+ (% of lymphocytes), CD49d+ (% of monocytes) and CD49d+ (% of neutrophils). | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48 |
| Change From Baseline in Immunoglobulin G (IgG) up to 48 Weeks | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48 |
| Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48 |
| Long Beach |
| California |
| 90806 |
| United States |
| Research Site | Ocala | Florida | 34471 | United States |
| Research Site | Oldsmar | Florida | 34677 | United States |
| Research Site | Tampa | Florida | 33609 | United States |
| Research Site | Tampa | Florida | 33612 | United States |
| Research Site | Atlanta | Georgia | 30342 | United States |
| Research Site | Overland Park | Kansas | 66212 | United States |
| Research Site | Baltimore | Maryland | 33612 | United States |
| Research Site | Traverse City | Michigan | 49684 | United States |
| Research Site | Raleigh | North Carolina | 27607 | United States |
| Research Site | Spartanburg | South Carolina | 29307 | United States |
| Research Site | San Antonio | Texas | 78258 | United States |
| Research Site | Salt Lake City | Utah | 84103 | United States |
| Research Site | Tacoma | Washington | 98405 | United States |
| Research Site | La Louvière | Hainaut | 7100 | Belgium |
| Research Site | Bruges | West-Vlaanderen | 8000 | Belgium |
| Research Site | Brasschaat | 2930 | Belgium |
| Research Site | Plaven | 5800 | Bulgaria |
| Research Site | Pleven | 5800 | Bulgaria |
| Research Site | Sofia | 1113 | Bulgaria |
| Research Site | Sofia | 1606 | Bulgaria |
| Research Site | Sofia | Bulgaria |
| Research Site | Kuwait City | 00001 | Kuwait |
| Research Site | Kaunas | LT-50009 | Lithuania |
| Research Site | Klaipėda | 92288 | Lithuania |
| Research Site | Vilnius | LT-08661 | Lithuania |
| Research Site | Bydgoszcz | 85-795 | Poland |
| Research Site | Katowice | 40-595 | Poland |
| Research Site | Katowice | 40-650 | Poland |
| Research Site | Lodz | 90-324 | Poland |
| Research Site | Plewiska | 62-064 | Poland |
| Research Site | Szczecin | 70-215 | Poland |
| Research Site | Umuttepe | Kocaeli | 41380 | Turkey (Türkiye) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The pharmacodynamic (PD) population was defined as all participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement after baseline.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dimethyl Fumarate (BG00012) | Participants received 120 mg BID orally for the first 7 days and 240 mg BID thereafter until 96 weeks. |
| 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 |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | 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 | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | Lymphocyte subsets include T cell, B cell and Natural killer (NK) cells. | The PD population was defined as all participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement after baseline. Here 'Number analyzed' signifies number of participants analyzed at specified timepoint for each subset. | Posted | Mean | Standard Deviation | cells per cubic millimeter (cells/mm^3) | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48 |
|
|
| |||||||||||||||||||||||||||
| Primary | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | T-cells subsets includes Activated CD4+ T-cell, Activated CD8+ T-cell, Activated CD8+ T-cell [CD38+], Activated Th (T helper) 1 phenotype, Activated Th17 phenotype, Activated Th2-enriched phenotype, Activated CD4+ T-cell [CD38+HLA-DR+], Activated CD4+ T-cell [HLA-DR+], Activated CD8+ T-cell [HLA-DR+], Central Memory (CM) CD4+ T-cell [CD45RA-CCR7+], CM CD4+ T-cell [CD45RA-CCR7+], CM CD8+ T-cell [CD45RA-CCR7+], Effector CD4+ T-cell [CD45RA+CCR7-], Effector CD8+ T-cell [CD45RA+CCR7-], Effector Memory (EM) CD4+ T-cell [CD45RA-CCR7-], EM CD8+ T-cell [CD45RA-CCR7-], Effector Regulatory T-cells, Effector CD4+ T-cell [CD45RA+CCR7-], Effector CD8+ T-cell [CD45RA+CCR7-], Naïve CD4+ T-cell [CD45RA+], Naïve CD8+ T-cell [CD45RA+], Naïve (N) CD8+ T-cell [CD45RA+], Naïve Regulatory T-cells, Terminal Effector Regulatory T-cells, Th1 phenotype, Th17 phenotype, Th2-enriched phenotype. Here, Change at week is represented as CW. | The PD population was defined as all participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement after baseline. Here 'Number analyzed' signifies number of participants analyzed at specified timepoint for each subset. | Posted | Mean | Standard Deviation | cells/mm^3 | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48 |
| |||||||||||||||||||||||||||||
| Primary | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | B-cell subsets include CD10+ Transitional B cells, CD138+ Plasma Cells, Ig (Immunoglobulin) D+ Memory B cells [non-class switched], IgD- Memory B cells [class switched], Naïve B cells, Plasma Cells [CD10-], Transitional B-cells and Plasmablasts. Here, Change at week is represented as CW. | The PD population was defined as all participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement after baseline. Here 'Number analyzed' signifies number of participants analyzed at specified timepoint for each subset. | Posted | Mean | Standard Deviation | cells/mm^3 | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48 |
|
| ||||||||||||||||||||||||||||
| Primary | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Myeloid and natural killer cell subsets include CD56Bright NK cells, CD56Dim NK cells, Classical Monocytes, Myeloid dendritic cells, Non-classical Monocytes, Plasmacytoid dendritic cells, Total dendritic cells and Total monocytes [CD14+]. | The PD population was defined as all participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement after baseline. Here 'Number analyzed' signifies number of participants analyzed at specified timepoint for each subset. | Posted | Mean | Standard Deviation | cells/mm^3 | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48 |
|
| ||||||||||||||||||||||||||||
| Primary | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | T-cell cytokine subsets include IFN (interferon) g+ (% of CD4+ T cells), IFNg+ (% of CD8+ T cells), IFNg+ (% of memory CD4+ T cells), IFNg+ (% of memory CD8+ T cells), IL- (interleukin) 17A+/IFNg- (% of CD4+ T cells), IL-17A+/IFNg- (% of CD8+ T cells), IL-17A+/IFNg- (% of memory CD4+ T cells), IL-17A+/IFNg- (% of memory CD8+ T cells), IL-2+ (% of CD4+ T cells), IL-2+ (% of CD8+ T cells), IL-2+ (% of memory CD4+ T cells), IL-2+ (% of memory CD8+ T cells), IL-4+ (% of CD4+ T cells), IL-4+ (% of CD8+ T cells), IL-4+ (% of memory CD4+ T cells) and IL-4+ (% of memory CD8+ T cells). Here, Change at week is represented as CW. | The PD population was defined as all participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement after baseline. Here 'Number analyzed' signifies number of participants analyzed at specified timepoint for each subset. | Posted | Mean | Standard Deviation | cells/mm^3 | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48 |
|
| ||||||||||||||||||||||||||||
| Primary | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen | VLA-4/LFA-1 antigen subsets include CD11a+ (% of B cells), CD11a+ (% of T cells), CD11a+ (% of MNC), CD11a+ (% of dendritic cells [CD11c++]), CD11a+ (% of lymphocytes), CD11a+ (% of monocytes), CD11a+ (% of neutrophils), CD49d+ (% of B cells), CD49d+ (% of T cells), CD49d+ (% of MNC), CD49d+ (% of dendritic cells [CD11c++]), CD49d+ (% of lymphocytes), CD49d+ (% of monocytes) and CD49d+ (% of neutrophils). | The PD population was defined as all participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement after baseline. Here 'Number analyzed' signifies number of participants analyzed at specified timepoint for each subset. | Posted | Mean | Standard Deviation | cells/mm^3 | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48 |
|
| ||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Immunoglobulin A (IgA) up to 48 Weeks | The PD population was defined as all participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement after baseline. Here 'number analyzed' signifies number of participants analyzed at each timepoint. | Posted | Mean | Standard Deviation | milligram per liter (mg/L) | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Immunoglobulin M (IgM) up to 48 Weeks | The PD population was defined as all participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement after baseline. Here 'number analyzed' signifies number of participants analyzed at each timepoint. | Posted | Mean | Standard Deviation | mg/L | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Immunoglobulin G (IgG) up to 48 Weeks | The PD population was defined as all participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement after baseline. Here 'number analyzed' signifies number of participants analyzed at each timepoint. | Posted | Mean | Standard Deviation | g/L | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | The PD population was defined as all participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement after baseline. Here 'number analyzed' signifies number of participants analyzed at each timepoint. | Posted | Mean | Standard Deviation | milligram per deciliter | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48 |
|
|
Up to 33 months
The safety population was defined as all participants who received at least 1 dose of study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dimethyl Fumarate (BG00012) | Participants received 120 mg BID orally for the first 7 days and 240 mg BID thereafter until 96 weeks. | 0 | 218 | 26 | 218 | 160 | 218 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Iridocyclitis | Eye disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Breast cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.0 | Systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Neurological decompensation | Nervous system disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Anembryonic gestation | Pregnancy, puerperium and perinatal conditions | MedDRA v21.0 | Systematic Assessment |
| |
| Device malfunction | Product Issues | MedDRA v21.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA v21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA v21.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA v21.0 | 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 | |
|---|---|---|---|---|
| US Biogen Clinical Trial Center | Biogen | 866-633-4636 | clinicaltrials@biogen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 23, 2018 | Apr 23, 2019 | SAP_001.pdf |
| 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
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| B Cells: Change at Week 8 |
|
|
| B Cells: Change at Week 12 |
|
|
| B Cells: Change at Week 24 |
|
|
| B Cells: Change at Week 36 |
|
|
| B Cells: Change at Week 48 |
|
|
| NK Cells: Baseline |
|
|
| NK Cells: Change at Week 4 |
|
|
| NK Cells: Change at Week 8 |
|
|
| NK Cells: Change at Week 12 |
|
|
| NK Cells: Change at Week 24 |
|
|
| NK Cells: Change at Week 36 |
|
|
| NK Cells: Change at Week 48 |
|
|
| T Cells: Baseline |
|
|
| T Cells: Change at Week 4 |
|
|
| T Cells: Change at Week 8 |
|
|
| T Cells: Change at Week 12 |
|
|
| T Cells: Change at Week 24 |
|
|
| T Cells: Change at Week 36 |
|
|
| T Cells: Change at Week 48 |
|
|
| CD4+ T cells: Baseline |
|
|
| CD4+ T cells: Change at Week 4 |
|
|
| CD4+ T cells: Change at Week 8 |
|
|
| CD4+ T cells: Change at Week 12 |
|
|
| CD4+ T cells: Change at Week 24 |
|
|
| CD4+ T cells: Change at Week 36 |
|
|
| CD4+ T cells: Change at Week 48 |
|
|
| CD8+ T cells: Baseline |
|
|
| CD8+ T cells:Change at Week 4 |
|
|
| CD8+ T cells:Change at Week 8 |
|
|
| CD8+ T cells:Change at Week 12 |
|
|
| CD8+ T cells:Change at Week 24 |
|
|
| CD8+ T cells:Change at Week 36 |
|
|
| CD8+ T cells:Change at Week 48 |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|