Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
Conditions
Keywords
Tecfidera, DMF, dimethyl fumarate
Brief summary
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.
Interventions
DRUGdimethyl fumarate
Initial oral dose for 7 days with maintenance dose thereafter
Sponsors
Biogen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Subjects of childbearing potential (including female subjects who are post-menopausal for less than 1 year) must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment. * Must have a confirmed diagnosis of RRMS according to the revised McDonald criteria (2010) \[Polman 2011\] Key
Exclusion criteria
* History of or positive test result at Screening for: * human immunodeficiency virus * hepatitis C virus antibody * hepatitis B infection * Drug or alcohol abuse within 1 year prior to Screening. * Prior treatment with any of the following: * cladribine * mitoxantrone * total lymphoid irradiation * alemtuzumab * T-cell or T-cell receptor vaccination * any therapeutic monoclonal antibody, with the exception of natalizumab or daclizumab * Treatment with any of the following medications or procedures within 6 months prior to Baseline (Day 1): * DMF (given as Fumaderm®) or BG00012; enrollment will be limited to no more than 40 subjects (out of 200) with prior DMF exposure * cyclosporine * azathioprine * methotrexate * mycophenolate mofetil * intravenous (IV) Ig * plasmapheresis or cytapheresis NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48 | 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). |
| Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48 | 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. |
| Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48 | 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. |
| Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48 | 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 \[CD14+\]. |
| Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48 | 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. |
| Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48 | Lymphocyte subsets include T cell, B cell and Natural killer (NK) cells. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
Countries
Belgium, Bulgaria, Kuwait, Lithuania, Poland, Turkey (Türkiye), United States
Participant flow
Recruitment details
This study was conducted from 11 August 2015 to 23 April 2018 in Belgium, Bulgaria, Lithuania, Kuwait, Poland and United States.
Pre-assignment details
A total of 218 participants were enrolled in the study of which 158 participants completed the study
Participants by arm
| Arm | Count |
|---|---|
| Dimethyl Fumarate (BG00012) Participants received 120 mg BID orally for the first 7 days and 240 mg BID thereafter until 96 weeks. | 218 |
| Total | 218 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 17 |
| Overall Study | Alternative Treatment for MS | 2 |
| Overall Study | Consent withdrawn | 22 |
| Overall Study | Disease progression, defined by protocol | 2 |
| Overall Study | Disease relapse | 4 |
| Overall Study | Investigator Decision | 1 |
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | New lesions in Brain | 1 |
| Overall Study | Non-compliance with study drug | 3 |
| Overall Study | Other | 1 |
Baseline characteristics
| Characteristic | Dimethyl Fumarate (BG00012) |
|---|---|
| Age, Continuous | 42.1 years STANDARD_DEVIATION 10.99 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 66 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 146 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 145 Participants |
| Race (NIH/OMB) White | 60 Participants |
| Sex: Female, Male Female | 151 Participants |
| Sex: Female, Male Male | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 218 |
| other Total, other adverse events | 160 / 218 |
| serious Total, serious adverse events | 26 / 218 |
Outcome results
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.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | CD10+ Transitional B cells: Baseline | 9.4 cells/mm^3 | Standard Deviation 9.93 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | CD10+ Transitional B cells: Change at Week 4 | -1.2 cells/mm^3 | Standard Deviation 7.98 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | CD10+ Transitional B cells: Change at Week 8 | -0.4 cells/mm^3 | Standard Deviation 8.73 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | CD10+ Transitional B cells: Change at Week 12 | -0.4 cells/mm^3 | Standard Deviation 9.09 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | CD10+ Transitional B cells: Change at Week 24 | 3.6 cells/mm^3 | Standard Deviation 10.16 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | CD10+ Transitional B cells: Change at Week 36 | 2.8 cells/mm^3 | Standard Deviation 9.53 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | CD10+ Transitional B cells: Change at Week 48 | 5.7 cells/mm^3 | Standard Deviation 13.53 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | CD138+ Plasma Cells: Baseline | 0.26 cells/mm^3 | Standard Deviation 0.289 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | CD138+ Plasma Cells: Change at Week 4 | -0.02 cells/mm^3 | Standard Deviation 0.367 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | CD138+ Plasma Cells: Change at Week 8 | -0.12 cells/mm^3 | Standard Deviation 0.291 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | CD138+ Plasma Cells: Change at Week 12 | -0.15 cells/mm^3 | Standard Deviation 0.288 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | CD138+ Plasma Cells: Change at Week 24 | -0.21 cells/mm^3 | Standard Deviation 0.297 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | CD138+ Plasma Cells: Change at Week 36 | -0.21 cells/mm^3 | Standard Deviation 0.327 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | CD138+ Plasma Cells: Change at Week 48 | -0.19 cells/mm^3 | Standard Deviation 0.318 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | IgD+ Memory B cells [non-class switched]: Baseline | 37.8 cells/mm^3 | Standard Deviation 36.96 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | IgD+ Memory B cells[non-class switched]: CW 4 | -8.9 cells/mm^3 | Standard Deviation 26.18 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | IgD+ Memory B cells[non-class switched]: CW 8 | -12.4 cells/mm^3 | Standard Deviation 29.27 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | IgD+ Memory B cells[non-class switched]: CW 12 | -12.1 cells/mm^3 | Standard Deviation 29.13 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | IgD+ Memory B cells[non-class switched]: CW 24 | -17.6 cells/mm^3 | Standard Deviation 31.39 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | IgD+ Memory B cells[non-class switched]: CW 36 | -19.6 cells/mm^3 | Standard Deviation 31.61 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | IgD+ Memory B cells [non-class switched]: CW 48 | -13.4 cells/mm^3 | Standard Deviation 34.89 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | IgD- Memory B cells [class switched]: Baseline | 50.4 cells/mm^3 | Standard Deviation 56.97 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | IgD- Memory B cells [class switched]: CW 4 | -8.7 cells/mm^3 | Standard Deviation 32.2 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | IgD- Memory B cells [class switched]: CW 8 | -17.7 cells/mm^3 | Standard Deviation 44.42 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | IgD- Memory B cells [class switched]: CW 12 | -23.1 cells/mm^3 | Standard Deviation 44.76 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | IgD- Memory B cells [class switched]: CW 24 | -29.5 cells/mm^3 | Standard Deviation 49.95 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | IgD- Memory B cells [class switched]: CW 36 | 49.95 cells/mm^3 | Standard Deviation 32.64 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | IgD- Memory B cells [class switched]: CW 48 | -27.4 cells/mm^3 | Standard Deviation 38.33 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | Naïve B cells: Baseline | 197.2 cells/mm^3 | Standard Deviation 140.48 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | Naïve B cells: Change at Week 4 | -21.5 cells/mm^3 | Standard Deviation 82.43 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | Naïve B cells: Change at Week 8 | -37.2 cells/mm^3 | Standard Deviation 95.32 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | Naïve B cells: Change at Week 12 | -43.1 cells/mm^3 | Standard Deviation 99.72 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | Naïve B cells: Change at Week 24 | -45.7 cells/mm^3 | Standard Deviation 114.46 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | Naïve B cells: Change at Week 36 | -54.0 cells/mm^3 | Standard Deviation 94.94 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | Naïve B cells: Change at Week 48 | -35.6 cells/mm^3 | Standard Deviation 107.79 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | Plasma Cells [CD10-]: Baseline | 0.63 cells/mm^3 | Standard Deviation 0.668 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | Plasma Cells [CD10-]: Change at Week 4 | -0.02 cells/mm^3 | Standard Deviation 0.816 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | Plasma Cells [CD10-]: Change at Week 8 | -0.11 cells/mm^3 | Standard Deviation 0.643 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | Plasma Cells [CD10-]: Change at Week 12 | -0.18 cells/mm^3 | Standard Deviation 0.647 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | Plasma Cells [CD10-]: Change at Week 24 | -0.34 cells/mm^3 | Standard Deviation 0.649 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | Plasma Cells [CD10-]: Change at Week 36 | -0.33 cells/mm^3 | Standard Deviation 0.786 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | Plasma Cells [CD10-]: Change at Week 48 | -0.38 cells/mm^3 | Standard Deviation 0.633 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | Transitional B-cells: Baseline | 13.6 cells/mm^3 | Standard Deviation 13.61 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | Transitional B-cells: Change at Week 4 | -1.3 cells/mm^3 | Standard Deviation 11.44 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | Transitional B-cells: Change at Week 8 | 0.6 cells/mm^3 | Standard Deviation 12.97 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | Transitional B-cells: Change at Week 12 | 0.7 cells/mm^3 | Standard Deviation 13.41 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | Transitional B-cells: Change at Week 24 | 5.8 cells/mm^3 | Standard Deviation 15.6 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | Transitional B-cells: Change at Week 36 | 4.2 cells/mm^3 | Standard Deviation 13.2 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | Transitional B-cells: Change at Week 48 | 7.3 cells/mm^3 | Standard Deviation 18.56 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | Plasmablasts: Baseline | 0.91 cells/mm^3 | Standard Deviation 1.104 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | Plasmablasts: Change at Week 4 | -0.04 cells/mm^3 | Standard Deviation 1.12 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | Plasmablasts: Change at Week 8 | -0.21 cells/mm^3 | Standard Deviation 1.062 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | Plasmablasts: Change at Week 12 | -0.31 cells/mm^3 | Standard Deviation 1.024 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | Plasmablasts: Change at Week 24 | -0.46 cells/mm^3 | Standard Deviation 1.106 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | Plasmablasts: Change at Week 36 | -0.46 cells/mm^3 | Standard Deviation 1.228 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets | Plasmablasts: Change at Week 48 | -0.50 cells/mm^3 | Standard Deviation 1.084 |
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 \[CD14+\].
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | CD56Bright NK cells: Baseline | 14.0 cells/mm^3 | Standard Deviation 8.94 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | CD56Bright NK cells: Change at Week 4 | 1.8 cells/mm^3 | Standard Deviation 6.4 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | CD56Bright NK cells: Change at Week 8 | 1.8 cells/mm^3 | Standard Deviation 7.07 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | CD56Bright NK cells: Change at Week 12 | 1.3 cells/mm^3 | Standard Deviation 7.26 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | CD56Bright NK cells: Change at Week 24 | 2.1 cells/mm^3 | Standard Deviation 8.57 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | CD56Bright NK cells: Change at Week 36 | 2.3 cells/mm^3 | Standard Deviation 9.73 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | CD56Bright NK cells: Change at Week 48 | 2.1 cells/mm^3 | Standard Deviation 8.55 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | CD56Dim NK cells: Baseline | 192.9 cells/mm^3 | Standard Deviation 130.45 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | CD56Dim NK cells: Change at Week 4 | -2.0 cells/mm^3 | Standard Deviation 102.59 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | CD56Dim NK cells: Change at Week 8 | -17.2 cells/mm^3 | Standard Deviation 102.92 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | CD56Dim NK cells: Change at Week 12 | -31.4 cells/mm^3 | Standard Deviation 92.14 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | CD56Dim NK cells: Change at Week 24 | -50.7 cells/mm^3 | Standard Deviation 101.34 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | CD56Dim NK cells: Change at Week 36 | -61.1 cells/mm^3 | Standard Deviation 102.96 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | CD56Dim NK cells: Change at Week 48 | -68.5 cells/mm^3 | Standard Deviation 129.83 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Classical Monocytes: Baseline | 301.4 cells/mm^3 | Standard Deviation 153.48 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Classical Monocytes: Change at Week 4 | 7.5 cells/mm^3 | Standard Deviation 182.11 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Classical Monocytes: Change at Week 8 | 6.0 cells/mm^3 | Standard Deviation 165.07 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Classical Monocytes: Change at Week 12 | 9.3 cells/mm^3 | Standard Deviation 197.84 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Classical Monocytes: Change at Week 24 | -8.7 cells/mm^3 | Standard Deviation 151.23 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Classical Monocytes: Change at Week 36 | -1.5 cells/mm^3 | Standard Deviation 163.62 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Classical Monocytes: Change at Week 48 | -0.8 cells/mm^3 | Standard Deviation 153.24 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Myeloid dendritic cells: Baseline | 24.96 cells/mm^3 | Standard Deviation 16.315 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Myeloid dendritic cells: Change at Week 4 | 1.46 cells/mm^3 | Standard Deviation 18.111 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Myeloid dendritic cells: Change at Week 8 | -0.61 cells/mm^3 | Standard Deviation 17.67 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Myeloid dendritic cells: Change at Week 12 | -0.23 cells/mm^3 | Standard Deviation 17.932 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Myeloid dendritic cells: Change at Week 24 | 3.02 cells/mm^3 | Standard Deviation 17.882 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Myeloid dendritic cells: Change at Week 36 | 3.63 cells/mm^3 | Standard Deviation 18.779 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Myeloid dendritic cells: Change at Week 48 | -6.20 cells/mm^3 | Standard Deviation 17.78 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Non-classical Monocytes: Baseline | 32.0 cells/mm^3 | Standard Deviation 22.88 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Non-classical Monocytes: Change at Week 4 | 2.2 cells/mm^3 | Standard Deviation 29.82 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Non-classical Monocytes: Change at Week 8 | -1.9 cells/mm^3 | Standard Deviation 30.14 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Non-classical Monocytes: Change at Week 12 | -10.8 cells/mm^3 | Standard Deviation 23.82 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Non-classical Monocytes: Change at Week 24 | -6.9 cells/mm^3 | Standard Deviation 27.65 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Non-classical Monocytes: Change at Week 36 | -10.6 cells/mm^3 | Standard Deviation 24.24 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Non-classical Monocytes: Change at Week 48 | -9.2 cells/mm^3 | Standard Deviation 24.37 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Plasmacytoid dendritic cells: Baseline | 6.52 cells/mm^3 | Standard Deviation 4.617 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Plasmacytoid dendritic cells: Change at Week 4 | 0.00 cells/mm^3 | Standard Deviation 5.168 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Plasmacytoid dendritic cells: Change at Week 8 | 0.30 cells/mm^3 | Standard Deviation 6.427 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Plasmacytoid dendritic cells: Change at Week 12 | -0.86 cells/mm^3 | Standard Deviation 4.575 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Plasmacytoid dendritic cells: Change at Week 24 | -0.69 cells/mm^3 | Standard Deviation 4.138 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Plasmacytoid dendritic cells: Change at Week 36 | -0.80 cells/mm^3 | Standard Deviation 4.086 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Plasmacytoid dendritic cells: Change at Week 48 | -2.22 cells/mm^3 | Standard Deviation 4.509 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Total dendritic cells: Baseline | 35.4 cells/mm^3 | Standard Deviation 19.92 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Total dendritic cells: Change at Week 4 | 2.0 cells/mm^3 | Standard Deviation 22.35 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Total dendritic cells: Change at Week 8 | -1.3 cells/mm^3 | Standard Deviation 21.68 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Total dendritic cells: Change at Week 12 | -1.9 cells/mm^3 | Standard Deviation 21.07 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Total dendritic cells: Change at Week 24 | 1.6 cells/mm^3 | Standard Deviation 21.89 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Total dendritic cells: Change at Week 36 | 2.5 cells/mm^3 | Standard Deviation 22.19 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Total dendritic cells: Change at Week 48 | -9.1 cells/mm^3 | Standard Deviation 22.77 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Total monocytes [CD14+]: Baseline | 374.6 cells/mm^3 | Standard Deviation 179.05 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Total monocytes [CD14+]: Change at Week 4 | 26.9 cells/mm^3 | Standard Deviation 201.63 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Total monocytes [CD14+]: Change at Week 8 | 12.6 cells/mm^3 | Standard Deviation 189.91 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Total monocytes [CD14+]: Change at Week 12 | 14.4 cells/mm^3 | Standard Deviation 211.67 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Total monocytes [CD14+]: Change at Week 24 | -19.3 cells/mm^3 | Standard Deviation 174.82 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Total monocytes [CD14+]: Change at Week 36 | -21.7 cells/mm^3 | Standard Deviation 186.41 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells | Total monocytes [CD14+]: Change at Week 48 | -19.2 cells/mm^3 | Standard Deviation 175.1 |
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.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | B Cells: Baseline | 235.9 cells per cubic millimeter (cells/mm^3) | Standard Deviation 168.88 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | B Cells: Change at Week 4 | -18.8 cells per cubic millimeter (cells/mm^3) | Standard Deviation 89.71 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | B Cells: Change at Week 8 | -48.2 cells per cubic millimeter (cells/mm^3) | Standard Deviation 122.2 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | B Cells: Change at Week 12 | -65.9 cells per cubic millimeter (cells/mm^3) | Standard Deviation 128.53 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | B Cells: Change at Week 24 | -76.5 cells per cubic millimeter (cells/mm^3) | Standard Deviation 140.33 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | B Cells: Change at Week 36 | -70.1 cells per cubic millimeter (cells/mm^3) | Standard Deviation 104.8 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | B Cells: Change at Week 48 | -60.7 cells per cubic millimeter (cells/mm^3) | Standard Deviation 115.26 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | NK Cells: Baseline | 184.2 cells per cubic millimeter (cells/mm^3) | Standard Deviation 107.12 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | NK Cells: Change at Week 4 | 6.1 cells per cubic millimeter (cells/mm^3) | Standard Deviation 84.66 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | NK Cells: Change at Week 8 | -9.0 cells per cubic millimeter (cells/mm^3) | Standard Deviation 89.55 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | NK Cells: Change at Week 12 | -21.7 cells per cubic millimeter (cells/mm^3) | Standard Deviation 90.82 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | NK Cells: Change at Week 24 | -26.9 cells per cubic millimeter (cells/mm^3) | Standard Deviation 88.06 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | NK Cells: Change at Week 36 | -41.5 cells per cubic millimeter (cells/mm^3) | Standard Deviation 90.37 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | NK Cells: Change at Week 48 | -42.0 cells per cubic millimeter (cells/mm^3) | Standard Deviation 104.88 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | T Cells: Baseline | 1318.1 cells per cubic millimeter (cells/mm^3) | Standard Deviation 544 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | T Cells: Change at Week 4 | -44.8 cells per cubic millimeter (cells/mm^3) | Standard Deviation 383.55 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | T Cells: Change at Week 8 | -167.0 cells per cubic millimeter (cells/mm^3) | Standard Deviation 482.86 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | T Cells: Change at Week 12 | -284.3 cells per cubic millimeter (cells/mm^3) | Standard Deviation 527.58 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | T Cells: Change at Week 24 | -446.7 cells per cubic millimeter (cells/mm^3) | Standard Deviation 542.06 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | T Cells: Change at Week 36 | -545.5 cells per cubic millimeter (cells/mm^3) | Standard Deviation 550.87 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | T Cells: Change at Week 48 | -580.2 cells per cubic millimeter (cells/mm^3) | Standard Deviation 551.52 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | CD4+ T cells: Baseline | 879.0 cells per cubic millimeter (cells/mm^3) | Standard Deviation 400.71 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | CD4+ T cells: Change at Week 4 | -27.4 cells per cubic millimeter (cells/mm^3) | Standard Deviation 256.21 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | CD4+ T cells: Change at Week 8 | -95.4 cells per cubic millimeter (cells/mm^3) | Standard Deviation 318.07 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | CD4+ T cells: Change at Week 12 | -176.8 cells per cubic millimeter (cells/mm^3) | Standard Deviation 353.52 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | CD4+ T cells: Change at Week 24 | -269.8 cells per cubic millimeter (cells/mm^3) | Standard Deviation 360.92 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | CD4+ T cells: Change at Week 36 | -329.7 cells per cubic millimeter (cells/mm^3) | Standard Deviation 374.66 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | CD4+ T cells: Change at Week 48 | -352.6 cells per cubic millimeter (cells/mm^3) | Standard Deviation 380.77 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | CD8+ T cells: Baseline | 419.5 cells per cubic millimeter (cells/mm^3) | Standard Deviation 203.76 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | CD8+ T cells:Change at Week 4 | -14.2 cells per cubic millimeter (cells/mm^3) | Standard Deviation 147.21 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | CD8+ T cells:Change at Week 8 | -65.3 cells per cubic millimeter (cells/mm^3) | Standard Deviation 181.65 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | CD8+ T cells:Change at Week 12 | -100.4 cells per cubic millimeter (cells/mm^3) | Standard Deviation 193.28 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | CD8+ T cells:Change at Week 24 | -170.2 cells per cubic millimeter (cells/mm^3) | Standard Deviation 201.14 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | CD8+ T cells:Change at Week 36 | -201.4 cells per cubic millimeter (cells/mm^3) | Standard Deviation 203.1 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK) | CD8+ T cells:Change at Week 48 | -214.9 cells per cubic millimeter (cells/mm^3) | Standard Deviation 203.62 |
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.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IFNg+ (% of CD4+ T cells): Baseline | 3.340 cells/mm^3 | Standard Deviation 2.7365 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IFNg+ (% of CD4+ T cells): Change at Week 4 | 0.090 cells/mm^3 | Standard Deviation 2.235 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IFNg+ (% of CD4+ T cells): Change at Week 8 | -0.356 cells/mm^3 | Standard Deviation 1.9676 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IFNg+ (% of CD4+ T cells): Change at Week12 | -0.729 cells/mm^3 | Standard Deviation 2.157 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IFNg+ (% of CD4+ T cells): Change at Week24 | -1.134 cells/mm^3 | Standard Deviation 2.4239 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IFNg+ (% of CD4+ T cells): Change at Week36 | -1.511 cells/mm^3 | Standard Deviation 2.5109 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IFNg+ (% of CD4+ T cells): Change at Week48 | -1.222 cells/mm^3 | Standard Deviation 2.3513 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IFNg+ (% of CD8+ T cells): Baseline | 6.166 cells/mm^3 | Standard Deviation 4.6199 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IFNg+ (% of CD8+ T cells): Change at Week 4 | 0.493 cells/mm^3 | Standard Deviation 2.8636 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IFNg+ (% of CD8+ T cells): Change at Week 8 | -0.264 cells/mm^3 | Standard Deviation 3.0735 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IFNg+ (% of CD8+ T cells): Change at Week12 | -1.345 cells/mm^3 | Standard Deviation 3.3647 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IFNg+ (% of CD8+ T cells): Change at Week24 | -1.650 cells/mm^3 | Standard Deviation 2.7202 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IFNg+ (% of CD8+ T cells): Change at Week36 | -1.922 cells/mm^3 | Standard Deviation 4.1425 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IFNg+ (% of CD8+ T cells): Change at Week48 | -1.306 cells/mm^3 | Standard Deviation 4.3931 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IFNg+ (% of memory CD4+ T cells): Baseline | 4.518 cells/mm^3 | Standard Deviation 3.0417 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IFNg+ (% of memory CD4+ T cells): CW 4 | 0.050 cells/mm^3 | Standard Deviation 2.5996 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IFNg+ (% of memory CD4+ T cells): CW 8 | -0.295 cells/mm^3 | Standard Deviation 2.6287 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IFNg+ (% of memory CD4+ T cells): CW 12 | -0.851 cells/mm^3 | Standard Deviation 2.859 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IFNg+ (% of memory CD4+ T cells): CW 24 | -1.019 cells/mm^3 | Standard Deviation 2.812 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IFNg+ (% of memory CD4+ T cells): CW 36 | -1.804 cells/mm^3 | Standard Deviation 2.6448 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IFNg+ (% of memory CD4+ T cells): CW 48 | -1.369 cells/mm^3 | Standard Deviation 3.0958 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IFNg+ (% of memory CD8+ T cells): Baseline | 8.795 cells/mm^3 | Standard Deviation 5.906 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IFNg+ (% of memory CD8+ T cells): CW 4 | 0.360 cells/mm^3 | Standard Deviation 3.6006 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IFNg+ (% of memory CD8+ T cells): CW 8 | -0.285 cells/mm^3 | Standard Deviation 4.2645 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IFNg+ (% of memory CD8+ T cells): CW 12 | -1.543 cells/mm^3 | Standard Deviation 3.7393 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IFNg+ (% of memory CD8+ T cells): CW 24 | -0.964 cells/mm^3 | Standard Deviation 3.6799 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IFNg+ (% of memory CD8+ T cells): CW 36 | -2.035 cells/mm^3 | Standard Deviation 5.3349 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IFNg+ (% of memory CD8+ T cells): CW 48 | -0.497 cells/mm^3 | Standard Deviation 5.3126 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-17A+/IFNg- (% of CD4+ T cells): Baseline | 1.244 cells/mm^3 | Standard Deviation 1.5863 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-17A+/IFNg- (% of CD4+ T cells):Change at Week4 | 0.115 cells/mm^3 | Standard Deviation 1.9918 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-17A+/IFNg- (% of CD4+ T cells):Change at Week8 | 0.131 cells/mm^3 | Standard Deviation 1.9097 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-17A+/IFNg- (% of CD4+ T cells):Change at Week12 | 0.470 cells/mm^3 | Standard Deviation 2.3445 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-17A+/IFNg- (% of CD4+ T cells):Change at Week24 | 0.165 cells/mm^3 | Standard Deviation 2.0104 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-17A+/IFNg- (% of CD4+ T cells):Change at Week36 | 0.419 cells/mm^3 | Standard Deviation 2.5007 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-17A+/IFNg- (% of CD4+ T cells):Change at Week48 | 1.693 cells/mm^3 | Standard Deviation 4.2412 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-17A+/IFNg- (% of CD8+ T cells): Baseline | 0.455 cells/mm^3 | Standard Deviation 0.5309 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-17A+/IFNg- (% of CD8+ T cells):Change at Week4 | 0.239 cells/mm^3 | Standard Deviation 1.3557 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-17A+/IFNg- (% of CD8+ T cells):Change at Week8 | 0.032 cells/mm^3 | Standard Deviation 0.6448 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-17A+/IFNg- (% of CD8+ T cells):Change at Week12 | 0.301 cells/mm^3 | Standard Deviation 0.8912 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-17A+/IFNg- (% of CD8+ T cells):Change at Week24 | 0.289 cells/mm^3 | Standard Deviation 0.8526 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-17A+/IFNg- (% of CD8+ T cells):Change at Week36 | 0.911 cells/mm^3 | Standard Deviation 1.3499 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-17A+/IFNg- (% of CD8+ T cells):Change at Week48 | 1.457 cells/mm^3 | Standard Deviation 2.1499 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-17A+/IFNg- (% of memory CD4+ T cells): Baseline | 1.075 cells/mm^3 | Standard Deviation 1.177 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-17A+/IFNg- (% of memory CD4+T cells): CW 4 | 0.000 cells/mm^3 | Standard Deviation 1.3599 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-17A+/IFNg- (% of memory CD4+T cells): CW 8 | 0.040 cells/mm^3 | Standard Deviation 1.3593 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-17A+/IFNg- (% of memory CD4+T cells): CW 12 | 0.373 cells/mm^3 | Standard Deviation 1.7166 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-17A+/IFNg- (% of memory CD4+T cells): CW 24 | 0.228 cells/mm^3 | Standard Deviation 1.498 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-17A+/IFNg- (% of memory CD4+T cells): CW 36 | 0.333 cells/mm^3 | Standard Deviation 1.8786 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-17A+/IFNg- (% of memory CD4+T cells): CW 48 | 1.255 cells/mm^3 | Standard Deviation 2.9557 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-17A+/IFNg- (% of memory CD8+ T cells): Baseline | 0.155 cells/mm^3 | Standard Deviation 0.2356 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-17A+/IFNg- (% of memory CD8+T cells): CW 4 | 0.113 cells/mm^3 | Standard Deviation 0.6972 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-17A+/IFNg- (% of memory CD8+T cells): CW 8 | 0.027 cells/mm^3 | Standard Deviation 0.3641 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-17A+/IFNg- (% of memory CD8+T cells): CW 12 | 0.064 cells/mm^3 | Standard Deviation 0.3641 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-17A+/IFNg- (% of memory CD8+T cells): CW 24 | 0.254 cells/mm^3 | Standard Deviation 0.8682 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-17A+/IFNg- (% of memory CD8+T cells): CW 36 | 0.270 cells/mm^3 | Standard Deviation 0.6113 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-17A+/IFNg- (% of memory CD8+T cells): CW 48 | 0.680 cells/mm^3 | Standard Deviation 1.2842 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-2+ (% of CD4+ T cells): Baseline | 5.177 cells/mm^3 | Standard Deviation 4.5225 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-2+ (% of CD4+ T cells): Change at Week 4 | 0.062 cells/mm^3 | Standard Deviation 3.4662 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-2+ (% of CD4+ T cells): Change at Week 8 | 0.149 cells/mm^3 | Standard Deviation 4.0713 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-2+ (% of CD4+ T cells): Change at Week 12 | -0.069 cells/mm^3 | Standard Deviation 4.0822 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-2+ (% of CD4+ T cells): Change at Week 24 | -0.448 cells/mm^3 | Standard Deviation 3.628 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-2+ (% of CD4+ T cells): Change at Week 36 | -1.837 cells/mm^3 | Standard Deviation 3.8603 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-2+ (% of CD4+ T cells): Change at Week 48 | -1.840 cells/mm^3 | Standard Deviation 5.0951 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-2+ (% of CD8+ T cells): Baseline | 1.180 cells/mm^3 | Standard Deviation 1.4533 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-2+ (% of CD8+ T cells): Change at Week 4 | -0.081 cells/mm^3 | Standard Deviation 1.2797 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-2+ (% of CD8+ T cells): Change at Week 8 | -0.227 cells/mm^3 | Standard Deviation 1.1579 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-2+ (% of CD8+ T cells): Change at Week 12 | -0.2622 cells/mm^3 | Standard Deviation 1.2601 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-2+ (% of CD8+ T cells): Change at Week 24 | -0.525 cells/mm^3 | Standard Deviation 1.0201 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-2+ (% of CD8+ T cells): Change at Week 36 | -0.547 cells/mm^3 | Standard Deviation 1.2886 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-2+ (% of CD8+ T cells): Change at Week 48 | -0.248 cells/mm^3 | Standard Deviation 1.186 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-2+ (% of memory CD4+ T cells): Baseline | 7.053 cells/mm^3 | Standard Deviation 5.6653 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-2+ (% of memory CD4+ T cells): Change at Week 4 | -0.105 cells/mm^3 | Standard Deviation 4.4131 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-2+ (% of memory CD4+ T cells): Change at Week 8 | 0.056 cells/mm^3 | Standard Deviation 4.6541 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-2+ (% of memory CD4+ T cells): Change at Week12 | 0.012 cells/mm^3 | Standard Deviation 4.9241 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-2+ (% of memory CD4+ T cells): Change at Week24 | 0.015 cells/mm^3 | Standard Deviation 4.6456 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-2+ (% of memory CD4+ T cells): Change at Week36 | -2.140 cells/mm^3 | Standard Deviation 4.7723 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-2+ (% of memory CD4+ T cells): Change at Week48 | -1.946 cells/mm^3 | Standard Deviation 5.6985 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-2+ (% of memory CD8+ T cells): Baseline | 1.879 cells/mm^3 | Standard Deviation 1.7964 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-2+ (% of memory CD8+ T cells): Change at Week 4 | -0.218 cells/mm^3 | Standard Deviation 1.6838 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-2+ (% of memory CD8+ T cells): Change at Week 8 | -0.318 cells/mm^3 | Standard Deviation 1.7272 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-2+ (% of memory CD8+ T cells): Change at Week12 | -0.115 cells/mm^3 | Standard Deviation 1.7354 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-2+ (% of memory CD8+ T cells): Change at Week24 | -0.461 cells/mm^3 | Standard Deviation 1.4512 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-2+ (% of memory CD8+ T cells): Change at Week36 | -0.803 cells/mm^3 | Standard Deviation 1.8525 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-2+ (% of memory CD8+ T cells): Change at Week48 | -0.315 cells/mm^3 | Standard Deviation 2.051 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-4+ (% of CD4+ T cells: Baseline | 1.261 cells/mm^3 | Standard Deviation 1.119 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-4+ (% of CD4+ T cells): Change at Week 4 | -0.150 cells/mm^3 | Standard Deviation 1.0429 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-4+ (% of CD4+ T cells): Change at Week 8 | -0.113 cells/mm^3 | Standard Deviation 1.2168 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-4+ (% of CD4+ T cells): Change at Week12 | -0.370 cells/mm^3 | Standard Deviation 1.0594 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-4+ (% of CD4+ T cells): Change at Week24 | -0.170 cells/mm^3 | Standard Deviation 1.1551 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-4+ (% of CD4+ T cells): Change at Week36 | -0.376 cells/mm^3 | Standard Deviation 1.092 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-4+ (% of CD4+ T cells): Change at Week48 | 0.281 cells/mm^3 | Standard Deviation 4.7206 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-4+ (% of CD8+ T cells): Baseline | 1.107 cells/mm^3 | Standard Deviation 1.2924 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-4+ (% of CD8+ T cells): Change at Week 4 | -0.222 cells/mm^3 | Standard Deviation 1.2163 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-4+ (% of CD8+ T cells): Change at Week 8 | -0.189 cells/mm^3 | Standard Deviation 1.3377 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-4+ (% of CD8+ T cells): Change at Week12 | -0.553 cells/mm^3 | Standard Deviation 1.3754 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-4+ (% of CD8+ T cells): Change at Week24 | -0.032 cells/mm^3 | Standard Deviation 1.317 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-4+ (% of CD8+ T cells): Change at Week36 | -0.195 cells/mm^3 | Standard Deviation 1.3334 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-4+ (% of CD8+ T cells): Change at Week48 | 0.786 cells/mm^3 | Standard Deviation 1.3454 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-4+ (% of memory CD4+ T cells): Baseline | 1.406 cells/mm^3 | Standard Deviation 1.2437 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-4+ (% of memory CD4+ T cells): Change at Week 4 | -0.128 cells/mm^3 | Standard Deviation 1.2649 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-4+ (% of memory CD4+ T cells): Change at Week 8 | -0.141 cells/mm^3 | Standard Deviation 1.4642 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-4+ (% of memory CD4+ T cells): Change at Week12 | -0.412 cells/mm^3 | Standard Deviation 1.3656 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-4+ (% of memory CD4+ T cells): Change at Week24 | -0.136 cells/mm^3 | Standard Deviation 1.3059 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-4+ (% of memory CD4+ T cells): Change at Week36 | -0.266 cells/mm^3 | Standard Deviation 1.4005 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-4+ (% of memory CD4+ T cells): Change at Week48 | 0.325 cells/mm^3 | Standard Deviation 1.7918 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-4+ (% of memory CD8+ T cells): Baseline | 1.376 cells/mm^3 | Standard Deviation 1.8963 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-4+ (% of memory CD8+ T cells): Change at Week 4 | -0.180 cells/mm^3 | Standard Deviation 2.0821 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-4+ (% of memory CD8+ T cells): Change at Week 8 | -0.269 cells/mm^3 | Standard Deviation 1.984 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-4+ (% of memory CD8+ T cells): Change at Week12 | -0.795 cells/mm^3 | Standard Deviation 2.2486 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-4+ (% of memory CD8+ T cells): Change at Week24 | 0.416 cells/mm^3 | Standard Deviation 2.3613 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-4+ (% of memory CD8+ T cells): Change at Week36 | -0.284 cells/mm^3 | Standard Deviation 2.4433 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines | IL-4+ (% of memory CD8+ T cells): Change at Week48 | 1.836 cells/mm^3 | Standard Deviation 2.7709 |
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.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated CD4+ T-cell [CD38+]: Baseline | 632.6 cells/mm^3 | Standard Deviation 305.86 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated CD4+ T-cell [CD38+]: Change at Week 4 | 15.2 cells/mm^3 | Standard Deviation 241.73 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated CD4+ T-cell [CD38+]: Change at Week 8 | -26.5 cells/mm^3 | Standard Deviation 241.47 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated CD4+ T-cell [CD38+]: Change at Week 12 | -53.4 cells/mm^3 | Standard Deviation 246.22 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated CD4+ T-cell [CD38+]: Change at Week 24 | -100.4 cells/mm^3 | Standard Deviation 263.58 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated CD4+ T-cell [CD38+]: Change at Week 36 | -106.8 cells/mm^3 | Standard Deviation 308.03 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated CD4+ T-cell [CD38+]: Change at Week 48 | -125.9 cells/mm^3 | Standard Deviation 273.26 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated CD8+ T-cell ([CD38+HLA-DR+]): Baseline | 22.9 cells/mm^3 | Standard Deviation 25.64 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | ActivatedCD8+T-cell(CD38+HLA-DR+):CW 4 | 3.9 cells/mm^3 | Standard Deviation 21.83 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | ActivatedCD8+T-cell(CD38+HLA-DR+):CW 8 | -2.2 cells/mm^3 | Standard Deviation 24.46 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | ActivatedCD8+T-cell(CD38+HLA-DR+):CW 12 | -3.4 cells/mm^3 | Standard Deviation 23.53 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | ActivatedCD8+T-cell(CD38+HLA-DR+):CW 24 | -5.8 cells/mm^3 | Standard Deviation 24.72 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | ActivatedCD8+T-cell(CD38+HLA-DR+):CW 36 | -7.9 cells/mm^3 | Standard Deviation 27.32 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | ActivatedCD8+T-cell(CD38+HLA-DR+):CW 48 | -7.7 cells/mm^3 | Standard Deviation 24.92 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated CD8+ T-cell [CD38+]: Baseline | 275.4 cells/mm^3 | Standard Deviation 158.04 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated CD8+ T-cell [CD38+]: Change at Week 4 | 18.2 cells/mm^3 | Standard Deviation 118.67 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated CD8+ T-cell [CD38+]: Change at Week 8 | -21.7 cells/mm^3 | Standard Deviation 126.38 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated CD8+ T-cell [CD38+]: Change at Week 12 | -50.8 cells/mm^3 | Standard Deviation 132.08 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated CD8+ T-cell [CD38+]: Change at Week 24 | -91.8 cells/mm^3 | Standard Deviation 142.99 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated CD8+ T-cell [CD38+]: Change at Week 36 | -99.3 cells/mm^3 | Standard Deviation 162.79 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated CD8+ T-cell [CD38+]: Change at Week 48 | -114.3 cells/mm^3 | Standard Deviation 152.39 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated Th1 phenotype: Baseline | 10.4 cells/mm^3 | Standard Deviation 6.52 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated Th1 phenotype: Change at Week 4 | 0.6 cells/mm^3 | Standard Deviation 6.09 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated Th1 phenotype: Change at Week 8 | -1.2 cells/mm^3 | Standard Deviation 6.87 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated Th1 phenotype: Change at Week 12 | -2.1 cells/mm^3 | Standard Deviation 6.63 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated Th1 phenotype: Change at Week 24 | -3.5 cells/mm^3 | Standard Deviation 6.47 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated Th1 phenotype: Change at Week 36 | -3.8 cells/mm^3 | Standard Deviation 6.82 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated Th1 phenotype: Change at Week 48 | -4.0 cells/mm^3 | Standard Deviation 6.5 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated Th17 phenotype: Baseline | 1.1 cells/mm^3 | Standard Deviation 1.33 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated Th17 phenotype: Change at Week 4 | 0.0 cells/mm^3 | Standard Deviation 1.01 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated Th17 phenotype: Change at Week 8 | -0.2 cells/mm^3 | Standard Deviation 1.5 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated Th17 phenotype: Change at Week 12 | 0.0 cells/mm^3 | Standard Deviation 1.36 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated Th17 phenotype: Change at Week 24 | -0.4 cells/mm^3 | Standard Deviation 1.33 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated Th17 phenotype: Change at Week 36 | -0.4 cells/mm^3 | Standard Deviation 0.96 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated Th17 phenotype: Change at Week 48 | -0.3 cells/mm^3 | Standard Deviation 1.06 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated Th2-enriched phenotype: Baseline | 4.8 cells/mm^3 | Standard Deviation 4.83 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated Th2-enriched phenotype: Change at Week 4 | 1.2 cells/mm^3 | Standard Deviation 5.36 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated Th2-enriched phenotype: Change at Week 8 | 0.4 cells/mm^3 | Standard Deviation 6.13 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated Th2-enriched phenotype: CW 12 | 0.5 cells/mm^3 | Standard Deviation 6.54 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated Th2-enriched phenotype: CW 24 | 0.6 cells/mm^3 | Standard Deviation 6.84 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated Th2-enriched phenotype: CW 36 | 0.3 cells/mm^3 | Standard Deviation 6.57 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated Th2-enriched phenotype: CW 48 | 0.2 cells/mm^3 | Standard Deviation 5.14 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated CD4+ T-cell [CD38+HLA-DR+]: Baseline | 17.3 cells/mm^3 | Standard Deviation 12.77 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | ActivatedCD4+ T-cell[CD38+HLA-DR+]:CW 4 | 2.5 cells/mm^3 | Standard Deviation 11.63 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | ActivatedCD4+ T-cell[CD38+HLA-DR+]:CW 8 | -0.3 cells/mm^3 | Standard Deviation 12.81 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | ActivatedCD4+ T-cell[CD38+HLA-DR+]:CW 12 | -1.6 cells/mm^3 | Standard Deviation 12.1 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | ActivatedCD4+ T-cell[CD38+HLA-DR+]:CW 24 | -3.2 cells/mm^3 | Standard Deviation 13.54 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | ActivatedCD4+ T-cell[CD38+HLA-DR+]:CW 36 | -4.1 cells/mm^3 | Standard Deviation 12.07 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | ActivatedCD4+ T-cell[CD38+HLA-DR+]:CW 48 | -4.2 cells/mm^3 | Standard Deviation 11.62 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated CD4+ T-cell [HLA-DR+]: Baseline | 64.6 cells/mm^3 | Standard Deviation 32.45 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated CD4+ T-cell [HLA-DR+]: Change at Week 4 | 1.4 cells/mm^3 | Standard Deviation 27.95 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated CD4+ T-cell [HLA-DR+]: Change at Week 8 | -5.1 cells/mm^3 | Standard Deviation 38.57 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated CD4+ T-cell [HLA-DR+]: Change at Week 12 | -11.7 cells/mm^3 | Standard Deviation 31.71 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated CD4+ T-cell [HLA-DR+]: Change at Week 24 | -26.0 cells/mm^3 | Standard Deviation 30.09 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated CD4+ T-cell [HLA-DR+]: Change at Week 36 | -33.6 cells/mm^3 | Standard Deviation 36.39 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated CD4+ T-cell [HLA-DR+]: Change at Week 48 | -30.1 cells/mm^3 | Standard Deviation 38.57 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated CD8+ T-cell [HLA-DR+]: Baseline | 81.2 cells/mm^3 | Standard Deviation 63.34 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated CD8+ T-cell [HLA-DR+]: Change at Week 4 | 2.5 cells/mm^3 | Standard Deviation 46.91 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated CD8+ T-cell [HLA-DR+]: Change at Week 8 | -5.5 cells/mm^3 | Standard Deviation 67.56 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated CD8+ T-cell [HLA-DR+]: Change at Week 12 | -18.2 cells/mm^3 | Standard Deviation 59.58 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated CD8+ T-cell [HLA-DR+]: Change at Week 24 | -38.1 cells/mm^3 | Standard Deviation 57.42 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated CD8+ T-cell [HLA-DR+]: Change at Week 36 | -48.3 cells/mm^3 | Standard Deviation 63.85 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Activated CD8+ T-cell [HLA-DR+]: Change at Week 48 | -49.3 cells/mm^3 | Standard Deviation 59.85 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | CM CD4+ T-cell [CD45RA-CCR7+]: Baseline | 433.4 cells/mm^3 | Standard Deviation 220.05 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | CM CD4+ T-cell[CD45RA-CCR7+]:CW 4 | -21.0 cells/mm^3 | Standard Deviation 185.07 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | CM CD4+ T-cell[CD45RA-CCR7+]:CW 8 | -68.0 cells/mm^3 | Standard Deviation 196.02 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | CM CD4+T-cell[CD45RA-CCR7+]:CW 12 | -105.3 cells/mm^3 | Standard Deviation 206.11 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | CM CD4+T-cell[CD45RA-CCR7+]:CW 24 | -204.2 cells/mm^3 | Standard Deviation 220.61 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | CentralMemoryCD4+T-cell[CD45RA-CCR7+]:CW 36 | -235.7 cells/mm^3 | Standard Deviation 221.44 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | CM CD4+T-cell[CD45RA-CCR7+]:CW 48 | -231.1 cells/mm^3 | Standard Deviation 225.25 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | CM CD8+ T-cell [CD45RA-CCR7+]: Baseline | 59.9 cells/mm^3 | Standard Deviation 60.38 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | CM CD8+T-cell[CD45RA-CCR7+]:CW 4 | -9.6 cells/mm^3 | Standard Deviation 45.92 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | CM CD8+T-cell[CD45RA-CCR7+]:CW 8 | -16.9 cells/mm^3 | Standard Deviation 41.72 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | CM CD8+T-cell[CD45RA-CCR7+]:CW 12 | -22.0 cells/mm^3 | Standard Deviation 48.1 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | CM CD8+T-cell[CD45RA-CCR7+]:CW 24 | -39.2 cells/mm^3 | Standard Deviation 50 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | CM CD8+T-cell[CD45RA-CCR7+]:CW 36 | -44.3 cells/mm^3 | Standard Deviation 55.66 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | CM CD8+T-cell[CD45RA-CCR7+]:CW 48 | -45.9 cells/mm^3 | Standard Deviation 53.78 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Effector CD4+ T-cell [CD45RA+CCR7-]: Baseline | 12.0 cells/mm^3 | Standard Deviation 23.21 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Effector CD4+ T-cell[CD45RA+CCR7-]:Change atWeek4 | 0.8 cells/mm^3 | Standard Deviation 12.66 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Effector CD4+ T-cell[CD45RA+CCR7-]:Change atWeek8 | -0.1 cells/mm^3 | Standard Deviation 12.58 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Effector CD4+ T-cell[CD45RA+CCR7-]:Change atWeek12 | -1.0 cells/mm^3 | Standard Deviation 12.43 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Effector CD4+ T-cell[CD45RA+CCR7-]:CW 24 | -1.6 cells/mm^3 | Standard Deviation 17.42 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Effector CD4+ T-cell[CD45RA+CCR7-]:CW 36 | -1.9 cells/mm^3 | Standard Deviation 19.2 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Effector CD4+ T-cell[CD45RA+CCR7-]:CW 48 | -4.7 cells/mm^3 | Standard Deviation 18.75 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Effector CD8+ T-cell [CD45RA+CCR7-]: Baseline | 101.4 cells/mm^3 | Standard Deviation 91.95 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Effector CD8+ T-cell[CD45RA+CCR7-]:Change atWeek4 | 1.7 cells/mm^3 | Standard Deviation 63.49 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Effector CD8+ T-cell[CD45RA+CCR7-]:Change atWeek8 | -15.9 cells/mm^3 | Standard Deviation 67.93 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Effector CD8+ T-cell[CD45RA+CCR7-]:CW 12 | -15.2 cells/mm^3 | Standard Deviation 80.78 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Effector CD8+ T-cell[CD45RA+CCR7-]:CW 24 | -42.8 cells/mm^3 | Standard Deviation 74.14 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Effector CD8+ T-cell[CD45RA+CCR7-]:CW 36 | -55.6 cells/mm^3 | Standard Deviation 78.88 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Effector CD8+ T-cell[CD45RA+CCR7-]:CW 48 | -50.9 cells/mm^3 | Standard Deviation 82.46 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | EM CD4+ T-cell [CD45RA-CCR7-]: Baseline | 179.7 cells/mm^3 | Standard Deviation 86.21 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | EM CD4+ T-cell [CD45RA-CCR7-]: Change at Week 4 | 10.9 cells/mm^3 | Standard Deviation 87.56 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | EM CD4+ T-cell [CD45RA-CCR7-]: Change at Week 8 | -33.2 cells/mm^3 | Standard Deviation 88.53 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | EM CD4+ T-cell [CD45RA-CCR7-]: Change at Week 12 | -55.2 cells/mm^3 | Standard Deviation 90.59 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | EM CD4+ T-cell [CD45RA-CCR7-]: Change at Week 24 | -81.7 cells/mm^3 | Standard Deviation 106.78 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | EM CD4+ T-cell [CD45RA-CCR7-]: Change at Week 36 | -98.1 cells/mm^3 | Standard Deviation 111.77 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | EM CD4+ T-cell [CD45RA-CCR7-]: Change at Week 48 | -118.5 cells/mm^3 | Standard Deviation 100.25 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | EM CD8+ T-cell [CD45RA-CCR7-]: Baseline | 129.0 cells/mm^3 | Standard Deviation 92.24 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | EM CD8+ T-cell [CD45RA-CCR7-]: Change at Week 4 | 7.6 cells/mm^3 | Standard Deviation 82.42 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | EM CD8+ T-cell [CD45RA-CCR7-]: Change at Week 8 | -22.8 cells/mm^3 | Standard Deviation 88.05 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | EM CD8+ T-cell [CD45RA-CCR7-]: Change at Week 12 | -41.0 cells/mm^3 | Standard Deviation 85.82 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | EM CD8+ T-cell [CD45RA-CCR7-]: Change at Week 24 | -69.9 cells/mm^3 | Standard Deviation 90.17 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | EM CD8+ T-cell [CD45RA-CCR7-]: Change at Week 36 | -80.3 cells/mm^3 | Standard Deviation 96.19 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | EM CD8+ T-cell [CD45RA-CCR7-]: Change at Week 48 | -90.3 cells/mm^3 | Standard Deviation 97.07 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Effector Regulatory T-cells: Baseline | 56.1 cells/mm^3 | Standard Deviation 28.88 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Effector Regulatory T-cells: Change at Week 4 | 0.6 cells/mm^3 | Standard Deviation 26.13 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Effector Regulatory T-cells: Change at Week 8 | -7.1 cells/mm^3 | Standard Deviation 27.32 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Effector Regulatory T-cells: Change at Week 12 | -12.7 cells/mm^3 | Standard Deviation 25.81 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Effector Regulatory T-cells: Change at Week 24 | -20.3 cells/mm^3 | Standard Deviation 28.31 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Effector Regulatory T-cells: Change at Week 36 | -25.8 cells/mm^3 | Standard Deviation 31.5 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Effector Regulatory T-cells: Change at Week 48 | -25.1 cells/mm^3 | Standard Deviation 29.73 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Memory CD4+ T-cell [CD45RA-]: Baseline | 617.7 cells/mm^3 | Standard Deviation 256.07 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Memory CD4+ T-cell [CD45RA-]: Change at Week 4 | -6.2 cells/mm^3 | Standard Deviation 233.54 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Memory CD4+ T-cell [CD45RA-]: Change at Week 8 | -100.9 cells/mm^3 | Standard Deviation 252.99 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Memory CD4+ T-cell [CD45RA-]: Change at Week 12 | -157.7 cells/mm^3 | Standard Deviation 269.36 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Memory CD4+ T-cell [CD45RA-]: Change at Week 24 | -287.7 cells/mm^3 | Standard Deviation 291.97 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Memory CD4+ T-cell [CD45RA-]: Change at Week 36 | -335.0 cells/mm^3 | Standard Deviation 299.23 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Memory CD4+ T-cell [CD45RA-]: Change at Week 48 | -349.9 cells/mm^3 | Standard Deviation 289.24 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Memory CD8+ T-cell [CD45RA-]: Baseline | 187.5 cells/mm^3 | Standard Deviation 126.58 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Memory CD8+ T-cell [CD45RA-]: Change at Week 4 | -4.7 cells/mm^3 | Standard Deviation 97.59 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Memory CD8+ T-cell [CD45RA-]: Change at Week 8 | -40.9 cells/mm^3 | Standard Deviation 109.49 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Memory CD8+ T-cell [CD45RA-]: Change at Week 12 | -64.0 cells/mm^3 | Standard Deviation 118.89 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Memory CD8+ T-cell [CD45RA-]: Change at Week 24 | -108.6 cells/mm^3 | Standard Deviation 119.94 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Memory CD8+ T-cell [CD45RA-]: Change at Week 36 | -124.9 cells/mm^3 | Standard Deviation 126.3 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Memory CD8+ T-cell [CD45RA-]: Change at Week 48 | -136.3 cells/mm^3 | Standard Deviation 129.68 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve CD4+ T-cell [CD45RA+CCR7+]: Baseline | 400.9 cells/mm^3 | Standard Deviation 261.16 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve CD4+ T-cell [CD45RA+CCR7+]: Change at Week 4 | -10.5 cells/mm^3 | Standard Deviation 175.86 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve CD4+ T-cell [CD45RA+CCR7+]: Change at Week 8 | -16.4 cells/mm^3 | Standard Deviation 169.6 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve CD4+ T-cell[CD45RA+CCR7+]:Change at Week 12 | -11.8 cells/mm^3 | Standard Deviation 177.35 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve CD4+ T-cell[CD45RA+CCR7+]:Change at Week 24 | -31.7 cells/mm^3 | Standard Deviation 190.17 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve CD4+ T-cell[CD45RA+CCR7+]:Change at Week 36 | -29.3 cells/mm^3 | Standard Deviation 204.15 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve CD4+ T-cell[CD45RA+CCR7+]:Change at Week 48 | -34.4 cells/mm^3 | Standard Deviation 197.57 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve CD4+ T-cell [CD45RA+]: Baseline | 416.7 cells/mm^3 | Standard Deviation 268.35 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve CD4+ T-cell [CD45RA+]: Change at Week 4 | -8.6 cells/mm^3 | Standard Deviation 177.59 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve CD4+ T-cell [CD45RA+]: Change at Week 8 | -15.6 cells/mm^3 | Standard Deviation 173.25 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve CD4+ T-cell [CD45RA+]: Change at Week 12 | -10.2 cells/mm^3 | Standard Deviation 185.67 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve CD4+ T-cell [CD45RA+]: Change at Week 24 | -33.6 cells/mm^3 | Standard Deviation 193.78 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve CD4+ T-cell [CD45RA+]: Change at Week 36 | -30.2 cells/mm^3 | Standard Deviation 214.46 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve CD4+ T-cell [CD45RA+]: Change at Week 48 | -37.0 cells/mm^3 | Standard Deviation 206.1 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve CD8+ T-cell [CD45RA+CCR7+]: Baseline | 160.1 cells/mm^3 | Standard Deviation 108.32 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve CD8+ T-cell [CD45RA+CCR7+]: Change at Week 4 | -11.6 cells/mm^3 | Standard Deviation 79.05 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve CD8+ T-cell [CD45RA+CCR7+]: Change at Week 8 | -12.4 cells/mm^3 | Standard Deviation 75.66 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve CD8+ T-cell[CD45RA+CCR7+]:Change at Week 12 | -22.0 cells/mm^3 | Standard Deviation 73.23 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve CD8+ T-cell[CD45RA+CCR7+]:Change at Week 24 | -41.3 cells/mm^3 | Standard Deviation 77.22 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve CD8+ T-cell[CD45RA+CCR7+]:Change at Week 36 | -49.0 cells/mm^3 | Standard Deviation 88.78 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve CD8+ T-cell[CD45RA+CCR7+]:Change at Week 48 | -50.9 cells/mm^3 | Standard Deviation 80.43 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve CD8+ T-cell [CD45RA+]: Baseline | 258.0 cells/mm^3 | Standard Deviation 150.73 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve CD8+ T-cell [CD45RA+]: Change at Week 4 | -11.7 cells/mm^3 | Standard Deviation 118.68 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve CD8+ T-cell [CD45RA+]: Change at Week 8 | -28.3 cells/mm^3 | Standard Deviation 118.33 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve CD8+ T-cell [CD45RA+]: Change at Week 12 | -39.7 cells/mm^3 | Standard Deviation 131.27 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve CD8+ T-cell [CD45RA+]: Change at Week 24 | -82.4 cells/mm^3 | Standard Deviation 134 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve CD8+ T-cell [CD45RA+]: Change at Week 36 | -106.1 cells/mm^3 | Standard Deviation 139.47 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve CD8+ T-cell [CD45RA+]: Change at Week 48 | -103.4 cells/mm^3 | Standard Deviation 138.84 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve Regulatory T-cells: Baseline | 15.8 cells/mm^3 | Standard Deviation 13.44 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve Regulatory T-cells: Change at Week 4 | -0.1 cells/mm^3 | Standard Deviation 11.9 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve Regulatory T-cells: Change at Week 8 | -0.4 cells/mm^3 | Standard Deviation 12.19 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve Regulatory T-cells: Change at Week 12 | -0.7 cells/mm^3 | Standard Deviation 9.84 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve Regulatory T-cells: Change at Week 24 | -0.4 cells/mm^3 | Standard Deviation 11.87 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve Regulatory T-cells: Change at Week 36 | 0.1 cells/mm^3 | Standard Deviation 12.07 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Naïve Regulatory T-cells: Change at Week 48 | -0.1 cells/mm^3 | Standard Deviation 10.25 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Regulatory T-cells: Baseline | 71.5 cells/mm^3 | Standard Deviation 36.6 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Regulatory T-cells: Change at Week 4 | 1.0 cells/mm^3 | Standard Deviation 34.31 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Regulatory T-cells: Change at Week 8 | -7.3 cells/mm^3 | Standard Deviation 35.01 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Regulatory T-cells: Change at Week 12 | -13.3 cells/mm^3 | Standard Deviation 32.12 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Regulatory T-cells: Change at Week 24 | -20.0 cells/mm^3 | Standard Deviation 36.77 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Regulatory T-cells: Change at Week 36 | -25.7 cells/mm^3 | Standard Deviation 40.18 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Regulatory T-cells: Change at Week 48 | -24.4 cells/mm^3 | Standard Deviation 36.09 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Terminal Effector Regulatory T-cells: Baseline | 327.2 cells/mm^3 | Standard Deviation 168.48 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Terminal Effector Regulatory T-cells: CW 4 | 16.6 cells/mm^3 | Standard Deviation 158.45 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Terminal Effector Regulatory T-cells: CW 8 | -4.4 cells/mm^3 | Standard Deviation 167.36 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Terminal Effector Regulatory T-cells: CW 12 | -17.6 cells/mm^3 | Standard Deviation 167.8 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Terminal Effector Regulatory T-cells: CW 24 | -58.3 cells/mm^3 | Standard Deviation 174.97 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Terminal Effector Regulatory T-cells: CW 36 | -97.2 cells/mm^3 | Standard Deviation 199.08 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Terminal Effector Regulatory T-cells: CW 48 | -98.6 cells/mm^3 | Standard Deviation 186.01 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Th1 phenotype: Baseline | 329.5 cells/mm^3 | Standard Deviation 153.17 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Th1 phenotype: Change at Week 4 | -14.7 cells/mm^3 | Standard Deviation 127.21 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Th1 phenotype: Change at Week 8 | -65.4 cells/mm^3 | Standard Deviation 147.25 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Th1 phenotype: Change at Week 12 | -102.1 cells/mm^3 | Standard Deviation 149.63 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Th1 phenotype: Change at Week 24 | -159.2 cells/mm^3 | Standard Deviation 172.24 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Th1 phenotype: Change at Week 36 | -183.0 cells/mm^3 | Standard Deviation 177.4 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Th1 phenotype: Change at Week 48 | -187.4 cells/mm^3 | Standard Deviation 172.19 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Th17 phenotype: Baseline | 61.9 cells/mm^3 | Standard Deviation 40.76 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Th17 phenotype: Change at Week 4 | -0.5 cells/mm^3 | Standard Deviation 37.46 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Th17 phenotype: Change at Week 8 | -7.3 cells/mm^3 | Standard Deviation 39.1 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Th17 phenotype: Change at Week 12 | -1.1 cells/mm^3 | Standard Deviation 45.74 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Th17 phenotype: Change at Week 24 | -24.6 cells/mm^3 | Standard Deviation 42.79 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Th17 phenotype: Change at Week 36 | -35.1 cells/mm^3 | Standard Deviation 39.56 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Th17 phenotype: Change at Week 48 | -30.1 cells/mm^3 | Standard Deviation 39.12 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Th2-enriched phenotype: Baseline | 562.7 cells/mm^3 | Standard Deviation 289.42 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Th2-enriched phenotype: Change at Week 4 | -0.6 cells/mm^3 | Standard Deviation 211.18 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Th2-enriched phenotype: Change at Week 8 | -31.5 cells/mm^3 | Standard Deviation 227.69 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Th2-enriched phenotype: Change at Week 12 | -54.0 cells/mm^3 | Standard Deviation 210.95 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Th2-enriched phenotype: Change at Week 24 | -96.7 cells/mm^3 | Standard Deviation 241.83 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Th2-enriched phenotype: Change at Week 36 | -97.7 cells/mm^3 | Standard Deviation 267.45 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets | Th2-enriched phenotype: Change at Week 48 | -125.2 cells/mm^3 | Standard Deviation 242.46 |
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).
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of B cells): Baseline | 99.33 cells/mm^3 | Standard Deviation 2.106 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of B cells): Change at Week 4 | 0.34 cells/mm^3 | Standard Deviation 2.497 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of B cells): Change at Week 8 | 0.44 cells/mm^3 | Standard Deviation 2.203 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of B cells): Change at Week 12 | 0.17 cells/mm^3 | Standard Deviation 2.534 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of B cells): Change at Week 24 | 0.19 cells/mm^3 | Standard Deviation 2.549 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of B cells): Change at Week 36 | -1.43 cells/mm^3 | Standard Deviation 11.406 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of B cells): Change at Week 48 | -0.14 cells/mm^3 | Standard Deviation 7.751 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of T cells): Baseline | 99.90 cells/mm^3 | Standard Deviation 0.312 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of T cells): Change at Week 4 | 0.05 cells/mm^3 | Standard Deviation 0.319 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of T cells): Change at Week 8 | 0.07 cells/mm^3 | Standard Deviation 0.327 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of T cells): Change at Week 12 | 0.06 cells/mm^3 | Standard Deviation 0.321 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of T cells): Change at Week 24 | 0.02 cells/mm^3 | Standard Deviation 0.633 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of T cells): Change at Week 36 | -1.29 cells/mm^3 | Standard Deviation 9.76 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of T cells): Change at Week 48 | -0.53 cells/mm^3 | Standard Deviation 7.41 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of MNC): Baseline | 96.85 cells/mm^3 | Standard Deviation 3.089 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of MNC): Change at Week 4 | 0.47 cells/mm^3 | Standard Deviation 3.63 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of MNC): Change at Week 8 | 0.59 cells/mm^3 | Standard Deviation 3.532 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of MNC): Change at Week 12 | 0.59 cells/mm^3 | Standard Deviation 3.71 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of MNC): Change at Week 24 | -0.38 cells/mm^3 | Standard Deviation 3.963 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of MNC): Change at Week 36 | -1.55 cells/mm^3 | Standard Deviation 10.918 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of MNC): Change at Week 48 | -2.31 cells/mm^3 | Standard Deviation 8.402 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of dendritic cells [CD11c++]): Baseline | 99.81 cells/mm^3 | Standard Deviation 0.933 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of dendritic cells [CD11c++]): CW 4 | 0.04 cells/mm^3 | Standard Deviation 0.867 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of dendritic cells [CD11c++]): CW 8 | 0.02 cells/mm^3 | Standard Deviation 1.573 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of dendritic cells [CD11c++]): CW 12 | 0.10 cells/mm^3 | Standard Deviation 1.25 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of dendritic cells [CD11c++]): CW 24 | 0.01 cells/mm^3 | Standard Deviation 1.477 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of dendritic cells [CD11c++]): CW 36 | -1.27 cells/mm^3 | Standard Deviation 10.857 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of dendritic cells [CD11c++]): CW 48 | -0.84 cells/mm^3 | Standard Deviation 7.813 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of lymphocytes): Baseline | 98.24 cells/mm^3 | Standard Deviation 1.87 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of lymphocytes): Change at Week 4 | 0.04 cells/mm^3 | Standard Deviation 2.227 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of lymphocytes): Change at Week 8 | 0.07 cells/mm^3 | Standard Deviation 2.649 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of lymphocytes): Change at Week 12 | 0.26 cells/mm^3 | Standard Deviation 2.604 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of lymphocytes): Change at Week 24 | -0.35 cells/mm^3 | Standard Deviation 2.519 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of lymphocytes): Change at Week 36 | -1.99 cells/mm^3 | Standard Deviation 10.532 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of lymphocytes): Change at Week 48 | -2.56 cells/mm^3 | Standard Deviation 8.696 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of monocytes): Baseline | 98.00 cells/mm^3 | Standard Deviation 2.303 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of monocytes): Change at Week 4 | 0.29 cells/mm^3 | Standard Deviation 3.241 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of monocytes): Change at Week 8 | 0.92 cells/mm^3 | Standard Deviation 2.416 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of monocytes): Change at Week 12 | 0.77 cells/mm^3 | Standard Deviation 2.539 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of monocytes): Change at Week 24 | -0.40 cells/mm^3 | Standard Deviation 3.046 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of monocytes): Change at Week 36 | -0.36 cells/mm^3 | Standard Deviation 7.843 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of monocytes): Change at Week 48 | -1.52 cells/mm^3 | Standard Deviation 7.711 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of neutrophils): Baseline | 97.80 cells/mm^3 | Standard Deviation 5.352 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of neutrophils): Change at Week 4 | 0.83 cells/mm^3 | Standard Deviation 6.672 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of neutrophils): Change at Week 8 | 1.23 cells/mm^3 | Standard Deviation 5.675 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of neutrophils): Change at Week 12 | 0.55 cells/mm^3 | Standard Deviation 6.113 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of neutrophils): Change at Week 24 | 0.35 cells/mm^3 | Standard Deviation 9.22 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of neutrophils): Change at Week 36 | -2.88 cells/mm^3 | Standard Deviation 18.513 |
| Dimethyl Fumarate (BG00012) | 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 | CD11a+ (% of neutrophils): Change at Week 48 | 0.42 cells/mm^3 | Standard Deviation 10.736 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of B cells): Baseline | 99.87 cells/mm^3 | Standard Deviation 0.679 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of B cells): Change at Week 4 | -0.50 cells/mm^3 | Standard Deviation 7.105 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of B cells): Change at Week 8 | 0.00 cells/mm^3 | Standard Deviation 0.642 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of B cells): Change at Week 12 | 0.01 cells/mm^3 | Standard Deviation 0.486 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of B cells): Change at Week 24 | -0.01 cells/mm^3 | Standard Deviation 0.663 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of B cells): Change at Week 36 | -0.07 cells/mm^3 | Standard Deviation 0.744 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of B cells): Change at Week 48 | -0.04 cells/mm^3 | Standard Deviation 0.964 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of T cells): Baseline | 91.23 cells/mm^3 | Standard Deviation 4.427 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of T cells): Change at Week 4 | -0.45 cells/mm^3 | Standard Deviation 6.909 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of T cells): Change at Week 8 | -0.11 cells/mm^3 | Standard Deviation 2.055 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of T cells): Change at Week 12 | -0.06 cells/mm^3 | Standard Deviation 1.93 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of T cells): Change at Week 24 | -0.12 cells/mm^3 | Standard Deviation 2.209 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of T cells): Change at Week 36 | -1.32 cells/mm^3 | Standard Deviation 4.256 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of T cells): Change at Week 48 | -0.02 cells/mm^3 | Standard Deviation 2.935 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of MNC): Baseline | 86.79 cells/mm^3 | Standard Deviation 5.369 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of MNC): Change at Week 4 | 0.23 cells/mm^3 | Standard Deviation 8.274 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of MNC): Change at Week 8 | 0.38 cells/mm^3 | Standard Deviation 5.6 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of MNC): Change at Week 12 | 0.85 cells/mm^3 | Standard Deviation 5.9 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of MNC): Change at Week 24 | -0.07 cells/mm^3 | Standard Deviation 6.051 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of MNC): Change at Week 36 | -0.46 cells/mm^3 | Standard Deviation 8.264 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of MNC): Change at Week 48 | -1.25 cells/mm^3 | Standard Deviation 6.561 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of dendritic cells [CD11c++]): Baseline | 99.77 cells/mm^3 | Standard Deviation 0.771 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of dendritic cells [CD11c++]): CW 4 | -0.42 cells/mm^3 | Standard Deviation 7.185 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of dendritic cells [CD11c++]): CW 8 | 0.12 cells/mm^3 | Standard Deviation 0.874 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of dendritic cells [CD11c++]): CW 12 | 0.03 cells/mm^3 | Standard Deviation 1.252 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of dendritic cells [CD11c++]): CW 24 | 0.00 cells/mm^3 | Standard Deviation 1.162 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of dendritic cells [CD11c++]): CW 36 | -0.06 cells/mm^3 | Standard Deviation 1.532 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of dendritic cells [CD11c++]): CW 48 | -0.23 cells/mm^3 | Standard Deviation 1.53 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of lymphocytes): Baseline | 91.29 cells/mm^3 | Standard Deviation 4.715 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of lymphocytes): Change at Week 4 | -0.31 cells/mm^3 | Standard Deviation 7.26 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of lymphocytes): Change at Week 8 | 0.03 cells/mm^3 | Standard Deviation 5.899 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of lymphocytes): Change at Week 12 | 0.44 cells/mm^3 | Standard Deviation 2.989 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of lymphocytes): Change at Week 24 | 0.01 cells/mm^3 | Standard Deviation 3.237 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of lymphocytes): Change at Week 36 | -0.75 cells/mm^3 | Standard Deviation 5.045 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of lymphocytes): Change at Week 48 | -1.10 cells/mm^3 | Standard Deviation 5.739 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of monocytes): Baseline | 88.77 cells/mm^3 | Standard Deviation 8.126 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of monocytes): Change at Week 4 | 0.82 cells/mm^3 | Standard Deviation 10.895 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of monocytes): Change at Week 8 | 0.96 cells/mm^3 | Standard Deviation 10.161 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of monocytes): Change at Week 12 | 0.82 cells/mm^3 | Standard Deviation 10.35 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of monocytes): Change at Week 24 | 0.98 cells/mm^3 | Standard Deviation 9.793 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of monocytes): Change at Week 36 | 3.87 cells/mm^3 | Standard Deviation 9.683 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of monocytes): Change at Week 48 | 0.69 cells/mm^3 | Standard Deviation 10.594 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of neutrophils): Baseline | 5.61 cells/mm^3 | Standard Deviation 7.277 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of neutrophils): Change at Week 4 | 4.43 cells/mm^3 | Standard Deviation 9.345 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of neutrophils): Change at Week 8 | 1.17 cells/mm^3 | Standard Deviation 4.892 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of neutrophils): Change at Week 12 | 0.27 cells/mm^3 | Standard Deviation 4.137 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of neutrophils): Change at Week 24 | -0.67 cells/mm^3 | Standard Deviation 10.365 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of neutrophils): Change at Week 36 | -0.29 cells/mm^3 | Standard Deviation 12.678 |
| Dimethyl Fumarate (BG00012) | 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 | CD49d+ (% of neutrophils): Change at Week 48 | 0.92 cells/mm^3 | Standard Deviation 10.291 |
Secondary
Change From Baseline in Immunoglobulin A (IgA) up to 48 Weeks
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin A (IgA) up to 48 Weeks | Baseline | 2116.5 milligram per liter (mg/L) | Standard Deviation 910.47 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin A (IgA) up to 48 Weeks | Change at Week 4 | -120.0 milligram per liter (mg/L) | Standard Deviation 231.16 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin A (IgA) up to 48 Weeks | Change at Week 8 | -112.8 milligram per liter (mg/L) | Standard Deviation 243.28 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin A (IgA) up to 48 Weeks | Change at Week 12 | -93.6 milligram per liter (mg/L) | Standard Deviation 291.76 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin A (IgA) up to 48 Weeks | Change at Week 24 | -101.5 milligram per liter (mg/L) | Standard Deviation 324.27 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin A (IgA) up to 48 Weeks | Change at Week 36 | -65.1 milligram per liter (mg/L) | Standard Deviation 279.53 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin A (IgA) up to 48 Weeks | Change at Week 48 | -94.9 milligram per liter (mg/L) | Standard Deviation 291.25 |
Secondary
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclass 2: Baseline | 350.7 milligram per deciliter | Standard Deviation 116.43 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclasses 1-4 Quant: Change at Week 36 | -70.3 milligram per deciliter | Standard Deviation 103.59 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclasses 1-4 Quant: Change at Week 48 | -65.1 milligram per deciliter | Standard Deviation 130.94 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclass 1: Baseline | 542.9 milligram per deciliter | Standard Deviation 152.87 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclass 1: Change at Week 4 | -29.2 milligram per deciliter | Standard Deviation 68.22 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclass 1: Change at Week 8 | -28.5 milligram per deciliter | Standard Deviation 71.46 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclass 1: Change at Week 12 | -14.8 milligram per deciliter | Standard Deviation 79.07 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclass 1: Change at Week 24 | -3.0 milligram per deciliter | Standard Deviation 78.8 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclass 1: Change at Week 36 | -23.1 milligram per deciliter | Standard Deviation 61.73 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclass 1: Change at Week 48 | -0.5 milligram per deciliter | Standard Deviation 102.41 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclass 2: Change at Week 4 | -22.7 milligram per deciliter | Standard Deviation 47.42 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclass 2: Change at Week 8 | -26.5 milligram per deciliter | Standard Deviation 48.98 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclass 2: Change at Week 12 | -18.9 milligram per deciliter | Standard Deviation 44.11 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclass 2: Change at Week 24 | -5.5 milligram per deciliter | Standard Deviation 54.39 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclass 2: Change at Week 36 | -22.4 milligram per deciliter | Standard Deviation 45.49 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclass 2: Change at Week 48 | -21.5 milligram per deciliter | Standard Deviation 50.98 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclass 3: Baseline | 56.93 milligram per deciliter | Standard Deviation 26.86 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclass 3: Change at Week 4 | -2.1 milligram per deciliter | Standard Deviation 8.56 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclass 3: Change at Week 8 | -0.7 milligram per deciliter | Standard Deviation 12.36 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclass 3: Change at Week 12 | -1.0 milligram per deciliter | Standard Deviation 15.48 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclass 3: Change at Week 24 | -0.4 milligram per deciliter | Standard Deviation 11.31 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclass 3: Change at Week 36 | 4.6 milligram per deciliter | Standard Deviation 19.09 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclass 3: Change at Week 48 | 1.5 milligram per deciliter | Standard Deviation 12.55 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclass 4: Baseline | 30.35 milligram per deciliter | Standard Deviation 29.681 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclass 4: Change at Week 4 | 1.24 milligram per deciliter | Standard Deviation 9.242 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclass 4: Change at Week 8 | -0.38 milligram per deciliter | Standard Deviation 10.995 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclass 4: Change at Week 12 | -0.12 milligram per deciliter | Standard Deviation 11.711 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclass 4: Change at Week 24 | 1.08 milligram per deciliter | Standard Deviation 15.253 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclass 4: Change at Week 36 | 1.28 milligram per deciliter | Standard Deviation 12.236 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclass 4: Change at Week 48 | 3.26 milligram per deciliter | Standard Deviation 10.962 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclasses 1-4 Quant: Baseline | 1029.9 milligram per deciliter | Standard Deviation 232.33 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclasses 1-4 Quant: Change at Week 4 | -54.6 milligram per deciliter | Standard Deviation 101.48 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclasses 1-4 Quant: Change at Week 8 | -41.9 milligram per deciliter | Standard Deviation 100.16 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclasses 1-4 Quant: Change at Week 12 | -28.5 milligram per deciliter | Standard Deviation 114.3 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks | IgG Subclasses 1-4 Quant: Change at Week 24 | -55.7 milligram per deciliter | Standard Deviation 116.69 |
Secondary
Change From Baseline in Immunoglobulin G (IgG) up to 48 Weeks
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) up to 48 Weeks | Change at Week 36 | -0.36 g/L | Standard Deviation 1.025 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) up to 48 Weeks | Change at Week 48 | -0.53 g/L | Standard Deviation 1.142 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) up to 48 Weeks | Baseline | 10.51 g/L | Standard Deviation 2.328 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) up to 48 Weeks | Change at Week 4 | -0.77 g/L | Standard Deviation 1.039 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) up to 48 Weeks | Change at Week 8 | -0.64 g/L | Standard Deviation 1.077 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) up to 48 Weeks | Change at Week 12 | -0.44 g/L | Standard Deviation 1.187 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin G (IgG) up to 48 Weeks | Change at Week 24 | -0.62 g/L | Standard Deviation 1.324 |
Secondary
Change From Baseline in Immunoglobulin M (IgM) up to 48 Weeks
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin M (IgM) up to 48 Weeks | Baseline | 1330.1 mg/L | Standard Deviation 705.92 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin M (IgM) up to 48 Weeks | Change at Week 4 | -68.9 mg/L | Standard Deviation 214.07 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin M (IgM) up to 48 Weeks | Change at Week 8 | -23.2 mg/L | Standard Deviation 208.48 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin M (IgM) up to 48 Weeks | Change at Week 12 | -18.8 mg/L | Standard Deviation 270.82 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin M (IgM) up to 48 Weeks | Change at Week 24 | -36.9 mg/L | Standard Deviation 293.14 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin M (IgM) up to 48 Weeks | Change at Week 36 | -19.4 mg/L | Standard Deviation 406.86 |
| Dimethyl Fumarate (BG00012) | Change From Baseline in Immunoglobulin M (IgM) up to 48 Weeks | Change at Week 48 | -96.8 mg/L | Standard Deviation 236.48 |