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CompletedNCT02525874Updated Jun 27, 2019Results posted

Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).

A Phase 3 interventional study of dimethyl fumarate in Multiple Sclerosis, Relapsing-Remitting and Multiple Sclerosis, sponsored by Biogen. Completed at 34 sites in 7 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-06-27.

Sponsored by Biogen · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
218
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Multiple Sclerosis, Relapsing-Remitting
  • Multiple Sclerosis

Keywords

  • Tecfidera
  • DMF
  • dimethyl fumarate
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 218 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.

Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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/Exclusion criteria may apply

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
218 participants (actual)

Study arms

  • Experimental
    dimethyl fumarate

    120 mg twice daily (BID) for the first 7 days and 240 mg BID thereafter

    Drug: dimethyl fumarate

Interventions

  • Drugdimethyl fumarate

    Initial oral dose for 7 days with maintenance dose thereafter

    Also known as: BG00012, Tecfidera, DMF

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

07

Results

Posted Jun 27, 2019

Participant flow

This study was conducted from 11 August 2015 to 23 April 2018 in Belgium, Bulgaria, Lithuania, Kuwait, Poland and United States.

Participant flow — Overall Study
MilestoneDimethyl Fumarate (BG00012)
Started218
Completed158
Not completed60
Withdrew: Other1
Withdrew: Investigator decision1
Withdrew: Consent withdrawn22
Withdrew: Non-compliance with study drug3
Withdrew: Adverse event17
Withdrew: Lost to follow-up7
Withdrew: Disease progression, defined by protocol2
Withdrew: Disease relapse4
Withdrew: Alternative treatment for ms2
Withdrew: New lesions in brain1

Outcome measures

PrimaryChange 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
Reported as:
Mean · cells per cubic millimeter (cells/mm^3)
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
cells per cubic millimeter (cells/mm^3)Dimethyl Fumarate (BG00012)
B Cells: Baseline235.9 ± 168.88
B Cells: Change at Week 4-18.8 ± 89.71
B Cells: Change at Week 8-48.2 ± 122.20
B Cells: Change at Week 12-65.9 ± 128.53
B Cells: Change at Week 24-76.5 ± 140.33
B Cells: Change at Week 36-70.1 ± 104.80
B Cells: Change at Week 48-60.7 ± 115.26
NK Cells: Baseline184.2 ± 107.12
NK Cells: Change at Week 46.1 ± 84.66
NK Cells: Change at Week 8-9.0 ± 89.55
NK Cells: Change at Week 12-21.7 ± 90.82
NK Cells: Change at Week 24-26.9 ± 88.06
NK Cells: Change at Week 36-41.5 ± 90.37
NK Cells: Change at Week 48-42.0 ± 104.88
T Cells: Baseline1318.1 ± 544.00
T Cells: Change at Week 4-44.8 ± 383.55
T Cells: Change at Week 8-167.0 ± 482.86
T Cells: Change at Week 12-284.3 ± 527.58
T Cells: Change at Week 24-446.7 ± 542.06
T Cells: Change at Week 36-545.5 ± 550.87
T Cells: Change at Week 48-580.2 ± 551.52
CD4+ T cells: Baseline879.0 ± 400.71
CD4+ T cells: Change at Week 4-27.4 ± 256.21
CD4+ T cells: Change at Week 8-95.4 ± 318.07
CD4+ T cells: Change at Week 12-176.8 ± 353.52
CD4+ T cells: Change at Week 24-269.8 ± 360.92
CD4+ T cells: Change at Week 36-329.7 ± 374.66
CD4+ T cells: Change at Week 48-352.6 ± 380.77
CD8+ T cells: Baseline419.5 ± 203.76
CD8+ T cells:Change at Week 4-14.2 ± 147.21
CD8+ T cells:Change at Week 8-65.3 ± 181.65
CD8+ T cells:Change at Week 12-100.4 ± 193.28
CD8+ T cells:Change at Week 24-170.2 ± 201.14
CD8+ T cells:Change at Week 36-201.4 ± 203.10
CD8+ T cells:Change at Week 48-214.9 ± 203.62
PrimaryChange 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
Reported as:
Mean · cells/mm^3
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
cells/mm^3Dimethyl Fumarate (BG00012)
Activated CD4+ T-cell [CD38+]: Baseline632.6 ± 305.86
Activated CD4+ T-cell [CD38+]: Change at Week 415.2 ± 241.73
Activated CD4+ T-cell [CD38+]: Change at Week 8-26.5 ± 241.47
Activated CD4+ T-cell [CD38+]: Change at Week 12-53.4 ± 246.22
Activated CD4+ T-cell [CD38+]: Change at Week 24-100.4 ± 263.58
Activated CD4+ T-cell [CD38+]: Change at Week 36-106.8 ± 308.03
Activated CD4+ T-cell [CD38+]: Change at Week 48-125.9 ± 273.26
Activated CD8+ T-cell ([CD38+HLA-DR+]): Baseline22.9 ± 25.64
ActivatedCD8+T-cell(CD38+HLA-DR+):CW 43.9 ± 21.83
ActivatedCD8+T-cell(CD38+HLA-DR+):CW 8-2.2 ± 24.46
ActivatedCD8+T-cell(CD38+HLA-DR+):CW 12-3.4 ± 23.53
ActivatedCD8+T-cell(CD38+HLA-DR+):CW 24-5.8 ± 24.72
ActivatedCD8+T-cell(CD38+HLA-DR+):CW 36-7.9 ± 27.32
ActivatedCD8+T-cell(CD38+HLA-DR+):CW 48-7.7 ± 24.92
Activated CD8+ T-cell [CD38+]: Baseline275.4 ± 158.04
Activated CD8+ T-cell [CD38+]: Change at Week 418.2 ± 118.67
Activated CD8+ T-cell [CD38+]: Change at Week 8-21.7 ± 126.38
Activated CD8+ T-cell [CD38+]: Change at Week 12-50.8 ± 132.08
Activated CD8+ T-cell [CD38+]: Change at Week 24-91.8 ± 142.99
Activated CD8+ T-cell [CD38+]: Change at Week 36-99.3 ± 162.79
Activated CD8+ T-cell [CD38+]: Change at Week 48-114.3 ± 152.39
Activated Th1 phenotype: Baseline10.4 ± 6.52
Activated Th1 phenotype: Change at Week 40.6 ± 6.09
Activated Th1 phenotype: Change at Week 8-1.2 ± 6.87
Activated Th1 phenotype: Change at Week 12-2.1 ± 6.63
Activated Th1 phenotype: Change at Week 24-3.5 ± 6.47
Activated Th1 phenotype: Change at Week 36-3.8 ± 6.82
Activated Th1 phenotype: Change at Week 48-4.0 ± 6.50
Activated Th17 phenotype: Baseline1.1 ± 1.33
Activated Th17 phenotype: Change at Week 40.0 ± 1.01
Activated Th17 phenotype: Change at Week 8-0.2 ± 1.50
Activated Th17 phenotype: Change at Week 120.0 ± 1.36
Activated Th17 phenotype: Change at Week 24-0.4 ± 1.33
Activated Th17 phenotype: Change at Week 36-0.4 ± 0.96
Activated Th17 phenotype: Change at Week 48-0.3 ± 1.06
Activated Th2-enriched phenotype: Baseline4.8 ± 4.83
Activated Th2-enriched phenotype: Change at Week 41.2 ± 5.36
Activated Th2-enriched phenotype: Change at Week 80.4 ± 6.13
Activated Th2-enriched phenotype: CW 120.5 ± 6.54
Activated Th2-enriched phenotype: CW 240.6 ± 6.84
Activated Th2-enriched phenotype: CW 360.3 ± 6.57
Activated Th2-enriched phenotype: CW 480.2 ± 5.14
Activated CD4+ T-cell [CD38+HLA-DR+]: Baseline17.3 ± 12.77
ActivatedCD4+ T-cell[CD38+HLA-DR+]:CW 42.5 ± 11.63
ActivatedCD4+ T-cell[CD38+HLA-DR+]:CW 8-0.3 ± 12.81
ActivatedCD4+ T-cell[CD38+HLA-DR+]:CW 12-1.6 ± 12.10
ActivatedCD4+ T-cell[CD38+HLA-DR+]:CW 24-3.2 ± 13.54
ActivatedCD4+ T-cell[CD38+HLA-DR+]:CW 36-4.1 ± 12.07
ActivatedCD4+ T-cell[CD38+HLA-DR+]:CW 48-4.2 ± 11.62
Activated CD4+ T-cell [HLA-DR+]: Baseline64.6 ± 32.45
Activated CD4+ T-cell [HLA-DR+]: Change at Week 41.4 ± 27.95
Activated CD4+ T-cell [HLA-DR+]: Change at Week 8-5.1 ± 38.57
Activated CD4+ T-cell [HLA-DR+]: Change at Week 12-11.7 ± 31.71
Activated CD4+ T-cell [HLA-DR+]: Change at Week 24-26.0 ± 30.09
Activated CD4+ T-cell [HLA-DR+]: Change at Week 36-33.6 ± 36.39
Activated CD4+ T-cell [HLA-DR+]: Change at Week 48-30.1 ± 38.57
Activated CD8+ T-cell [HLA-DR+]: Baseline81.2 ± 63.34
Activated CD8+ T-cell [HLA-DR+]: Change at Week 42.5 ± 46.91
Activated CD8+ T-cell [HLA-DR+]: Change at Week 8-5.5 ± 67.56
Activated CD8+ T-cell [HLA-DR+]: Change at Week 12-18.2 ± 59.58
Activated CD8+ T-cell [HLA-DR+]: Change at Week 24-38.1 ± 57.42
Activated CD8+ T-cell [HLA-DR+]: Change at Week 36-48.3 ± 63.85
Activated CD8+ T-cell [HLA-DR+]: Change at Week 48-49.3 ± 59.85
CM CD4+ T-cell [CD45RA-CCR7+]: Baseline433.4 ± 220.05
CM CD4+ T-cell[CD45RA-CCR7+]:CW 4-21.0 ± 185.07
CM CD4+ T-cell[CD45RA-CCR7+]:CW 8-68.0 ± 196.02
CM CD4+T-cell[CD45RA-CCR7+]:CW 12-105.3 ± 206.11
CM CD4+T-cell[CD45RA-CCR7+]:CW 24-204.2 ± 220.61
CentralMemoryCD4+T-cell[CD45RA-CCR7+]:CW 36-235.7 ± 221.44
CM CD4+T-cell[CD45RA-CCR7+]:CW 48-231.1 ± 225.25
CM CD8+ T-cell [CD45RA-CCR7+]: Baseline59.9 ± 60.38
CM CD8+T-cell[CD45RA-CCR7+]:CW 4-9.6 ± 45.92
CM CD8+T-cell[CD45RA-CCR7+]:CW 8-16.9 ± 41.72
CM CD8+T-cell[CD45RA-CCR7+]:CW 12-22.0 ± 48.10
CM CD8+T-cell[CD45RA-CCR7+]:CW 24-39.2 ± 50.00
CM CD8+T-cell[CD45RA-CCR7+]:CW 36-44.3 ± 55.66
CM CD8+T-cell[CD45RA-CCR7+]:CW 48-45.9 ± 53.78
Effector CD4+ T-cell [CD45RA+CCR7-]: Baseline12.0 ± 23.21
Effector CD4+ T-cell[CD45RA+CCR7-]:Change atWeek40.8 ± 12.66
Effector CD4+ T-cell[CD45RA+CCR7-]:Change atWeek8-0.1 ± 12.58
Effector CD4+ T-cell[CD45RA+CCR7-]:Change atWeek12-1.0 ± 12.43
Effector CD4+ T-cell[CD45RA+CCR7-]:CW 24-1.6 ± 17.42
Effector CD4+ T-cell[CD45RA+CCR7-]:CW 36-1.9 ± 19.20
Effector CD4+ T-cell[CD45RA+CCR7-]:CW 48-4.7 ± 18.75
Effector CD8+ T-cell [CD45RA+CCR7-]: Baseline101.4 ± 91.95
Effector CD8+ T-cell[CD45RA+CCR7-]:Change atWeek41.7 ± 63.49
Effector CD8+ T-cell[CD45RA+CCR7-]:Change atWeek8-15.9 ± 67.93
Effector CD8+ T-cell[CD45RA+CCR7-]:CW 12-15.2 ± 80.78
Effector CD8+ T-cell[CD45RA+CCR7-]:CW 24-42.8 ± 74.14
Effector CD8+ T-cell[CD45RA+CCR7-]:CW 36-55.6 ± 78.88
Effector CD8+ T-cell[CD45RA+CCR7-]:CW 48-50.9 ± 82.46
EM CD4+ T-cell [CD45RA-CCR7-]: Baseline179.7 ± 86.21
EM CD4+ T-cell [CD45RA-CCR7-]: Change at Week 410.9 ± 87.56
EM CD4+ T-cell [CD45RA-CCR7-]: Change at Week 8-33.2 ± 88.53
EM CD4+ T-cell [CD45RA-CCR7-]: Change at Week 12-55.2 ± 90.59
EM CD4+ T-cell [CD45RA-CCR7-]: Change at Week 24-81.7 ± 106.78
EM CD4+ T-cell [CD45RA-CCR7-]: Change at Week 36-98.1 ± 111.77
EM CD4+ T-cell [CD45RA-CCR7-]: Change at Week 48-118.5 ± 100.25
EM CD8+ T-cell [CD45RA-CCR7-]: Baseline129.0 ± 92.24
EM CD8+ T-cell [CD45RA-CCR7-]: Change at Week 47.6 ± 82.42
EM CD8+ T-cell [CD45RA-CCR7-]: Change at Week 8-22.8 ± 88.05
EM CD8+ T-cell [CD45RA-CCR7-]: Change at Week 12-41.0 ± 85.82
EM CD8+ T-cell [CD45RA-CCR7-]: Change at Week 24-69.9 ± 90.17
EM CD8+ T-cell [CD45RA-CCR7-]: Change at Week 36-80.3 ± 96.19
EM CD8+ T-cell [CD45RA-CCR7-]: Change at Week 48-90.3 ± 97.07
Effector Regulatory T-cells: Baseline56.1 ± 28.88
Effector Regulatory T-cells: Change at Week 40.6 ± 26.13
Effector Regulatory T-cells: Change at Week 8-7.1 ± 27.32
Effector Regulatory T-cells: Change at Week 12-12.7 ± 25.81
Effector Regulatory T-cells: Change at Week 24-20.3 ± 28.31
Effector Regulatory T-cells: Change at Week 36-25.8 ± 31.50
Effector Regulatory T-cells: Change at Week 48-25.1 ± 29.73
Memory CD4+ T-cell [CD45RA-]: Baseline617.7 ± 256.07
Memory CD4+ T-cell [CD45RA-]: Change at Week 4-6.2 ± 233.54
Memory CD4+ T-cell [CD45RA-]: Change at Week 8-100.9 ± 252.99
Memory CD4+ T-cell [CD45RA-]: Change at Week 12-157.7 ± 269.36
Memory CD4+ T-cell [CD45RA-]: Change at Week 24-287.7 ± 291.97
Memory CD4+ T-cell [CD45RA-]: Change at Week 36-335.0 ± 299.23
Memory CD4+ T-cell [CD45RA-]: Change at Week 48-349.9 ± 289.24
Memory CD8+ T-cell [CD45RA-]: Baseline187.5 ± 126.58
Memory CD8+ T-cell [CD45RA-]: Change at Week 4-4.7 ± 97.59
Memory CD8+ T-cell [CD45RA-]: Change at Week 8-40.9 ± 109.49
Memory CD8+ T-cell [CD45RA-]: Change at Week 12-64.0 ± 118.89
Memory CD8+ T-cell [CD45RA-]: Change at Week 24-108.6 ± 119.94
Memory CD8+ T-cell [CD45RA-]: Change at Week 36-124.9 ± 126.30
Memory CD8+ T-cell [CD45RA-]: Change at Week 48-136.3 ± 129.68
Naïve CD4+ T-cell [CD45RA+CCR7+]: Baseline400.9 ± 261.16
Naïve CD4+ T-cell [CD45RA+CCR7+]: Change at Week 4-10.5 ± 175.86
Naïve CD4+ T-cell [CD45RA+CCR7+]: Change at Week 8-16.4 ± 169.60
Naïve CD4+ T-cell[CD45RA+CCR7+]:Change at Week 12-11.8 ± 177.35
Naïve CD4+ T-cell[CD45RA+CCR7+]:Change at Week 24-31.7 ± 190.17
Naïve CD4+ T-cell[CD45RA+CCR7+]:Change at Week 36-29.3 ± 204.15
Naïve CD4+ T-cell[CD45RA+CCR7+]:Change at Week 48-34.4 ± 197.57
Naïve CD4+ T-cell [CD45RA+]: Baseline416.7 ± 268.35
Naïve CD4+ T-cell [CD45RA+]: Change at Week 4-8.6 ± 177.59
Naïve CD4+ T-cell [CD45RA+]: Change at Week 8-15.6 ± 173.25
Naïve CD4+ T-cell [CD45RA+]: Change at Week 12-10.2 ± 185.67
Naïve CD4+ T-cell [CD45RA+]: Change at Week 24-33.6 ± 193.78
Naïve CD4+ T-cell [CD45RA+]: Change at Week 36-30.2 ± 214.46
Naïve CD4+ T-cell [CD45RA+]: Change at Week 48-37.0 ± 206.10
Naïve CD8+ T-cell [CD45RA+CCR7+]: Baseline160.1 ± 108.32
Naïve CD8+ T-cell [CD45RA+CCR7+]: Change at Week 4-11.6 ± 79.05
Naïve CD8+ T-cell [CD45RA+CCR7+]: Change at Week 8-12.4 ± 75.66
Naïve CD8+ T-cell[CD45RA+CCR7+]:Change at Week 12-22.0 ± 73.23
Naïve CD8+ T-cell[CD45RA+CCR7+]:Change at Week 24-41.3 ± 77.22
Naïve CD8+ T-cell[CD45RA+CCR7+]:Change at Week 36-49.0 ± 88.78
Naïve CD8+ T-cell[CD45RA+CCR7+]:Change at Week 48-50.9 ± 80.43
Naïve CD8+ T-cell [CD45RA+]: Baseline258.0 ± 150.73
Naïve CD8+ T-cell [CD45RA+]: Change at Week 4-11.7 ± 118.68
Naïve CD8+ T-cell [CD45RA+]: Change at Week 8-28.3 ± 118.33
Naïve CD8+ T-cell [CD45RA+]: Change at Week 12-39.7 ± 131.27
Naïve CD8+ T-cell [CD45RA+]: Change at Week 24-82.4 ± 134.00
Naïve CD8+ T-cell [CD45RA+]: Change at Week 36-106.1 ± 139.47
Naïve CD8+ T-cell [CD45RA+]: Change at Week 48-103.4 ± 138.84
Naïve Regulatory T-cells: Baseline15.8 ± 13.44
Naïve Regulatory T-cells: Change at Week 4-0.1 ± 11.90
Naïve Regulatory T-cells: Change at Week 8-0.4 ± 12.19
Naïve Regulatory T-cells: Change at Week 12-0.7 ± 9.84
Naïve Regulatory T-cells: Change at Week 24-0.4 ± 11.87
Naïve Regulatory T-cells: Change at Week 360.1 ± 12.07
Naïve Regulatory T-cells: Change at Week 48-0.1 ± 10.25
Regulatory T-cells: Baseline71.5 ± 36.60
Regulatory T-cells: Change at Week 41.0 ± 34.31
Regulatory T-cells: Change at Week 8-7.3 ± 35.01
Regulatory T-cells: Change at Week 12-13.3 ± 32.12
Regulatory T-cells: Change at Week 24-20.0 ± 36.77
Regulatory T-cells: Change at Week 36-25.7 ± 40.18
Regulatory T-cells: Change at Week 48-24.4 ± 36.09
Terminal Effector Regulatory T-cells: Baseline327.2 ± 168.48
Terminal Effector Regulatory T-cells: CW 416.6 ± 158.45
Terminal Effector Regulatory T-cells: CW 8-4.4 ± 167.36
Terminal Effector Regulatory T-cells: CW 12-17.6 ± 167.80
Terminal Effector Regulatory T-cells: CW 24-58.3 ± 174.97
Terminal Effector Regulatory T-cells: CW 36-97.2 ± 199.08
Terminal Effector Regulatory T-cells: CW 48-98.6 ± 186.01
Th1 phenotype: Baseline329.5 ± 153.17
Th1 phenotype: Change at Week 4-14.7 ± 127.21
Th1 phenotype: Change at Week 8-65.4 ± 147.25
Th1 phenotype: Change at Week 12-102.1 ± 149.63
Th1 phenotype: Change at Week 24-159.2 ± 172.24
Th1 phenotype: Change at Week 36-183.0 ± 177.40
Th1 phenotype: Change at Week 48-187.4 ± 172.19
Th17 phenotype: Baseline61.9 ± 40.76
Th17 phenotype: Change at Week 4-0.5 ± 37.46
Th17 phenotype: Change at Week 8-7.3 ± 39.10
Th17 phenotype: Change at Week 12-1.1 ± 45.74
Th17 phenotype: Change at Week 24-24.6 ± 42.79
Th17 phenotype: Change at Week 36-35.1 ± 39.56
Th17 phenotype: Change at Week 48-30.1 ± 39.12
Th2-enriched phenotype: Baseline562.7 ± 289.42
Th2-enriched phenotype: Change at Week 4-0.6 ± 211.18
Th2-enriched phenotype: Change at Week 8-31.5 ± 227.69
Th2-enriched phenotype: Change at Week 12-54.0 ± 210.95
Th2-enriched phenotype: Change at Week 24-96.7 ± 241.83
Th2-enriched phenotype: Change at Week 36-97.7 ± 267.45
Th2-enriched phenotype: Change at Week 48-125.2 ± 242.46
PrimaryChange 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
Reported as:
Mean · cells/mm^3
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
cells/mm^3Dimethyl Fumarate (BG00012)
CD10+ Transitional B cells: Baseline9.4 ± 9.93
CD10+ Transitional B cells: Change at Week 4-1.2 ± 7.98
CD10+ Transitional B cells: Change at Week 8-0.4 ± 8.73
CD10+ Transitional B cells: Change at Week 12-0.4 ± 9.09
CD10+ Transitional B cells: Change at Week 243.6 ± 10.16
CD10+ Transitional B cells: Change at Week 362.8 ± 9.53
CD10+ Transitional B cells: Change at Week 485.7 ± 13.53
CD138+ Plasma Cells: Baseline0.26 ± 0.289
CD138+ Plasma Cells: Change at Week 4-0.02 ± 0.367
CD138+ Plasma Cells: Change at Week 8-0.12 ± 0.291
CD138+ Plasma Cells: Change at Week 12-0.15 ± 0.288
CD138+ Plasma Cells: Change at Week 24-0.21 ± 0.297
CD138+ Plasma Cells: Change at Week 36-0.21 ± 0.327
CD138+ Plasma Cells: Change at Week 48-0.19 ± 0.318
IgD+ Memory B cells [non-class switched]: Baseline37.8 ± 36.96
IgD+ Memory B cells[non-class switched]: CW 4-8.9 ± 26.18
IgD+ Memory B cells[non-class switched]: CW 8-12.4 ± 29.27
IgD+ Memory B cells[non-class switched]: CW 12-12.1 ± 29.13
IgD+ Memory B cells[non-class switched]: CW 24-17.6 ± 31.39
IgD+ Memory B cells[non-class switched]: CW 36-19.6 ± 31.61
IgD+ Memory B cells [non-class switched]: CW 48-13.4 ± 34.89
IgD- Memory B cells [class switched]: Baseline50.4 ± 56.97
IgD- Memory B cells [class switched]: CW 4-8.7 ± 32.20
IgD- Memory B cells [class switched]: CW 8-17.7 ± 44.42
IgD- Memory B cells [class switched]: CW 12-23.1 ± 44.76
IgD- Memory B cells [class switched]: CW 24-29.5 ± 49.95
IgD- Memory B cells [class switched]: CW 3649.95 ± 32.64
IgD- Memory B cells [class switched]: CW 48-27.4 ± 38.33
Naïve B cells: Baseline197.2 ± 140.48
Naïve B cells: Change at Week 4-21.5 ± 82.43
Naïve B cells: Change at Week 8-37.2 ± 95.32
Naïve B cells: Change at Week 12-43.1 ± 99.72
Naïve B cells: Change at Week 24-45.7 ± 114.46
Naïve B cells: Change at Week 36-54.0 ± 94.94
Naïve B cells: Change at Week 48-35.6 ± 107.79
Plasma Cells [CD10-]: Baseline0.63 ± 0.668
Plasma Cells [CD10-]: Change at Week 4-0.02 ± 0.816
Plasma Cells [CD10-]: Change at Week 8-0.11 ± 0.643
Plasma Cells [CD10-]: Change at Week 12-0.18 ± 0.647
Plasma Cells [CD10-]: Change at Week 24-0.34 ± 0.649
Plasma Cells [CD10-]: Change at Week 36-0.33 ± 0.786
Plasma Cells [CD10-]: Change at Week 48-0.38 ± 0.633
Transitional B-cells: Baseline13.6 ± 13.61
Transitional B-cells: Change at Week 4-1.3 ± 11.44
Transitional B-cells: Change at Week 80.6 ± 12.97
Transitional B-cells: Change at Week 120.7 ± 13.41
Transitional B-cells: Change at Week 245.8 ± 15.60
Transitional B-cells: Change at Week 364.2 ± 13.20
Transitional B-cells: Change at Week 487.3 ± 18.56
Plasmablasts: Baseline0.91 ± 1.104
Plasmablasts: Change at Week 4-0.04 ± 1.120
Plasmablasts: Change at Week 8-0.21 ± 1.062
Plasmablasts: Change at Week 12-0.31 ± 1.024
Plasmablasts: Change at Week 24-0.46 ± 1.106
Plasmablasts: Change at Week 36-0.46 ± 1.228
Plasmablasts: Change at Week 48-0.50 ± 1.084
PrimaryChange 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
Reported as:
Mean · cells/mm^3
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
cells/mm^3Dimethyl Fumarate (BG00012)
CD56Bright NK cells: Baseline14.0 ± 8.94
CD56Bright NK cells: Change at Week 41.8 ± 6.40
CD56Bright NK cells: Change at Week 81.8 ± 7.07
CD56Bright NK cells: Change at Week 121.3 ± 7.26
CD56Bright NK cells: Change at Week 242.1 ± 8.57
CD56Bright NK cells: Change at Week 362.3 ± 9.73
CD56Bright NK cells: Change at Week 482.1 ± 8.55
CD56Dim NK cells: Baseline192.9 ± 130.45
CD56Dim NK cells: Change at Week 4-2.0 ± 102.59
CD56Dim NK cells: Change at Week 8-17.2 ± 102.92
CD56Dim NK cells: Change at Week 12-31.4 ± 92.14
CD56Dim NK cells: Change at Week 24-50.7 ± 101.34
CD56Dim NK cells: Change at Week 36-61.1 ± 102.96
CD56Dim NK cells: Change at Week 48-68.5 ± 129.83
Classical Monocytes: Baseline301.4 ± 153.48
Classical Monocytes: Change at Week 47.5 ± 182.11
Classical Monocytes: Change at Week 86.0 ± 165.07
Classical Monocytes: Change at Week 129.3 ± 197.84
Classical Monocytes: Change at Week 24-8.7 ± 151.23
Classical Monocytes: Change at Week 36-1.5 ± 163.62
Classical Monocytes: Change at Week 48-0.8 ± 153.24
Myeloid dendritic cells: Baseline24.96 ± 16.315
Myeloid dendritic cells: Change at Week 41.46 ± 18.111
Myeloid dendritic cells: Change at Week 8-0.61 ± 17.670
Myeloid dendritic cells: Change at Week 12-0.23 ± 17.932
Myeloid dendritic cells: Change at Week 243.02 ± 17.882
Myeloid dendritic cells: Change at Week 363.63 ± 18.779
Myeloid dendritic cells: Change at Week 48-6.20 ± 17.780
Non-classical Monocytes: Baseline32.0 ± 22.88
Non-classical Monocytes: Change at Week 42.2 ± 29.82
Non-classical Monocytes: Change at Week 8-1.9 ± 30.14
Non-classical Monocytes: Change at Week 12-10.8 ± 23.82
Non-classical Monocytes: Change at Week 24-6.9 ± 27.65
Non-classical Monocytes: Change at Week 36-10.6 ± 24.24
Non-classical Monocytes: Change at Week 48-9.2 ± 24.37
Plasmacytoid dendritic cells: Baseline6.52 ± 4.617
Plasmacytoid dendritic cells: Change at Week 40.00 ± 5.168
Plasmacytoid dendritic cells: Change at Week 80.30 ± 6.427
Plasmacytoid dendritic cells: Change at Week 12-0.86 ± 4.575
Plasmacytoid dendritic cells: Change at Week 24-0.69 ± 4.138
Plasmacytoid dendritic cells: Change at Week 36-0.80 ± 4.086
Plasmacytoid dendritic cells: Change at Week 48-2.22 ± 4.509
Total dendritic cells: Baseline35.4 ± 19.92
Total dendritic cells: Change at Week 42.0 ± 22.35
Total dendritic cells: Change at Week 8-1.3 ± 21.68
Total dendritic cells: Change at Week 12-1.9 ± 21.07
Total dendritic cells: Change at Week 241.6 ± 21.89
Total dendritic cells: Change at Week 362.5 ± 22.19
Total dendritic cells: Change at Week 48-9.1 ± 22.77
Total monocytes [CD14+]: Baseline374.6 ± 179.05
Total monocytes [CD14+]: Change at Week 426.9 ± 201.63
Total monocytes [CD14+]: Change at Week 812.6 ± 189.91
Total monocytes [CD14+]: Change at Week 1214.4 ± 211.67
Total monocytes [CD14+]: Change at Week 24-19.3 ± 174.82
Total monocytes [CD14+]: Change at Week 36-21.7 ± 186.41
Total monocytes [CD14+]: Change at Week 48-19.2 ± 175.10
PrimaryChange 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
Reported as:
Mean · cells/mm^3
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
cells/mm^3Dimethyl Fumarate (BG00012)
IFNg+ (% of CD4+ T cells): Baseline3.340 ± 2.7365
IFNg+ (% of CD4+ T cells): Change at Week 40.090 ± 2.2350
IFNg+ (% of CD4+ T cells): Change at Week 8-0.356 ± 1.9676
IFNg+ (% of CD4+ T cells): Change at Week12-0.729 ± 2.1570
IFNg+ (% of CD4+ T cells): Change at Week24-1.134 ± 2.4239
IFNg+ (% of CD4+ T cells): Change at Week36-1.511 ± 2.5109
IFNg+ (% of CD4+ T cells): Change at Week48-1.222 ± 2.3513
IFNg+ (% of CD8+ T cells): Baseline6.166 ± 4.6199
IFNg+ (% of CD8+ T cells): Change at Week 40.493 ± 2.8636
IFNg+ (% of CD8+ T cells): Change at Week 8-0.264 ± 3.0735
IFNg+ (% of CD8+ T cells): Change at Week12-1.345 ± 3.3647
IFNg+ (% of CD8+ T cells): Change at Week24-1.650 ± 2.7202
IFNg+ (% of CD8+ T cells): Change at Week36-1.922 ± 4.1425
IFNg+ (% of CD8+ T cells): Change at Week48-1.306 ± 4.3931
IFNg+ (% of memory CD4+ T cells): Baseline4.518 ± 3.0417
IFNg+ (% of memory CD4+ T cells): CW 40.050 ± 2.5996
IFNg+ (% of memory CD4+ T cells): CW 8-0.295 ± 2.6287
IFNg+ (% of memory CD4+ T cells): CW 12-0.851 ± 2.8590
IFNg+ (% of memory CD4+ T cells): CW 24-1.019 ± 2.8120
IFNg+ (% of memory CD4+ T cells): CW 36-1.804 ± 2.6448
IFNg+ (% of memory CD4+ T cells): CW 48-1.369 ± 3.0958
IFNg+ (% of memory CD8+ T cells): Baseline8.795 ± 5.9060
IFNg+ (% of memory CD8+ T cells): CW 40.360 ± 3.6006
IFNg+ (% of memory CD8+ T cells): CW 8-0.285 ± 4.2645
IFNg+ (% of memory CD8+ T cells): CW 12-1.543 ± 3.7393
IFNg+ (% of memory CD8+ T cells): CW 24-0.964 ± 3.6799
IFNg+ (% of memory CD8+ T cells): CW 36-2.035 ± 5.3349
IFNg+ (% of memory CD8+ T cells): CW 48-0.497 ± 5.3126
IL-17A+/IFNg- (% of CD4+ T cells): Baseline1.244 ± 1.5863
IL-17A+/IFNg- (% of CD4+ T cells):Change at Week40.115 ± 1.9918
IL-17A+/IFNg- (% of CD4+ T cells):Change at Week80.131 ± 1.9097
IL-17A+/IFNg- (% of CD4+ T cells):Change at Week120.470 ± 2.3445
IL-17A+/IFNg- (% of CD4+ T cells):Change at Week240.165 ± 2.0104
IL-17A+/IFNg- (% of CD4+ T cells):Change at Week360.419 ± 2.5007
IL-17A+/IFNg- (% of CD4+ T cells):Change at Week481.693 ± 4.2412
IL-17A+/IFNg- (% of CD8+ T cells): Baseline0.455 ± 0.5309
IL-17A+/IFNg- (% of CD8+ T cells):Change at Week40.239 ± 1.3557
IL-17A+/IFNg- (% of CD8+ T cells):Change at Week80.032 ± 0.6448
IL-17A+/IFNg- (% of CD8+ T cells):Change at Week120.301 ± 0.8912
IL-17A+/IFNg- (% of CD8+ T cells):Change at Week240.289 ± 0.8526
IL-17A+/IFNg- (% of CD8+ T cells):Change at Week360.911 ± 1.3499
IL-17A+/IFNg- (% of CD8+ T cells):Change at Week481.457 ± 2.1499
IL-17A+/IFNg- (% of memory CD4+ T cells): Baseline1.075 ± 1.1770
IL-17A+/IFNg- (% of memory CD4+T cells): CW 40.000 ± 1.3599
IL-17A+/IFNg- (% of memory CD4+T cells): CW 80.040 ± 1.3593
IL-17A+/IFNg- (% of memory CD4+T cells): CW 120.373 ± 1.7166
IL-17A+/IFNg- (% of memory CD4+T cells): CW 240.228 ± 1.4980
IL-17A+/IFNg- (% of memory CD4+T cells): CW 360.333 ± 1.8786
IL-17A+/IFNg- (% of memory CD4+T cells): CW 481.255 ± 2.9557
IL-17A+/IFNg- (% of memory CD8+ T cells): Baseline0.155 ± 0.2356
IL-17A+/IFNg- (% of memory CD8+T cells): CW 40.113 ± 0.6972
IL-17A+/IFNg- (% of memory CD8+T cells): CW 80.027 ± 0.3641
IL-17A+/IFNg- (% of memory CD8+T cells): CW 120.064 ± 0.3641
IL-17A+/IFNg- (% of memory CD8+T cells): CW 240.254 ± 0.8682
IL-17A+/IFNg- (% of memory CD8+T cells): CW 360.270 ± 0.6113
IL-17A+/IFNg- (% of memory CD8+T cells): CW 480.680 ± 1.2842
IL-2+ (% of CD4+ T cells): Baseline5.177 ± 4.5225
IL-2+ (% of CD4+ T cells): Change at Week 40.062 ± 3.4662
IL-2+ (% of CD4+ T cells): Change at Week 80.149 ± 4.0713
IL-2+ (% of CD4+ T cells): Change at Week 12-0.069 ± 4.0822
IL-2+ (% of CD4+ T cells): Change at Week 24-0.448 ± 3.6280
IL-2+ (% of CD4+ T cells): Change at Week 36-1.837 ± 3.8603
IL-2+ (% of CD4+ T cells): Change at Week 48-1.840 ± 5.0951
IL-2+ (% of CD8+ T cells): Baseline1.180 ± 1.4533
IL-2+ (% of CD8+ T cells): Change at Week 4-0.081 ± 1.2797
IL-2+ (% of CD8+ T cells): Change at Week 8-0.227 ± 1.1579
IL-2+ (% of CD8+ T cells): Change at Week 12-0.2622 ± 1.2601
IL-2+ (% of CD8+ T cells): Change at Week 24-0.525 ± 1.0201
IL-2+ (% of CD8+ T cells): Change at Week 36-0.547 ± 1.2886
IL-2+ (% of CD8+ T cells): Change at Week 48-0.248 ± 1.1860
IL-2+ (% of memory CD4+ T cells): Baseline7.053 ± 5.6653
IL-2+ (% of memory CD4+ T cells): Change at Week 4-0.105 ± 4.4131
IL-2+ (% of memory CD4+ T cells): Change at Week 80.056 ± 4.6541
IL-2+ (% of memory CD4+ T cells): Change at Week120.012 ± 4.9241
IL-2+ (% of memory CD4+ T cells): Change at Week240.015 ± 4.6456
IL-2+ (% of memory CD4+ T cells): Change at Week36-2.140 ± 4.7723
IL-2+ (% of memory CD4+ T cells): Change at Week48-1.946 ± 5.6985
IL-2+ (% of memory CD8+ T cells): Baseline1.879 ± 1.7964
IL-2+ (% of memory CD8+ T cells): Change at Week 4-0.218 ± 1.6838
IL-2+ (% of memory CD8+ T cells): Change at Week 8-0.318 ± 1.7272
IL-2+ (% of memory CD8+ T cells): Change at Week12-0.115 ± 1.7354
IL-2+ (% of memory CD8+ T cells): Change at Week24-0.461 ± 1.4512
IL-2+ (% of memory CD8+ T cells): Change at Week36-0.803 ± 1.8525
IL-2+ (% of memory CD8+ T cells): Change at Week48-0.315 ± 2.0510
IL-4+ (% of CD4+ T cells: Baseline1.261 ± 1.1190
IL-4+ (% of CD4+ T cells): Change at Week 4-0.150 ± 1.0429
IL-4+ (% of CD4+ T cells): Change at Week 8-0.113 ± 1.2168
IL-4+ (% of CD4+ T cells): Change at Week12-0.370 ± 1.0594
IL-4+ (% of CD4+ T cells): Change at Week24-0.170 ± 1.1551
IL-4+ (% of CD4+ T cells): Change at Week36-0.376 ± 1.0920
IL-4+ (% of CD4+ T cells): Change at Week480.281 ± 4.7206
IL-4+ (% of CD8+ T cells): Baseline1.107 ± 1.2924
IL-4+ (% of CD8+ T cells): Change at Week 4-0.222 ± 1.2163
IL-4+ (% of CD8+ T cells): Change at Week 8-0.189 ± 1.3377
IL-4+ (% of CD8+ T cells): Change at Week12-0.553 ± 1.3754
IL-4+ (% of CD8+ T cells): Change at Week24-0.032 ± 1.3170
IL-4+ (% of CD8+ T cells): Change at Week36-0.195 ± 1.3334
IL-4+ (% of CD8+ T cells): Change at Week480.786 ± 1.3454
IL-4+ (% of memory CD4+ T cells): Baseline1.406 ± 1.2437
IL-4+ (% of memory CD4+ T cells): Change at Week 4-0.128 ± 1.2649
IL-4+ (% of memory CD4+ T cells): Change at Week 8-0.141 ± 1.4642
IL-4+ (% of memory CD4+ T cells): Change at Week12-0.412 ± 1.3656
IL-4+ (% of memory CD4+ T cells): Change at Week24-0.136 ± 1.3059
IL-4+ (% of memory CD4+ T cells): Change at Week36-0.266 ± 1.4005
IL-4+ (% of memory CD4+ T cells): Change at Week480.325 ± 1.7918
IL-4+ (% of memory CD8+ T cells): Baseline1.376 ± 1.8963
IL-4+ (% of memory CD8+ T cells): Change at Week 4-0.180 ± 2.0821
IL-4+ (% of memory CD8+ T cells): Change at Week 8-0.269 ± 1.9840
IL-4+ (% of memory CD8+ T cells): Change at Week12-0.795 ± 2.2486
IL-4+ (% of memory CD8+ T cells): Change at Week240.416 ± 2.3613
IL-4+ (% of memory CD8+ T cells): Change at Week36-0.284 ± 2.4433
IL-4+ (% of memory CD8+ T cells): Change at Week481.836 ± 2.7709
PrimaryChange 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
Reported as:
Mean · cells/mm^3
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
cells/mm^3Dimethyl Fumarate (BG00012)
CD11a+ (% of B cells): Baseline99.33 ± 2.106
CD11a+ (% of B cells): Change at Week 40.34 ± 2.497
CD11a+ (% of B cells): Change at Week 80.44 ± 2.203
CD11a+ (% of B cells): Change at Week 120.17 ± 2.534
CD11a+ (% of B cells): Change at Week 240.19 ± 2.549
CD11a+ (% of B cells): Change at Week 36-1.43 ± 11.406
CD11a+ (% of B cells): Change at Week 48-0.14 ± 7.751
CD11a+ (% of T cells): Baseline99.90 ± 0.312
CD11a+ (% of T cells): Change at Week 40.05 ± 0.319
CD11a+ (% of T cells): Change at Week 80.07 ± 0.327
CD11a+ (% of T cells): Change at Week 120.06 ± 0.321
CD11a+ (% of T cells): Change at Week 240.02 ± 0.633
CD11a+ (% of T cells): Change at Week 36-1.29 ± 9.760
CD11a+ (% of T cells): Change at Week 48-0.53 ± 7.410
CD11a+ (% of MNC): Baseline96.85 ± 3.089
CD11a+ (% of MNC): Change at Week 40.47 ± 3.630
CD11a+ (% of MNC): Change at Week 80.59 ± 3.532
CD11a+ (% of MNC): Change at Week 120.59 ± 3.710
CD11a+ (% of MNC): Change at Week 24-0.38 ± 3.963
CD11a+ (% of MNC): Change at Week 36-1.55 ± 10.918
CD11a+ (% of MNC): Change at Week 48-2.31 ± 8.402
CD11a+ (% of dendritic cells [CD11c++]): Baseline99.81 ± 0.933
CD11a+ (% of dendritic cells [CD11c++]): CW 40.04 ± 0.867
CD11a+ (% of dendritic cells [CD11c++]): CW 80.02 ± 1.573
CD11a+ (% of dendritic cells [CD11c++]): CW 120.10 ± 1.250
CD11a+ (% of dendritic cells [CD11c++]): CW 240.01 ± 1.477
CD11a+ (% of dendritic cells [CD11c++]): CW 36-1.27 ± 10.857
CD11a+ (% of dendritic cells [CD11c++]): CW 48-0.84 ± 7.813
CD11a+ (% of lymphocytes): Baseline98.24 ± 1.870
CD11a+ (% of lymphocytes): Change at Week 40.04 ± 2.227
CD11a+ (% of lymphocytes): Change at Week 80.07 ± 2.649
CD11a+ (% of lymphocytes): Change at Week 120.26 ± 2.604
CD11a+ (% of lymphocytes): Change at Week 24-0.35 ± 2.519
CD11a+ (% of lymphocytes): Change at Week 36-1.99 ± 10.532
CD11a+ (% of lymphocytes): Change at Week 48-2.56 ± 8.696
CD11a+ (% of monocytes): Baseline98.00 ± 2.303
CD11a+ (% of monocytes): Change at Week 40.29 ± 3.241
CD11a+ (% of monocytes): Change at Week 80.92 ± 2.416
CD11a+ (% of monocytes): Change at Week 120.77 ± 2.539
CD11a+ (% of monocytes): Change at Week 24-0.40 ± 3.046
CD11a+ (% of monocytes): Change at Week 36-0.36 ± 7.843
CD11a+ (% of monocytes): Change at Week 48-1.52 ± 7.711
CD11a+ (% of neutrophils): Baseline97.80 ± 5.352
CD11a+ (% of neutrophils): Change at Week 40.83 ± 6.672
CD11a+ (% of neutrophils): Change at Week 81.23 ± 5.675
CD11a+ (% of neutrophils): Change at Week 120.55 ± 6.113
CD11a+ (% of neutrophils): Change at Week 240.35 ± 9.220
CD11a+ (% of neutrophils): Change at Week 36-2.88 ± 18.513
CD11a+ (% of neutrophils): Change at Week 480.42 ± 10.736
CD49d+ (% of B cells): Baseline99.87 ± 0.679
CD49d+ (% of B cells): Change at Week 4-0.50 ± 7.105
CD49d+ (% of B cells): Change at Week 80.00 ± 0.642
CD49d+ (% of B cells): Change at Week 120.01 ± 0.486
CD49d+ (% of B cells): Change at Week 24-0.01 ± 0.663
CD49d+ (% of B cells): Change at Week 36-0.07 ± 0.744
CD49d+ (% of B cells): Change at Week 48-0.04 ± 0.964
CD49d+ (% of T cells): Baseline91.23 ± 4.427
CD49d+ (% of T cells): Change at Week 4-0.45 ± 6.909
CD49d+ (% of T cells): Change at Week 8-0.11 ± 2.055
CD49d+ (% of T cells): Change at Week 12-0.06 ± 1.930
CD49d+ (% of T cells): Change at Week 24-0.12 ± 2.209
CD49d+ (% of T cells): Change at Week 36-1.32 ± 4.256
CD49d+ (% of T cells): Change at Week 48-0.02 ± 2.935
CD49d+ (% of MNC): Baseline86.79 ± 5.369
CD49d+ (% of MNC): Change at Week 40.23 ± 8.274
CD49d+ (% of MNC): Change at Week 80.38 ± 5.600
CD49d+ (% of MNC): Change at Week 120.85 ± 5.900
CD49d+ (% of MNC): Change at Week 24-0.07 ± 6.051
CD49d+ (% of MNC): Change at Week 36-0.46 ± 8.264
CD49d+ (% of MNC): Change at Week 48-1.25 ± 6.561
CD49d+ (% of dendritic cells [CD11c++]): Baseline99.77 ± 0.771
CD49d+ (% of dendritic cells [CD11c++]): CW 4-0.42 ± 7.185
CD49d+ (% of dendritic cells [CD11c++]): CW 80.12 ± 0.874
CD49d+ (% of dendritic cells [CD11c++]): CW 120.03 ± 1.252
CD49d+ (% of dendritic cells [CD11c++]): CW 240.00 ± 1.162
CD49d+ (% of dendritic cells [CD11c++]): CW 36-0.06 ± 1.532
CD49d+ (% of dendritic cells [CD11c++]): CW 48-0.23 ± 1.530
CD49d+ (% of lymphocytes): Baseline91.29 ± 4.715
CD49d+ (% of lymphocytes): Change at Week 4-0.31 ± 7.260
CD49d+ (% of lymphocytes): Change at Week 80.03 ± 5.899
CD49d+ (% of lymphocytes): Change at Week 120.44 ± 2.989
CD49d+ (% of lymphocytes): Change at Week 240.01 ± 3.237
CD49d+ (% of lymphocytes): Change at Week 36-0.75 ± 5.045
CD49d+ (% of lymphocytes): Change at Week 48-1.10 ± 5.739
CD49d+ (% of monocytes): Baseline88.77 ± 8.126
CD49d+ (% of monocytes): Change at Week 40.82 ± 10.895
CD49d+ (% of monocytes): Change at Week 80.96 ± 10.161
CD49d+ (% of monocytes): Change at Week 120.82 ± 10.350
CD49d+ (% of monocytes): Change at Week 240.98 ± 9.793
CD49d+ (% of monocytes): Change at Week 363.87 ± 9.683
CD49d+ (% of monocytes): Change at Week 480.69 ± 10.594
CD49d+ (% of neutrophils): Baseline5.61 ± 7.277
CD49d+ (% of neutrophils): Change at Week 44.43 ± 9.345
CD49d+ (% of neutrophils): Change at Week 81.17 ± 4.892
CD49d+ (% of neutrophils): Change at Week 120.27 ± 4.137
CD49d+ (% of neutrophils): Change at Week 24-0.67 ± 10.365
CD49d+ (% of neutrophils): Change at Week 36-0.29 ± 12.678
CD49d+ (% of neutrophils): Change at Week 480.92 ± 10.291
SecondaryChange 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
Reported as:
Mean · milligram per liter (mg/L)
Change From Baseline in Immunoglobulin A (IgA) up to 48 Weeks
milligram per liter (mg/L)Dimethyl Fumarate (BG00012)
Baseline2116.5 ± 910.47
Change at Week 4-120.0 ± 231.16
Change at Week 8-112.8 ± 243.28
Change at Week 12-93.6 ± 291.76
Change at Week 24-101.5 ± 324.27
Change at Week 36-65.1 ± 279.53
Change at Week 48-94.9 ± 291.25
SecondaryChange 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
Reported as:
Mean · mg/L
Change From Baseline in Immunoglobulin M (IgM) up to 48 Weeks
mg/LDimethyl Fumarate (BG00012)
Baseline1330.1 ± 705.92
Change at Week 4-68.9 ± 214.07
Change at Week 8-23.2 ± 208.48
Change at Week 12-18.8 ± 270.82
Change at Week 24-36.9 ± 293.14
Change at Week 36-19.4 ± 406.86
Change at Week 48-96.8 ± 236.48
SecondaryChange 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
Reported as:
Mean · g/L
Change From Baseline in Immunoglobulin G (IgG) up to 48 Weeks
g/LDimethyl Fumarate (BG00012)
Baseline10.51 ± 2.328
Change at Week 4-0.77 ± 1.039
Change at Week 8-0.64 ± 1.077
Change at Week 12-0.44 ± 1.187
Change at Week 24-0.62 ± 1.324
Change at Week 36-0.36 ± 1.025
Change at Week 48-0.53 ± 1.142
SecondaryChange 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
Reported as:
Mean · milligram per deciliter
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
milligram per deciliterDimethyl Fumarate (BG00012)
IgG Subclass 1: Baseline542.9 ± 152.87
IgG Subclass 1: Change at Week 4-29.2 ± 68.22
IgG Subclass 1: Change at Week 8-28.5 ± 71.46
IgG Subclass 1: Change at Week 12-14.8 ± 79.07
IgG Subclass 1: Change at Week 24-3.0 ± 78.80
IgG Subclass 1: Change at Week 36-23.1 ± 61.73
IgG Subclass 1: Change at Week 48-0.5 ± 102.41
IgG Subclass 2: Baseline350.7 ± 116.43
IgG Subclass 2: Change at Week 4-22.7 ± 47.42
IgG Subclass 2: Change at Week 8-26.5 ± 48.98
IgG Subclass 2: Change at Week 12-18.9 ± 44.11
IgG Subclass 2: Change at Week 24-5.5 ± 54.39
IgG Subclass 2: Change at Week 36-22.4 ± 45.49
IgG Subclass 2: Change at Week 48-21.5 ± 50.98
IgG Subclass 3: Baseline56.93 ± 26.860
IgG Subclass 3: Change at Week 4-2.1 ± 8.56
IgG Subclass 3: Change at Week 8-0.7 ± 12.36
IgG Subclass 3: Change at Week 12-1.0 ± 15.48
IgG Subclass 3: Change at Week 24-0.4 ± 11.31
IgG Subclass 3: Change at Week 364.6 ± 19.09
IgG Subclass 3: Change at Week 481.5 ± 12.55
IgG Subclass 4: Baseline30.35 ± 29.681
IgG Subclass 4: Change at Week 41.24 ± 9.242
IgG Subclass 4: Change at Week 8-0.38 ± 10.995
IgG Subclass 4: Change at Week 12-0.12 ± 11.711
IgG Subclass 4: Change at Week 241.08 ± 15.253
IgG Subclass 4: Change at Week 361.28 ± 12.236
IgG Subclass 4: Change at Week 483.26 ± 10.962
IgG Subclasses 1-4 Quant: Baseline1029.9 ± 232.33
IgG Subclasses 1-4 Quant: Change at Week 4-54.6 ± 101.48
IgG Subclasses 1-4 Quant: Change at Week 8-41.9 ± 100.16
IgG Subclasses 1-4 Quant: Change at Week 12-28.5 ± 114.30
IgG Subclasses 1-4 Quant: Change at Week 24-55.7 ± 116.69
IgG Subclasses 1-4 Quant: Change at Week 36-70.3 ± 103.59
IgG Subclasses 1-4 Quant: Change at Week 48-65.1 ± 130.94

Adverse events

Collected over Up to 33 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Dimethyl Fumarate (BG00012)0/218 (0%)26/218 (11.9%)160/218 (73.4%)
Most frequent serious events
Showing 10 of 16
Most frequent serious events
EventDimethyl Fumarate (BG00012)
Multiple sclerosis relapseNervous system disorders16/218
Acute myocardial infarctionCardiac disorders1/218
IridocyclitisEye disorders1/218
Non-cardiac chest painGeneral disorders1/218
Cholecystitis chronicHepatobiliary disorders1/218
CellulitisInfections and infestations1/218
NasopharyngitisInfections and infestations1/218
Diabetes mellitus inadequate controlMetabolism and nutrition disorders1/218
Diabetic ketoacidosisMetabolism and nutrition disorders1/218
ArthralgiaMusculoskeletal and connective tissue disorders1/218
Most frequent other events
Showing 10 of 20
Most frequent other events
EventDimethyl Fumarate (BG00012)
FlushingVascular disorders100/218
Multiple sclerosis relapseNervous system disorders41/218
NasopharyngitisInfections and infestations33/218
DiarrhoeaGastrointestinal disorders28/218
Upper respiratory tract infectionInfections and infestations28/218
FatigueGeneral disorders27/218
Abdominal painGastrointestinal disorders22/218
Abdominal pain upperGastrointestinal disorders22/218
NauseaGastrointestinal disorders22/218
PruritusSkin and subcutaneous tissue disorders17/218

Baseline characteristics

The pharmacodynamic (PD) population was defined as all participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement after baseline.

Age, Continuous
Age, Continuous(years)Dimethyl Fumarate (BG00012)
Mean42.1 ± 10.99
Sex: Female, Male
Sex: Female, Male(Participants)Dimethyl Fumarate (BG00012)
Female151
Male67
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Dimethyl Fumarate (BG00012)
Hispanic or Latino6
Not Hispanic or Latino66
Unknown or Not Reported146
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Dimethyl Fumarate (BG00012)
American Indian or Alaska Native1
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American9
White60
More than one race3
Unknown or Not Reported145
08

Study locations

34 sites
  • Research Site
    Gilbert, Arizona 85234, United States
  • Research Site
    Long Beach, California 90806, United States
  • Research Site
    Ocala, Florida 34471, United States
  • Research Site
    Oldsmar, Florida 34677, United States
  • Research Site
    Tampa, Florida 33609, United States
  • Research Site
    Tampa, Florida 33612, United States
  • Research Site
    Atlanta, Georgia 30342, United States
  • Research Site
    Overland Park, Kansas 66212, United States
  • Research Site
    Baltimore, Maryland 33612, United States
  • Research Site
    Traverse City, Michigan 49684, United States
  • Research Site
    Raleigh, North Carolina 27607, United States
  • Research Site
    Spartanburg, South Carolina 29307, United States
  • Research Site
    San Antonio, Texas 78258, United States
  • Research Site
    Salt Lake City, Utah 84103, United States
  • Research Site
    Tacoma, Washington 98405, United States
  • Research Site
    La Louviere, Hainaut 7100, Belgium
  • Research Site
    Brugge, West-Vlaanderen 8000, Belgium
  • Research Site
    Brasschaat, 2930, Belgium
  • Research Site
    Plaven, 5800, Bulgaria
  • Research Site
    Pleven, 5800, Bulgaria
  • Research Site
    Sofia, 1113, Bulgaria
  • Research Site
    Sofia, 1606, Bulgaria
  • Research Site
    Sofia, Bulgaria
  • Research Site
    Kuwait City, 00001, Kuwait
  • Research Site
    Kaunas, LT-50009, Lithuania
  • Research Site
    Klaipeda, 92288, Lithuania
  • Research Site
    Vilnius, LT-08661, Lithuania
  • Research Site
    Bydgoszcz, 85-795, Poland
  • Research Site
    Katowice, 40-595, Poland
  • Research Site
    Katowice, 40-650, Poland
  • Research Site
    Lodz, 90-324, Poland
  • Research Site
    Plewiska, 62-064, Poland
  • Research Site
    Szczecin, 70-215, Poland
  • Research Site
    Umuttepe, Kocaeli 41380, Turkey
09

References and documents

Study documents

  • Study protocol · Jan 22, 2016
  • Statistical analysis plan · Feb 23, 2018

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02525874
Lead sponsor
Biogen
Responsible party
Sponsor
First posted
Aug 18, 2015
Start date
Aug 11, 2015
Primary completion
Apr 24, 2017
Completion
Apr 23, 2018
Results posted
Jun 27, 2019
Last update
Jun 27, 2019

Study contacts

Medical Director
study director · Biogen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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