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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
218
Initial oral dose for 7 days with maintenance dose thereafter
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
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
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
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 \[CD14+\].
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Gilbert, Arizona, United States
Research Site
Long Beach, California, United States
Research Site
Ocala, Florida, United States
Research Site
Oldsmar, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Overland Park, Kansas, United States
Research Site
Baltimore, Maryland, United States
Research Site
Traverse City, Michigan, United States
...and 24 more locations
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
T-cell cytokine subsets include IFN (interferon) g+ (% of CD4+ T cells), IFNg+ (% of CD8+ T cells), IFNg+ (% of memory CD4+ T cells), IFNg+ (% of memory CD8+ T cells), IL- (interleukin) 17A+/IFNg- (% of CD4+ T cells), IL-17A+/IFNg- (% of CD8+ T cells), IL-17A+/IFNg- (% of memory CD4+ T cells), IL-17A+/IFNg- (% of memory CD8+ T cells), IL-2+ (% of CD4+ T cells), IL-2+ (% of CD8+ T cells), IL-2+ (% of memory CD4+ T cells), IL-2+ (% of memory CD8+ T cells), IL-4+ (% of CD4+ T cells), IL-4+ (% of CD8+ T cells), IL-4+ (% of memory CD4+ T cells) and IL-4+ (% of memory CD8+ T cells). Here, Change at week is represented as CW.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
VLA-4/LFA-1 antigen subsets include CD11a+ (% of B cells), CD11a+ (% of T cells), CD11a+ (% of MNC), CD11a+ (% of dendritic cells \[CD11c++\]), CD11a+ (% of lymphocytes), CD11a+ (% of monocytes), CD11a+ (% of neutrophils), CD49d+ (% of B cells), CD49d+ (% of T cells), CD49d+ (% of MNC), CD49d+ (% of dendritic cells \[CD11c++\]), CD49d+ (% of lymphocytes), CD49d+ (% of monocytes) and CD49d+ (% of neutrophils).
Time frame: 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
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Change From Baseline in Immunoglobulin M (IgM) up to 48 Weeks
Time frame: 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
Time frame: 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
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48