An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis

CompletedPhase 3Relapsing MSNCT025258742015-001973-42

What it found

Results posted, not judged

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

Results by group

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

GroupValueIntervalNumber analysed
Dimethyl Fumarate (BG00012)235.9 cells per cubic millimeter (cells/mm^3)168.88 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-18.8 cells per cubic millimeter (cells/mm^3)89.71 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-48.2 cells per cubic millimeter (cells/mm^3)122.2 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-65.9 cells per cubic millimeter (cells/mm^3)128.53 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-76.5 cells per cubic millimeter (cells/mm^3)140.33 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-70.1 cells per cubic millimeter (cells/mm^3)104.8 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-60.7 cells per cubic millimeter (cells/mm^3)115.26 (Standard Deviation)218
Dimethyl Fumarate (BG00012)184.2 cells per cubic millimeter (cells/mm^3)107.12 (Standard Deviation)218
Dimethyl Fumarate (BG00012)6.1 cells per cubic millimeter (cells/mm^3)84.66 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-9.0 cells per cubic millimeter (cells/mm^3)89.55 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-21.7 cells per cubic millimeter (cells/mm^3)90.82 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-26.9 cells per cubic millimeter (cells/mm^3)88.06 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-41.5 cells per cubic millimeter (cells/mm^3)90.37 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-42.0 cells per cubic millimeter (cells/mm^3)104.88 (Standard Deviation)218
Dimethyl Fumarate (BG00012)1318.1 cells per cubic millimeter (cells/mm^3)544 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-44.8 cells per cubic millimeter (cells/mm^3)383.55 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-167.0 cells per cubic millimeter (cells/mm^3)482.86 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-284.3 cells per cubic millimeter (cells/mm^3)527.58 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-446.7 cells per cubic millimeter (cells/mm^3)542.06 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-545.5 cells per cubic millimeter (cells/mm^3)550.87 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-580.2 cells per cubic millimeter (cells/mm^3)551.52 (Standard Deviation)218
Dimethyl Fumarate (BG00012)879.0 cells per cubic millimeter (cells/mm^3)400.71 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-27.4 cells per cubic millimeter (cells/mm^3)256.21 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-95.4 cells per cubic millimeter (cells/mm^3)318.07 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-176.8 cells per cubic millimeter (cells/mm^3)353.52 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-269.8 cells per cubic millimeter (cells/mm^3)360.92 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-329.7 cells per cubic millimeter (cells/mm^3)374.66 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-352.6 cells per cubic millimeter (cells/mm^3)380.77 (Standard Deviation)218
Dimethyl Fumarate (BG00012)419.5 cells per cubic millimeter (cells/mm^3)203.76 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-14.2 cells per cubic millimeter (cells/mm^3)147.21 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-65.3 cells per cubic millimeter (cells/mm^3)181.65 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-100.4 cells per cubic millimeter (cells/mm^3)193.28 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-170.2 cells per cubic millimeter (cells/mm^3)201.14 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-201.4 cells per cubic millimeter (cells/mm^3)203.1 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-214.9 cells per cubic millimeter (cells/mm^3)203.62 (Standard Deviation)218

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

GroupValueIntervalNumber analysed
Dimethyl Fumarate (BG00012)632.6 cells/mm^3305.86 (Standard Deviation)218
Dimethyl Fumarate (BG00012)15.2 cells/mm^3241.73 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-26.5 cells/mm^3241.47 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-53.4 cells/mm^3246.22 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-100.4 cells/mm^3263.58 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-106.8 cells/mm^3308.03 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-125.9 cells/mm^3273.26 (Standard Deviation)218
Dimethyl Fumarate (BG00012)22.9 cells/mm^325.64 (Standard Deviation)218
Dimethyl Fumarate (BG00012)3.9 cells/mm^321.83 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-2.2 cells/mm^324.46 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-3.4 cells/mm^323.53 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-5.8 cells/mm^324.72 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-7.9 cells/mm^327.32 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-7.7 cells/mm^324.92 (Standard Deviation)218
Dimethyl Fumarate (BG00012)275.4 cells/mm^3158.04 (Standard Deviation)218
Dimethyl Fumarate (BG00012)18.2 cells/mm^3118.67 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-21.7 cells/mm^3126.38 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-50.8 cells/mm^3132.08 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-91.8 cells/mm^3142.99 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-99.3 cells/mm^3162.79 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-114.3 cells/mm^3152.39 (Standard Deviation)218
Dimethyl Fumarate (BG00012)10.4 cells/mm^36.52 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.6 cells/mm^36.09 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.2 cells/mm^36.87 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-2.1 cells/mm^36.63 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-3.5 cells/mm^36.47 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-3.8 cells/mm^36.82 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-4.0 cells/mm^36.5 (Standard Deviation)218
Dimethyl Fumarate (BG00012)1.1 cells/mm^31.33 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.0 cells/mm^31.01 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.2 cells/mm^31.5 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.0 cells/mm^31.36 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.4 cells/mm^31.33 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.4 cells/mm^30.96 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.3 cells/mm^31.06 (Standard Deviation)218
Dimethyl Fumarate (BG00012)4.8 cells/mm^34.83 (Standard Deviation)218
Dimethyl Fumarate (BG00012)1.2 cells/mm^35.36 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.4 cells/mm^36.13 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.5 cells/mm^36.54 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.6 cells/mm^36.84 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.3 cells/mm^36.57 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.2 cells/mm^35.14 (Standard Deviation)218
Dimethyl Fumarate (BG00012)17.3 cells/mm^312.77 (Standard Deviation)218
Dimethyl Fumarate (BG00012)2.5 cells/mm^311.63 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.3 cells/mm^312.81 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.6 cells/mm^312.1 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-3.2 cells/mm^313.54 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-4.1 cells/mm^312.07 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-4.2 cells/mm^311.62 (Standard Deviation)218
Dimethyl Fumarate (BG00012)64.6 cells/mm^332.45 (Standard Deviation)218
Dimethyl Fumarate (BG00012)1.4 cells/mm^327.95 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-5.1 cells/mm^338.57 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-11.7 cells/mm^331.71 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-26.0 cells/mm^330.09 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-33.6 cells/mm^336.39 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-30.1 cells/mm^338.57 (Standard Deviation)218
Dimethyl Fumarate (BG00012)81.2 cells/mm^363.34 (Standard Deviation)218
Dimethyl Fumarate (BG00012)2.5 cells/mm^346.91 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-5.5 cells/mm^367.56 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-18.2 cells/mm^359.58 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-38.1 cells/mm^357.42 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-48.3 cells/mm^363.85 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-49.3 cells/mm^359.85 (Standard Deviation)218
Dimethyl Fumarate (BG00012)433.4 cells/mm^3220.05 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-21.0 cells/mm^3185.07 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-68.0 cells/mm^3196.02 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-105.3 cells/mm^3206.11 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-204.2 cells/mm^3220.61 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-235.7 cells/mm^3221.44 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-231.1 cells/mm^3225.25 (Standard Deviation)218
Dimethyl Fumarate (BG00012)59.9 cells/mm^360.38 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-9.6 cells/mm^345.92 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-16.9 cells/mm^341.72 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-22.0 cells/mm^348.1 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-39.2 cells/mm^350 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-44.3 cells/mm^355.66 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-45.9 cells/mm^353.78 (Standard Deviation)218
Dimethyl Fumarate (BG00012)12.0 cells/mm^323.21 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.8 cells/mm^312.66 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.1 cells/mm^312.58 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.0 cells/mm^312.43 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.6 cells/mm^317.42 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.9 cells/mm^319.2 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-4.7 cells/mm^318.75 (Standard Deviation)218
Dimethyl Fumarate (BG00012)101.4 cells/mm^391.95 (Standard Deviation)218
Dimethyl Fumarate (BG00012)1.7 cells/mm^363.49 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-15.9 cells/mm^367.93 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-15.2 cells/mm^380.78 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-42.8 cells/mm^374.14 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-55.6 cells/mm^378.88 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-50.9 cells/mm^382.46 (Standard Deviation)218
Dimethyl Fumarate (BG00012)179.7 cells/mm^386.21 (Standard Deviation)218
Dimethyl Fumarate (BG00012)10.9 cells/mm^387.56 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-33.2 cells/mm^388.53 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-55.2 cells/mm^390.59 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-81.7 cells/mm^3106.78 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-98.1 cells/mm^3111.77 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-118.5 cells/mm^3100.25 (Standard Deviation)218
Dimethyl Fumarate (BG00012)129.0 cells/mm^392.24 (Standard Deviation)218
Dimethyl Fumarate (BG00012)7.6 cells/mm^382.42 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-22.8 cells/mm^388.05 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-41.0 cells/mm^385.82 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-69.9 cells/mm^390.17 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-80.3 cells/mm^396.19 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-90.3 cells/mm^397.07 (Standard Deviation)218
Dimethyl Fumarate (BG00012)56.1 cells/mm^328.88 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.6 cells/mm^326.13 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-7.1 cells/mm^327.32 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-12.7 cells/mm^325.81 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-20.3 cells/mm^328.31 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-25.8 cells/mm^331.5 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-25.1 cells/mm^329.73 (Standard Deviation)218
Dimethyl Fumarate (BG00012)617.7 cells/mm^3256.07 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-6.2 cells/mm^3233.54 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-100.9 cells/mm^3252.99 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-157.7 cells/mm^3269.36 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-287.7 cells/mm^3291.97 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-335.0 cells/mm^3299.23 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-349.9 cells/mm^3289.24 (Standard Deviation)218
Dimethyl Fumarate (BG00012)187.5 cells/mm^3126.58 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-4.7 cells/mm^397.59 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-40.9 cells/mm^3109.49 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-64.0 cells/mm^3118.89 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-108.6 cells/mm^3119.94 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-124.9 cells/mm^3126.3 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-136.3 cells/mm^3129.68 (Standard Deviation)218
Dimethyl Fumarate (BG00012)400.9 cells/mm^3261.16 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-10.5 cells/mm^3175.86 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-16.4 cells/mm^3169.6 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-11.8 cells/mm^3177.35 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-31.7 cells/mm^3190.17 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-29.3 cells/mm^3204.15 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-34.4 cells/mm^3197.57 (Standard Deviation)218
Dimethyl Fumarate (BG00012)416.7 cells/mm^3268.35 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-8.6 cells/mm^3177.59 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-15.6 cells/mm^3173.25 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-10.2 cells/mm^3185.67 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-33.6 cells/mm^3193.78 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-30.2 cells/mm^3214.46 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-37.0 cells/mm^3206.1 (Standard Deviation)218
Dimethyl Fumarate (BG00012)160.1 cells/mm^3108.32 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-11.6 cells/mm^379.05 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-12.4 cells/mm^375.66 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-22.0 cells/mm^373.23 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-41.3 cells/mm^377.22 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-49.0 cells/mm^388.78 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-50.9 cells/mm^380.43 (Standard Deviation)218
Dimethyl Fumarate (BG00012)258.0 cells/mm^3150.73 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-11.7 cells/mm^3118.68 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-28.3 cells/mm^3118.33 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-39.7 cells/mm^3131.27 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-82.4 cells/mm^3134 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-106.1 cells/mm^3139.47 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-103.4 cells/mm^3138.84 (Standard Deviation)218
Dimethyl Fumarate (BG00012)15.8 cells/mm^313.44 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.1 cells/mm^311.9 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.4 cells/mm^312.19 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.7 cells/mm^39.84 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.4 cells/mm^311.87 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.1 cells/mm^312.07 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.1 cells/mm^310.25 (Standard Deviation)218
Dimethyl Fumarate (BG00012)71.5 cells/mm^336.6 (Standard Deviation)218
Dimethyl Fumarate (BG00012)1.0 cells/mm^334.31 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-7.3 cells/mm^335.01 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-13.3 cells/mm^332.12 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-20.0 cells/mm^336.77 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-25.7 cells/mm^340.18 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-24.4 cells/mm^336.09 (Standard Deviation)218
Dimethyl Fumarate (BG00012)327.2 cells/mm^3168.48 (Standard Deviation)218
Dimethyl Fumarate (BG00012)16.6 cells/mm^3158.45 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-4.4 cells/mm^3167.36 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-17.6 cells/mm^3167.8 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-58.3 cells/mm^3174.97 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-97.2 cells/mm^3199.08 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-98.6 cells/mm^3186.01 (Standard Deviation)218
Dimethyl Fumarate (BG00012)329.5 cells/mm^3153.17 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-14.7 cells/mm^3127.21 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-65.4 cells/mm^3147.25 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-102.1 cells/mm^3149.63 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-159.2 cells/mm^3172.24 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-183.0 cells/mm^3177.4 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-187.4 cells/mm^3172.19 (Standard Deviation)218
Dimethyl Fumarate (BG00012)61.9 cells/mm^340.76 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.5 cells/mm^337.46 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-7.3 cells/mm^339.1 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.1 cells/mm^345.74 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-24.6 cells/mm^342.79 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-35.1 cells/mm^339.56 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-30.1 cells/mm^339.12 (Standard Deviation)218
Dimethyl Fumarate (BG00012)562.7 cells/mm^3289.42 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.6 cells/mm^3211.18 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-31.5 cells/mm^3227.69 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-54.0 cells/mm^3210.95 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-96.7 cells/mm^3241.83 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-97.7 cells/mm^3267.45 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-125.2 cells/mm^3242.46 (Standard Deviation)218

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

GroupValueIntervalNumber analysed
Dimethyl Fumarate (BG00012)9.4 cells/mm^39.93 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.2 cells/mm^37.98 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.4 cells/mm^38.73 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.4 cells/mm^39.09 (Standard Deviation)218
Dimethyl Fumarate (BG00012)3.6 cells/mm^310.16 (Standard Deviation)218
Dimethyl Fumarate (BG00012)2.8 cells/mm^39.53 (Standard Deviation)218
Dimethyl Fumarate (BG00012)5.7 cells/mm^313.53 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.26 cells/mm^30.289 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.02 cells/mm^30.367 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.12 cells/mm^30.291 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.15 cells/mm^30.288 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.21 cells/mm^30.297 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.21 cells/mm^30.327 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.19 cells/mm^30.318 (Standard Deviation)218
Dimethyl Fumarate (BG00012)37.8 cells/mm^336.96 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-8.9 cells/mm^326.18 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-12.4 cells/mm^329.27 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-12.1 cells/mm^329.13 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-17.6 cells/mm^331.39 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-19.6 cells/mm^331.61 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-13.4 cells/mm^334.89 (Standard Deviation)218
Dimethyl Fumarate (BG00012)50.4 cells/mm^356.97 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-8.7 cells/mm^332.2 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-17.7 cells/mm^344.42 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-23.1 cells/mm^344.76 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-29.5 cells/mm^349.95 (Standard Deviation)218
Dimethyl Fumarate (BG00012)49.95 cells/mm^332.64 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-27.4 cells/mm^338.33 (Standard Deviation)218
Dimethyl Fumarate (BG00012)197.2 cells/mm^3140.48 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-21.5 cells/mm^382.43 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-37.2 cells/mm^395.32 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-43.1 cells/mm^399.72 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-45.7 cells/mm^3114.46 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-54.0 cells/mm^394.94 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-35.6 cells/mm^3107.79 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.63 cells/mm^30.668 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.02 cells/mm^30.816 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.11 cells/mm^30.643 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.18 cells/mm^30.647 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.34 cells/mm^30.649 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.33 cells/mm^30.786 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.38 cells/mm^30.633 (Standard Deviation)218
Dimethyl Fumarate (BG00012)13.6 cells/mm^313.61 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.3 cells/mm^311.44 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.6 cells/mm^312.97 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.7 cells/mm^313.41 (Standard Deviation)218
Dimethyl Fumarate (BG00012)5.8 cells/mm^315.6 (Standard Deviation)218
Dimethyl Fumarate (BG00012)4.2 cells/mm^313.2 (Standard Deviation)218
Dimethyl Fumarate (BG00012)7.3 cells/mm^318.56 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.91 cells/mm^31.104 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.04 cells/mm^31.12 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.21 cells/mm^31.062 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.31 cells/mm^31.024 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.46 cells/mm^31.106 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.46 cells/mm^31.228 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.50 cells/mm^31.084 (Standard Deviation)218

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

GroupValueIntervalNumber analysed
Dimethyl Fumarate (BG00012)14.0 cells/mm^38.94 (Standard Deviation)218
Dimethyl Fumarate (BG00012)1.8 cells/mm^36.4 (Standard Deviation)218
Dimethyl Fumarate (BG00012)1.8 cells/mm^37.07 (Standard Deviation)218
Dimethyl Fumarate (BG00012)1.3 cells/mm^37.26 (Standard Deviation)218
Dimethyl Fumarate (BG00012)2.1 cells/mm^38.57 (Standard Deviation)218
Dimethyl Fumarate (BG00012)2.3 cells/mm^39.73 (Standard Deviation)218
Dimethyl Fumarate (BG00012)2.1 cells/mm^38.55 (Standard Deviation)218
Dimethyl Fumarate (BG00012)192.9 cells/mm^3130.45 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-2.0 cells/mm^3102.59 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-17.2 cells/mm^3102.92 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-31.4 cells/mm^392.14 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-50.7 cells/mm^3101.34 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-61.1 cells/mm^3102.96 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-68.5 cells/mm^3129.83 (Standard Deviation)218
Dimethyl Fumarate (BG00012)301.4 cells/mm^3153.48 (Standard Deviation)218
Dimethyl Fumarate (BG00012)7.5 cells/mm^3182.11 (Standard Deviation)218
Dimethyl Fumarate (BG00012)6.0 cells/mm^3165.07 (Standard Deviation)218
Dimethyl Fumarate (BG00012)9.3 cells/mm^3197.84 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-8.7 cells/mm^3151.23 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.5 cells/mm^3163.62 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.8 cells/mm^3153.24 (Standard Deviation)218
Dimethyl Fumarate (BG00012)24.96 cells/mm^316.315 (Standard Deviation)218
Dimethyl Fumarate (BG00012)1.46 cells/mm^318.111 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.61 cells/mm^317.67 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.23 cells/mm^317.932 (Standard Deviation)218
Dimethyl Fumarate (BG00012)3.02 cells/mm^317.882 (Standard Deviation)218
Dimethyl Fumarate (BG00012)3.63 cells/mm^318.779 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-6.20 cells/mm^317.78 (Standard Deviation)218
Dimethyl Fumarate (BG00012)32.0 cells/mm^322.88 (Standard Deviation)218
Dimethyl Fumarate (BG00012)2.2 cells/mm^329.82 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.9 cells/mm^330.14 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-10.8 cells/mm^323.82 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-6.9 cells/mm^327.65 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-10.6 cells/mm^324.24 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-9.2 cells/mm^324.37 (Standard Deviation)218
Dimethyl Fumarate (BG00012)6.52 cells/mm^34.617 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.00 cells/mm^35.168 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.30 cells/mm^36.427 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.86 cells/mm^34.575 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.69 cells/mm^34.138 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.80 cells/mm^34.086 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-2.22 cells/mm^34.509 (Standard Deviation)218
Dimethyl Fumarate (BG00012)35.4 cells/mm^319.92 (Standard Deviation)218
Dimethyl Fumarate (BG00012)2.0 cells/mm^322.35 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.3 cells/mm^321.68 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.9 cells/mm^321.07 (Standard Deviation)218
Dimethyl Fumarate (BG00012)1.6 cells/mm^321.89 (Standard Deviation)218
Dimethyl Fumarate (BG00012)2.5 cells/mm^322.19 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-9.1 cells/mm^322.77 (Standard Deviation)218
Dimethyl Fumarate (BG00012)374.6 cells/mm^3179.05 (Standard Deviation)218
Dimethyl Fumarate (BG00012)26.9 cells/mm^3201.63 (Standard Deviation)218
Dimethyl Fumarate (BG00012)12.6 cells/mm^3189.91 (Standard Deviation)218
Dimethyl Fumarate (BG00012)14.4 cells/mm^3211.67 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-19.3 cells/mm^3174.82 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-21.7 cells/mm^3186.41 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-19.2 cells/mm^3175.1 (Standard Deviation)218

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

GroupValueIntervalNumber analysed
Dimethyl Fumarate (BG00012)3.340 cells/mm^32.7365 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.090 cells/mm^32.235 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.356 cells/mm^31.9676 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.729 cells/mm^32.157 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.134 cells/mm^32.4239 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.511 cells/mm^32.5109 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.222 cells/mm^32.3513 (Standard Deviation)218
Dimethyl Fumarate (BG00012)6.166 cells/mm^34.6199 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.493 cells/mm^32.8636 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.264 cells/mm^33.0735 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.345 cells/mm^33.3647 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.650 cells/mm^32.7202 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.922 cells/mm^34.1425 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.306 cells/mm^34.3931 (Standard Deviation)218
Dimethyl Fumarate (BG00012)4.518 cells/mm^33.0417 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.050 cells/mm^32.5996 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.295 cells/mm^32.6287 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.851 cells/mm^32.859 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.019 cells/mm^32.812 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.804 cells/mm^32.6448 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.369 cells/mm^33.0958 (Standard Deviation)218
Dimethyl Fumarate (BG00012)8.795 cells/mm^35.906 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.360 cells/mm^33.6006 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.285 cells/mm^34.2645 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.543 cells/mm^33.7393 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.964 cells/mm^33.6799 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-2.035 cells/mm^35.3349 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.497 cells/mm^35.3126 (Standard Deviation)218
Dimethyl Fumarate (BG00012)1.244 cells/mm^31.5863 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.115 cells/mm^31.9918 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.131 cells/mm^31.9097 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.470 cells/mm^32.3445 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.165 cells/mm^32.0104 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.419 cells/mm^32.5007 (Standard Deviation)218
Dimethyl Fumarate (BG00012)1.693 cells/mm^34.2412 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.455 cells/mm^30.5309 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.239 cells/mm^31.3557 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.032 cells/mm^30.6448 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.301 cells/mm^30.8912 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.289 cells/mm^30.8526 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.911 cells/mm^31.3499 (Standard Deviation)218
Dimethyl Fumarate (BG00012)1.457 cells/mm^32.1499 (Standard Deviation)218
Dimethyl Fumarate (BG00012)1.075 cells/mm^31.177 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.000 cells/mm^31.3599 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.040 cells/mm^31.3593 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.373 cells/mm^31.7166 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.228 cells/mm^31.498 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.333 cells/mm^31.8786 (Standard Deviation)218
Dimethyl Fumarate (BG00012)1.255 cells/mm^32.9557 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.155 cells/mm^30.2356 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.113 cells/mm^30.6972 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.027 cells/mm^30.3641 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.064 cells/mm^30.3641 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.254 cells/mm^30.8682 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.270 cells/mm^30.6113 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.680 cells/mm^31.2842 (Standard Deviation)218
Dimethyl Fumarate (BG00012)5.177 cells/mm^34.5225 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.062 cells/mm^33.4662 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.149 cells/mm^34.0713 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.069 cells/mm^34.0822 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.448 cells/mm^33.628 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.837 cells/mm^33.8603 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.840 cells/mm^35.0951 (Standard Deviation)218
Dimethyl Fumarate (BG00012)1.180 cells/mm^31.4533 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.081 cells/mm^31.2797 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.227 cells/mm^31.1579 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.2622 cells/mm^31.2601 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.525 cells/mm^31.0201 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.547 cells/mm^31.2886 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.248 cells/mm^31.186 (Standard Deviation)218
Dimethyl Fumarate (BG00012)7.053 cells/mm^35.6653 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.105 cells/mm^34.4131 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.056 cells/mm^34.6541 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.012 cells/mm^34.9241 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.015 cells/mm^34.6456 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-2.140 cells/mm^34.7723 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.946 cells/mm^35.6985 (Standard Deviation)218
Dimethyl Fumarate (BG00012)1.879 cells/mm^31.7964 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.218 cells/mm^31.6838 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.318 cells/mm^31.7272 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.115 cells/mm^31.7354 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.461 cells/mm^31.4512 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.803 cells/mm^31.8525 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.315 cells/mm^32.051 (Standard Deviation)218
Dimethyl Fumarate (BG00012)1.261 cells/mm^31.119 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.150 cells/mm^31.0429 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.113 cells/mm^31.2168 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.370 cells/mm^31.0594 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.170 cells/mm^31.1551 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.376 cells/mm^31.092 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.281 cells/mm^34.7206 (Standard Deviation)218
Dimethyl Fumarate (BG00012)1.107 cells/mm^31.2924 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.222 cells/mm^31.2163 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.189 cells/mm^31.3377 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.553 cells/mm^31.3754 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.032 cells/mm^31.317 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.195 cells/mm^31.3334 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.786 cells/mm^31.3454 (Standard Deviation)218
Dimethyl Fumarate (BG00012)1.406 cells/mm^31.2437 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.128 cells/mm^31.2649 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.141 cells/mm^31.4642 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.412 cells/mm^31.3656 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.136 cells/mm^31.3059 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.266 cells/mm^31.4005 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.325 cells/mm^31.7918 (Standard Deviation)218
Dimethyl Fumarate (BG00012)1.376 cells/mm^31.8963 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.180 cells/mm^32.0821 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.269 cells/mm^31.984 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.795 cells/mm^32.2486 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.416 cells/mm^32.3613 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.284 cells/mm^32.4433 (Standard Deviation)218
Dimethyl Fumarate (BG00012)1.836 cells/mm^32.7709 (Standard Deviation)218

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

GroupValueIntervalNumber analysed
Dimethyl Fumarate (BG00012)99.33 cells/mm^32.106 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.34 cells/mm^32.497 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.44 cells/mm^32.203 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.17 cells/mm^32.534 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.19 cells/mm^32.549 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.43 cells/mm^311.406 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.14 cells/mm^37.751 (Standard Deviation)218
Dimethyl Fumarate (BG00012)99.90 cells/mm^30.312 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.05 cells/mm^30.319 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.07 cells/mm^30.327 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.06 cells/mm^30.321 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.02 cells/mm^30.633 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.29 cells/mm^39.76 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.53 cells/mm^37.41 (Standard Deviation)218
Dimethyl Fumarate (BG00012)96.85 cells/mm^33.089 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.47 cells/mm^33.63 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.59 cells/mm^33.532 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.59 cells/mm^33.71 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.38 cells/mm^33.963 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.55 cells/mm^310.918 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-2.31 cells/mm^38.402 (Standard Deviation)218
Dimethyl Fumarate (BG00012)99.81 cells/mm^30.933 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.04 cells/mm^30.867 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.02 cells/mm^31.573 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.10 cells/mm^31.25 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.01 cells/mm^31.477 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.27 cells/mm^310.857 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.84 cells/mm^37.813 (Standard Deviation)218
Dimethyl Fumarate (BG00012)98.24 cells/mm^31.87 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.04 cells/mm^32.227 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.07 cells/mm^32.649 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.26 cells/mm^32.604 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.35 cells/mm^32.519 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.99 cells/mm^310.532 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-2.56 cells/mm^38.696 (Standard Deviation)218
Dimethyl Fumarate (BG00012)98.00 cells/mm^32.303 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.29 cells/mm^33.241 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.92 cells/mm^32.416 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.77 cells/mm^32.539 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.40 cells/mm^33.046 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.36 cells/mm^37.843 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.52 cells/mm^37.711 (Standard Deviation)218
Dimethyl Fumarate (BG00012)97.80 cells/mm^35.352 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.83 cells/mm^36.672 (Standard Deviation)218
Dimethyl Fumarate (BG00012)1.23 cells/mm^35.675 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.55 cells/mm^36.113 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.35 cells/mm^39.22 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-2.88 cells/mm^318.513 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.42 cells/mm^310.736 (Standard Deviation)218
Dimethyl Fumarate (BG00012)99.87 cells/mm^30.679 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.50 cells/mm^37.105 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.00 cells/mm^30.642 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.01 cells/mm^30.486 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.01 cells/mm^30.663 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.07 cells/mm^30.744 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.04 cells/mm^30.964 (Standard Deviation)218
Dimethyl Fumarate (BG00012)91.23 cells/mm^34.427 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.45 cells/mm^36.909 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.11 cells/mm^32.055 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.06 cells/mm^31.93 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.12 cells/mm^32.209 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.32 cells/mm^34.256 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.02 cells/mm^32.935 (Standard Deviation)218
Dimethyl Fumarate (BG00012)86.79 cells/mm^35.369 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.23 cells/mm^38.274 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.38 cells/mm^35.6 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.85 cells/mm^35.9 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.07 cells/mm^36.051 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.46 cells/mm^38.264 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.25 cells/mm^36.561 (Standard Deviation)218
Dimethyl Fumarate (BG00012)99.77 cells/mm^30.771 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.42 cells/mm^37.185 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.12 cells/mm^30.874 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.03 cells/mm^31.252 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.00 cells/mm^31.162 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.06 cells/mm^31.532 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.23 cells/mm^31.53 (Standard Deviation)218
Dimethyl Fumarate (BG00012)91.29 cells/mm^34.715 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.31 cells/mm^37.26 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.03 cells/mm^35.899 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.44 cells/mm^32.989 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.01 cells/mm^33.237 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.75 cells/mm^35.045 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-1.10 cells/mm^35.739 (Standard Deviation)218
Dimethyl Fumarate (BG00012)88.77 cells/mm^38.126 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.82 cells/mm^310.895 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.96 cells/mm^310.161 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.82 cells/mm^310.35 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.98 cells/mm^39.793 (Standard Deviation)218
Dimethyl Fumarate (BG00012)3.87 cells/mm^39.683 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.69 cells/mm^310.594 (Standard Deviation)218
Dimethyl Fumarate (BG00012)5.61 cells/mm^37.277 (Standard Deviation)218
Dimethyl Fumarate (BG00012)4.43 cells/mm^39.345 (Standard Deviation)218
Dimethyl Fumarate (BG00012)1.17 cells/mm^34.892 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.27 cells/mm^34.137 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.67 cells/mm^310.365 (Standard Deviation)218
Dimethyl Fumarate (BG00012)-0.29 cells/mm^312.678 (Standard Deviation)218
Dimethyl Fumarate (BG00012)0.92 cells/mm^310.291 (Standard Deviation)218

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Dimethyl Fumarate (BG00012)21826 (11.9%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • 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

    Immune response
  • 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

    Thinking and memoryImmune response
  • 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

    Thinking and memoryImmune response
  • 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

    Immune response
  • 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

    Thinking and memoryImmune response
  • 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

    Immune response
  • The primary endpoint is the change in lymphocyte subset counts for up to 48 weeks.

    Immune response

Other measures (5)

  • Change From Baseline in Immunoglobulin A (IgA) up to 48 Weeks

    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48

  • Change From Baseline in Immunoglobulin M (IgM) up to 48 Weeks

    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48

  • 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

  • The secondary endpoints are the changes in IgG isotypes and ALCs for up to 48 weeks.

Who could take part

Relapsing MS · 18 to 65

Show the full criteria

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/Exclusion criteria may apply

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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Related trials

History

    1. Started

      Aug 2015

    2. Main results due

      Apr 2017

    3. Finished

      Apr 2018

    4. Results posted

      Jun 2019

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