Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subject
An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Dimethyl fumarate
Kelch-like ECH-associated protein 1 inhibitor
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
| Group | Value | Interval | Number 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
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Dimethyl Fumarate (BG00012) | 632.6 cells/mm^3 | 305.86 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 15.2 cells/mm^3 | 241.73 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -26.5 cells/mm^3 | 241.47 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -53.4 cells/mm^3 | 246.22 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -100.4 cells/mm^3 | 263.58 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -106.8 cells/mm^3 | 308.03 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -125.9 cells/mm^3 | 273.26 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 22.9 cells/mm^3 | 25.64 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 3.9 cells/mm^3 | 21.83 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -2.2 cells/mm^3 | 24.46 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -3.4 cells/mm^3 | 23.53 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -5.8 cells/mm^3 | 24.72 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -7.9 cells/mm^3 | 27.32 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -7.7 cells/mm^3 | 24.92 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 275.4 cells/mm^3 | 158.04 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 18.2 cells/mm^3 | 118.67 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -21.7 cells/mm^3 | 126.38 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -50.8 cells/mm^3 | 132.08 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -91.8 cells/mm^3 | 142.99 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -99.3 cells/mm^3 | 162.79 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -114.3 cells/mm^3 | 152.39 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 10.4 cells/mm^3 | 6.52 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.6 cells/mm^3 | 6.09 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.2 cells/mm^3 | 6.87 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -2.1 cells/mm^3 | 6.63 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -3.5 cells/mm^3 | 6.47 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -3.8 cells/mm^3 | 6.82 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -4.0 cells/mm^3 | 6.5 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 1.1 cells/mm^3 | 1.33 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.0 cells/mm^3 | 1.01 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.2 cells/mm^3 | 1.5 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.0 cells/mm^3 | 1.36 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.4 cells/mm^3 | 1.33 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.4 cells/mm^3 | 0.96 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.3 cells/mm^3 | 1.06 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 4.8 cells/mm^3 | 4.83 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 1.2 cells/mm^3 | 5.36 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.4 cells/mm^3 | 6.13 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.5 cells/mm^3 | 6.54 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.6 cells/mm^3 | 6.84 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.3 cells/mm^3 | 6.57 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.2 cells/mm^3 | 5.14 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 17.3 cells/mm^3 | 12.77 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 2.5 cells/mm^3 | 11.63 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.3 cells/mm^3 | 12.81 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.6 cells/mm^3 | 12.1 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -3.2 cells/mm^3 | 13.54 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -4.1 cells/mm^3 | 12.07 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -4.2 cells/mm^3 | 11.62 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 64.6 cells/mm^3 | 32.45 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 1.4 cells/mm^3 | 27.95 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -5.1 cells/mm^3 | 38.57 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -11.7 cells/mm^3 | 31.71 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -26.0 cells/mm^3 | 30.09 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -33.6 cells/mm^3 | 36.39 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -30.1 cells/mm^3 | 38.57 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 81.2 cells/mm^3 | 63.34 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 2.5 cells/mm^3 | 46.91 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -5.5 cells/mm^3 | 67.56 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -18.2 cells/mm^3 | 59.58 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -38.1 cells/mm^3 | 57.42 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -48.3 cells/mm^3 | 63.85 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -49.3 cells/mm^3 | 59.85 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 433.4 cells/mm^3 | 220.05 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -21.0 cells/mm^3 | 185.07 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -68.0 cells/mm^3 | 196.02 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -105.3 cells/mm^3 | 206.11 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -204.2 cells/mm^3 | 220.61 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -235.7 cells/mm^3 | 221.44 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -231.1 cells/mm^3 | 225.25 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 59.9 cells/mm^3 | 60.38 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -9.6 cells/mm^3 | 45.92 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -16.9 cells/mm^3 | 41.72 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -22.0 cells/mm^3 | 48.1 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -39.2 cells/mm^3 | 50 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -44.3 cells/mm^3 | 55.66 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -45.9 cells/mm^3 | 53.78 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 12.0 cells/mm^3 | 23.21 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.8 cells/mm^3 | 12.66 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.1 cells/mm^3 | 12.58 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.0 cells/mm^3 | 12.43 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.6 cells/mm^3 | 17.42 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.9 cells/mm^3 | 19.2 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -4.7 cells/mm^3 | 18.75 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 101.4 cells/mm^3 | 91.95 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 1.7 cells/mm^3 | 63.49 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -15.9 cells/mm^3 | 67.93 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -15.2 cells/mm^3 | 80.78 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -42.8 cells/mm^3 | 74.14 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -55.6 cells/mm^3 | 78.88 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -50.9 cells/mm^3 | 82.46 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 179.7 cells/mm^3 | 86.21 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 10.9 cells/mm^3 | 87.56 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -33.2 cells/mm^3 | 88.53 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -55.2 cells/mm^3 | 90.59 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -81.7 cells/mm^3 | 106.78 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -98.1 cells/mm^3 | 111.77 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -118.5 cells/mm^3 | 100.25 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 129.0 cells/mm^3 | 92.24 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 7.6 cells/mm^3 | 82.42 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -22.8 cells/mm^3 | 88.05 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -41.0 cells/mm^3 | 85.82 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -69.9 cells/mm^3 | 90.17 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -80.3 cells/mm^3 | 96.19 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -90.3 cells/mm^3 | 97.07 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 56.1 cells/mm^3 | 28.88 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.6 cells/mm^3 | 26.13 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -7.1 cells/mm^3 | 27.32 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -12.7 cells/mm^3 | 25.81 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -20.3 cells/mm^3 | 28.31 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -25.8 cells/mm^3 | 31.5 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -25.1 cells/mm^3 | 29.73 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 617.7 cells/mm^3 | 256.07 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -6.2 cells/mm^3 | 233.54 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -100.9 cells/mm^3 | 252.99 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -157.7 cells/mm^3 | 269.36 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -287.7 cells/mm^3 | 291.97 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -335.0 cells/mm^3 | 299.23 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -349.9 cells/mm^3 | 289.24 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 187.5 cells/mm^3 | 126.58 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -4.7 cells/mm^3 | 97.59 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -40.9 cells/mm^3 | 109.49 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -64.0 cells/mm^3 | 118.89 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -108.6 cells/mm^3 | 119.94 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -124.9 cells/mm^3 | 126.3 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -136.3 cells/mm^3 | 129.68 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 400.9 cells/mm^3 | 261.16 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -10.5 cells/mm^3 | 175.86 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -16.4 cells/mm^3 | 169.6 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -11.8 cells/mm^3 | 177.35 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -31.7 cells/mm^3 | 190.17 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -29.3 cells/mm^3 | 204.15 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -34.4 cells/mm^3 | 197.57 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 416.7 cells/mm^3 | 268.35 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -8.6 cells/mm^3 | 177.59 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -15.6 cells/mm^3 | 173.25 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -10.2 cells/mm^3 | 185.67 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -33.6 cells/mm^3 | 193.78 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -30.2 cells/mm^3 | 214.46 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -37.0 cells/mm^3 | 206.1 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 160.1 cells/mm^3 | 108.32 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -11.6 cells/mm^3 | 79.05 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -12.4 cells/mm^3 | 75.66 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -22.0 cells/mm^3 | 73.23 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -41.3 cells/mm^3 | 77.22 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -49.0 cells/mm^3 | 88.78 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -50.9 cells/mm^3 | 80.43 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 258.0 cells/mm^3 | 150.73 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -11.7 cells/mm^3 | 118.68 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -28.3 cells/mm^3 | 118.33 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -39.7 cells/mm^3 | 131.27 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -82.4 cells/mm^3 | 134 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -106.1 cells/mm^3 | 139.47 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -103.4 cells/mm^3 | 138.84 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 15.8 cells/mm^3 | 13.44 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.1 cells/mm^3 | 11.9 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.4 cells/mm^3 | 12.19 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.7 cells/mm^3 | 9.84 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.4 cells/mm^3 | 11.87 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.1 cells/mm^3 | 12.07 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.1 cells/mm^3 | 10.25 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 71.5 cells/mm^3 | 36.6 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 1.0 cells/mm^3 | 34.31 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -7.3 cells/mm^3 | 35.01 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -13.3 cells/mm^3 | 32.12 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -20.0 cells/mm^3 | 36.77 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -25.7 cells/mm^3 | 40.18 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -24.4 cells/mm^3 | 36.09 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 327.2 cells/mm^3 | 168.48 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 16.6 cells/mm^3 | 158.45 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -4.4 cells/mm^3 | 167.36 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -17.6 cells/mm^3 | 167.8 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -58.3 cells/mm^3 | 174.97 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -97.2 cells/mm^3 | 199.08 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -98.6 cells/mm^3 | 186.01 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 329.5 cells/mm^3 | 153.17 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -14.7 cells/mm^3 | 127.21 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -65.4 cells/mm^3 | 147.25 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -102.1 cells/mm^3 | 149.63 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -159.2 cells/mm^3 | 172.24 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -183.0 cells/mm^3 | 177.4 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -187.4 cells/mm^3 | 172.19 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 61.9 cells/mm^3 | 40.76 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.5 cells/mm^3 | 37.46 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -7.3 cells/mm^3 | 39.1 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.1 cells/mm^3 | 45.74 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -24.6 cells/mm^3 | 42.79 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -35.1 cells/mm^3 | 39.56 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -30.1 cells/mm^3 | 39.12 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 562.7 cells/mm^3 | 289.42 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.6 cells/mm^3 | 211.18 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -31.5 cells/mm^3 | 227.69 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -54.0 cells/mm^3 | 210.95 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -96.7 cells/mm^3 | 241.83 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -97.7 cells/mm^3 | 267.45 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -125.2 cells/mm^3 | 242.46 (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
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Dimethyl Fumarate (BG00012) | 9.4 cells/mm^3 | 9.93 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.2 cells/mm^3 | 7.98 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.4 cells/mm^3 | 8.73 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.4 cells/mm^3 | 9.09 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 3.6 cells/mm^3 | 10.16 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 2.8 cells/mm^3 | 9.53 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 5.7 cells/mm^3 | 13.53 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.26 cells/mm^3 | 0.289 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.02 cells/mm^3 | 0.367 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.12 cells/mm^3 | 0.291 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.15 cells/mm^3 | 0.288 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.21 cells/mm^3 | 0.297 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.21 cells/mm^3 | 0.327 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.19 cells/mm^3 | 0.318 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 37.8 cells/mm^3 | 36.96 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -8.9 cells/mm^3 | 26.18 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -12.4 cells/mm^3 | 29.27 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -12.1 cells/mm^3 | 29.13 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -17.6 cells/mm^3 | 31.39 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -19.6 cells/mm^3 | 31.61 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -13.4 cells/mm^3 | 34.89 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 50.4 cells/mm^3 | 56.97 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -8.7 cells/mm^3 | 32.2 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -17.7 cells/mm^3 | 44.42 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -23.1 cells/mm^3 | 44.76 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -29.5 cells/mm^3 | 49.95 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 49.95 cells/mm^3 | 32.64 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -27.4 cells/mm^3 | 38.33 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 197.2 cells/mm^3 | 140.48 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -21.5 cells/mm^3 | 82.43 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -37.2 cells/mm^3 | 95.32 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -43.1 cells/mm^3 | 99.72 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -45.7 cells/mm^3 | 114.46 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -54.0 cells/mm^3 | 94.94 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -35.6 cells/mm^3 | 107.79 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.63 cells/mm^3 | 0.668 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.02 cells/mm^3 | 0.816 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.11 cells/mm^3 | 0.643 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.18 cells/mm^3 | 0.647 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.34 cells/mm^3 | 0.649 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.33 cells/mm^3 | 0.786 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.38 cells/mm^3 | 0.633 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 13.6 cells/mm^3 | 13.61 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.3 cells/mm^3 | 11.44 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.6 cells/mm^3 | 12.97 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.7 cells/mm^3 | 13.41 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 5.8 cells/mm^3 | 15.6 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 4.2 cells/mm^3 | 13.2 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 7.3 cells/mm^3 | 18.56 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.91 cells/mm^3 | 1.104 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.04 cells/mm^3 | 1.12 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.21 cells/mm^3 | 1.062 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.31 cells/mm^3 | 1.024 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.46 cells/mm^3 | 1.106 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.46 cells/mm^3 | 1.228 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.50 cells/mm^3 | 1.084 (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
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Dimethyl Fumarate (BG00012) | 14.0 cells/mm^3 | 8.94 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 1.8 cells/mm^3 | 6.4 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 1.8 cells/mm^3 | 7.07 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 1.3 cells/mm^3 | 7.26 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 2.1 cells/mm^3 | 8.57 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 2.3 cells/mm^3 | 9.73 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 2.1 cells/mm^3 | 8.55 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 192.9 cells/mm^3 | 130.45 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -2.0 cells/mm^3 | 102.59 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -17.2 cells/mm^3 | 102.92 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -31.4 cells/mm^3 | 92.14 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -50.7 cells/mm^3 | 101.34 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -61.1 cells/mm^3 | 102.96 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -68.5 cells/mm^3 | 129.83 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 301.4 cells/mm^3 | 153.48 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 7.5 cells/mm^3 | 182.11 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 6.0 cells/mm^3 | 165.07 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 9.3 cells/mm^3 | 197.84 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -8.7 cells/mm^3 | 151.23 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.5 cells/mm^3 | 163.62 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.8 cells/mm^3 | 153.24 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 24.96 cells/mm^3 | 16.315 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 1.46 cells/mm^3 | 18.111 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.61 cells/mm^3 | 17.67 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.23 cells/mm^3 | 17.932 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 3.02 cells/mm^3 | 17.882 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 3.63 cells/mm^3 | 18.779 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -6.20 cells/mm^3 | 17.78 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 32.0 cells/mm^3 | 22.88 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 2.2 cells/mm^3 | 29.82 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.9 cells/mm^3 | 30.14 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -10.8 cells/mm^3 | 23.82 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -6.9 cells/mm^3 | 27.65 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -10.6 cells/mm^3 | 24.24 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -9.2 cells/mm^3 | 24.37 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 6.52 cells/mm^3 | 4.617 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.00 cells/mm^3 | 5.168 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.30 cells/mm^3 | 6.427 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.86 cells/mm^3 | 4.575 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.69 cells/mm^3 | 4.138 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.80 cells/mm^3 | 4.086 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -2.22 cells/mm^3 | 4.509 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 35.4 cells/mm^3 | 19.92 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 2.0 cells/mm^3 | 22.35 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.3 cells/mm^3 | 21.68 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.9 cells/mm^3 | 21.07 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 1.6 cells/mm^3 | 21.89 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 2.5 cells/mm^3 | 22.19 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -9.1 cells/mm^3 | 22.77 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 374.6 cells/mm^3 | 179.05 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 26.9 cells/mm^3 | 201.63 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 12.6 cells/mm^3 | 189.91 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 14.4 cells/mm^3 | 211.67 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -19.3 cells/mm^3 | 174.82 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -21.7 cells/mm^3 | 186.41 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -19.2 cells/mm^3 | 175.1 (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
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Dimethyl Fumarate (BG00012) | 3.340 cells/mm^3 | 2.7365 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.090 cells/mm^3 | 2.235 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.356 cells/mm^3 | 1.9676 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.729 cells/mm^3 | 2.157 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.134 cells/mm^3 | 2.4239 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.511 cells/mm^3 | 2.5109 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.222 cells/mm^3 | 2.3513 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 6.166 cells/mm^3 | 4.6199 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.493 cells/mm^3 | 2.8636 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.264 cells/mm^3 | 3.0735 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.345 cells/mm^3 | 3.3647 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.650 cells/mm^3 | 2.7202 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.922 cells/mm^3 | 4.1425 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.306 cells/mm^3 | 4.3931 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 4.518 cells/mm^3 | 3.0417 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.050 cells/mm^3 | 2.5996 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.295 cells/mm^3 | 2.6287 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.851 cells/mm^3 | 2.859 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.019 cells/mm^3 | 2.812 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.804 cells/mm^3 | 2.6448 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.369 cells/mm^3 | 3.0958 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 8.795 cells/mm^3 | 5.906 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.360 cells/mm^3 | 3.6006 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.285 cells/mm^3 | 4.2645 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.543 cells/mm^3 | 3.7393 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.964 cells/mm^3 | 3.6799 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -2.035 cells/mm^3 | 5.3349 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.497 cells/mm^3 | 5.3126 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 1.244 cells/mm^3 | 1.5863 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.115 cells/mm^3 | 1.9918 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.131 cells/mm^3 | 1.9097 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.470 cells/mm^3 | 2.3445 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.165 cells/mm^3 | 2.0104 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.419 cells/mm^3 | 2.5007 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 1.693 cells/mm^3 | 4.2412 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.455 cells/mm^3 | 0.5309 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.239 cells/mm^3 | 1.3557 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.032 cells/mm^3 | 0.6448 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.301 cells/mm^3 | 0.8912 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.289 cells/mm^3 | 0.8526 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.911 cells/mm^3 | 1.3499 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 1.457 cells/mm^3 | 2.1499 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 1.075 cells/mm^3 | 1.177 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.000 cells/mm^3 | 1.3599 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.040 cells/mm^3 | 1.3593 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.373 cells/mm^3 | 1.7166 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.228 cells/mm^3 | 1.498 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.333 cells/mm^3 | 1.8786 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 1.255 cells/mm^3 | 2.9557 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.155 cells/mm^3 | 0.2356 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.113 cells/mm^3 | 0.6972 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.027 cells/mm^3 | 0.3641 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.064 cells/mm^3 | 0.3641 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.254 cells/mm^3 | 0.8682 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.270 cells/mm^3 | 0.6113 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.680 cells/mm^3 | 1.2842 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 5.177 cells/mm^3 | 4.5225 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.062 cells/mm^3 | 3.4662 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.149 cells/mm^3 | 4.0713 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.069 cells/mm^3 | 4.0822 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.448 cells/mm^3 | 3.628 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.837 cells/mm^3 | 3.8603 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.840 cells/mm^3 | 5.0951 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 1.180 cells/mm^3 | 1.4533 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.081 cells/mm^3 | 1.2797 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.227 cells/mm^3 | 1.1579 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.2622 cells/mm^3 | 1.2601 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.525 cells/mm^3 | 1.0201 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.547 cells/mm^3 | 1.2886 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.248 cells/mm^3 | 1.186 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 7.053 cells/mm^3 | 5.6653 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.105 cells/mm^3 | 4.4131 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.056 cells/mm^3 | 4.6541 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.012 cells/mm^3 | 4.9241 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.015 cells/mm^3 | 4.6456 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -2.140 cells/mm^3 | 4.7723 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.946 cells/mm^3 | 5.6985 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 1.879 cells/mm^3 | 1.7964 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.218 cells/mm^3 | 1.6838 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.318 cells/mm^3 | 1.7272 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.115 cells/mm^3 | 1.7354 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.461 cells/mm^3 | 1.4512 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.803 cells/mm^3 | 1.8525 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.315 cells/mm^3 | 2.051 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 1.261 cells/mm^3 | 1.119 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.150 cells/mm^3 | 1.0429 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.113 cells/mm^3 | 1.2168 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.370 cells/mm^3 | 1.0594 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.170 cells/mm^3 | 1.1551 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.376 cells/mm^3 | 1.092 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.281 cells/mm^3 | 4.7206 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 1.107 cells/mm^3 | 1.2924 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.222 cells/mm^3 | 1.2163 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.189 cells/mm^3 | 1.3377 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.553 cells/mm^3 | 1.3754 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.032 cells/mm^3 | 1.317 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.195 cells/mm^3 | 1.3334 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.786 cells/mm^3 | 1.3454 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 1.406 cells/mm^3 | 1.2437 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.128 cells/mm^3 | 1.2649 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.141 cells/mm^3 | 1.4642 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.412 cells/mm^3 | 1.3656 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.136 cells/mm^3 | 1.3059 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.266 cells/mm^3 | 1.4005 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.325 cells/mm^3 | 1.7918 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 1.376 cells/mm^3 | 1.8963 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.180 cells/mm^3 | 2.0821 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.269 cells/mm^3 | 1.984 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.795 cells/mm^3 | 2.2486 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.416 cells/mm^3 | 2.3613 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.284 cells/mm^3 | 2.4433 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 1.836 cells/mm^3 | 2.7709 (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
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Dimethyl Fumarate (BG00012) | 99.33 cells/mm^3 | 2.106 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.34 cells/mm^3 | 2.497 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.44 cells/mm^3 | 2.203 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.17 cells/mm^3 | 2.534 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.19 cells/mm^3 | 2.549 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.43 cells/mm^3 | 11.406 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.14 cells/mm^3 | 7.751 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 99.90 cells/mm^3 | 0.312 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.05 cells/mm^3 | 0.319 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.07 cells/mm^3 | 0.327 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.06 cells/mm^3 | 0.321 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.02 cells/mm^3 | 0.633 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.29 cells/mm^3 | 9.76 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.53 cells/mm^3 | 7.41 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 96.85 cells/mm^3 | 3.089 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.47 cells/mm^3 | 3.63 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.59 cells/mm^3 | 3.532 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.59 cells/mm^3 | 3.71 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.38 cells/mm^3 | 3.963 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.55 cells/mm^3 | 10.918 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -2.31 cells/mm^3 | 8.402 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 99.81 cells/mm^3 | 0.933 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.04 cells/mm^3 | 0.867 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.02 cells/mm^3 | 1.573 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.10 cells/mm^3 | 1.25 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.01 cells/mm^3 | 1.477 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.27 cells/mm^3 | 10.857 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.84 cells/mm^3 | 7.813 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 98.24 cells/mm^3 | 1.87 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.04 cells/mm^3 | 2.227 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.07 cells/mm^3 | 2.649 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.26 cells/mm^3 | 2.604 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.35 cells/mm^3 | 2.519 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.99 cells/mm^3 | 10.532 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -2.56 cells/mm^3 | 8.696 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 98.00 cells/mm^3 | 2.303 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.29 cells/mm^3 | 3.241 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.92 cells/mm^3 | 2.416 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.77 cells/mm^3 | 2.539 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.40 cells/mm^3 | 3.046 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.36 cells/mm^3 | 7.843 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.52 cells/mm^3 | 7.711 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 97.80 cells/mm^3 | 5.352 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.83 cells/mm^3 | 6.672 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 1.23 cells/mm^3 | 5.675 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.55 cells/mm^3 | 6.113 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.35 cells/mm^3 | 9.22 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -2.88 cells/mm^3 | 18.513 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.42 cells/mm^3 | 10.736 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 99.87 cells/mm^3 | 0.679 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.50 cells/mm^3 | 7.105 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.00 cells/mm^3 | 0.642 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.01 cells/mm^3 | 0.486 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.01 cells/mm^3 | 0.663 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.07 cells/mm^3 | 0.744 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.04 cells/mm^3 | 0.964 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 91.23 cells/mm^3 | 4.427 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.45 cells/mm^3 | 6.909 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.11 cells/mm^3 | 2.055 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.06 cells/mm^3 | 1.93 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.12 cells/mm^3 | 2.209 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.32 cells/mm^3 | 4.256 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.02 cells/mm^3 | 2.935 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 86.79 cells/mm^3 | 5.369 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.23 cells/mm^3 | 8.274 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.38 cells/mm^3 | 5.6 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.85 cells/mm^3 | 5.9 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.07 cells/mm^3 | 6.051 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.46 cells/mm^3 | 8.264 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.25 cells/mm^3 | 6.561 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 99.77 cells/mm^3 | 0.771 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.42 cells/mm^3 | 7.185 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.12 cells/mm^3 | 0.874 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.03 cells/mm^3 | 1.252 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.00 cells/mm^3 | 1.162 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.06 cells/mm^3 | 1.532 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.23 cells/mm^3 | 1.53 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 91.29 cells/mm^3 | 4.715 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.31 cells/mm^3 | 7.26 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.03 cells/mm^3 | 5.899 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.44 cells/mm^3 | 2.989 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.01 cells/mm^3 | 3.237 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.75 cells/mm^3 | 5.045 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -1.10 cells/mm^3 | 5.739 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 88.77 cells/mm^3 | 8.126 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.82 cells/mm^3 | 10.895 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.96 cells/mm^3 | 10.161 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.82 cells/mm^3 | 10.35 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.98 cells/mm^3 | 9.793 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 3.87 cells/mm^3 | 9.683 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.69 cells/mm^3 | 10.594 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 5.61 cells/mm^3 | 7.277 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 4.43 cells/mm^3 | 9.345 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 1.17 cells/mm^3 | 4.892 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.27 cells/mm^3 | 4.137 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.67 cells/mm^3 | 10.365 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | -0.29 cells/mm^3 | 12.678 (Standard Deviation) | 218 |
| Dimethyl Fumarate (BG00012) | 0.92 cells/mm^3 | 10.291 (Standard Deviation) | 218 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Dimethyl Fumarate (BG00012) | 218 | 26 (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 responseChange 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 responseChange 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 responseChange 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 responseChange 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 responseChange 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 responseThe 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
Results
Real-World Safety and Effectiveness of Dimethyl Fumarate in Patients with MS: Results from the ESTEEM Phase 4 and PROCLAIM Phase 3 Studies with a Focus on Older Patients.Adv Ther · 2025
Results
Dimethyl fumarate treatment shifts the immune environment toward an anti-inflammatory cell profile while maintaining protective humoral immunity.Mult Scler · 2021
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History
Started
Aug 2015
Main results due
Apr 2017
Finished
Apr 2018
Results posted
Jun 2019