Table 1.
Summary of MS medical history at screening (ITT population)
| Placebo (N = 66) | GSK239512 (N = 65) | Total (N = 131) | |
|---|---|---|---|
| Age (years), mean (range) | 36.2 (19–50) | 36.4 (22–49) | 36.3 (19–50) |
| Female, n (%) | 41 (62) | 42 (65) | 83 (63) |
| Weight (kg), mean (range) | 73.19 (48–128) | 70.07 (48–109) | 71.65 (48–128) |
| Body mass index (kg/m2), mean (range) | 24.92 (16.0–40.4) | 24.18 (16.9–36.7) | 24.55 (16.0–40.4) |
| Caucasian, n (%) | 66 (100) | 65 (100) | 131 (100) |
| Years since confirmation of diagnosis | 5.12 (2.971) | 4.74 (2.896) | 4.93 (2.929) |
| Years since onset of symptoms | 7.55 (3.920) | 7.73 (4.383) | 7.64 (4.141) |
| Receiving disease-modifying treatment, n (%) | |||
| Intramuscular interferon-β1a | 38 (58) | 37 (57) | 75 (57) |
| Glatiramer acetate | 28 (42) | 28 (43) | 56 (43) |
| Total number of relapses | 4.2 (2.84) | 4.2 (2.82) | 4.2 (2.82) |
| Number of relapses (last 12 months) | 1.1 (0.49) | 1.1 (0.55) | 1.1 (0.52) |
| Number of relapses (last 24 months) | 1.8 (1.04) | 1.8 (1.02) | 1.8 (1.02) |
| Days since last relapsea | |||
| Mean (SD) | 184.9 (180.77) | 232.3 (265.77) | 208.4 (227.33) |
| Median (range) | 129 (7, 1243) | 184 (7, 1597) | 160 (7, 1597) |
| Number of scans with GdE lesions in last 12 monthsb, n (%)c | n = 28 | n = 40 | n = 68 |
| 0 | 13 (46) | 22 (55) | 35 (51) |
| 1 | 14 (50) | 18 (45) | 32 (47) |
| 2 | 1 (4) | 0 | 1 (1) |
| T2 lesion MTR at screening MRI, mean (SD) | −0.036 (0.324) | −0.048 (0.385) | |
| Whole brain volume at screening MRI (cm2), mean (SD) | 1486.3 (79.78) | 1475.4 (68.87) | |
| EDSS scores at screening, median (min, max) | 2.50 (1.0–4.5) | 2.50 (1.0–4.5) | |
Data shown represent mean (SD) unless otherwise specified
EDDS Expanded Disability Status Scale, GdE Gadolinium-enhanced, ITT intent-to-treat, MRI magnetic resonance imaging, MS multiple sclerosis, MTR magnetisation transfer ratio, SD standard deviation
aDays since last relapse are calculated based on the screening visit and date of relapse
bSubset of patients that had an MRI for GdE lesions in the 12 months before study enrolment
cProportion of patients with scan data