Table 1. Subject baseline characteristics.
| Characteristic | Placebo (n = 14) | CDP323 100 mg bid (n = 14) | CDP323 500 mg bid (n = 15) | CDP323 1000 mg qd (n = 14) | CDP323 1000 mg bid (n = 14) | Overall (N = 71) |
| Age, mean, y (range) | 45.5 (25.5–60.1) | 46.4 (36.3–62.3) | 46.0 (27.4–59.0) | 45.4 (24.8–59.7) | 47.2 (41.3–53.9) | 46.1 (24.8–62.3) |
| Female, n (%) | 6 (42.9) | 7 (50.0) | 12 (80.0) | 8 (57.1) | 11 (78.6) | 44 (62.0) |
| Caucasian, n (%) | 13 (92.9) | 14 (100) | 13 (86.7) | 12 (85.7) | 14 (100) | 66 (93.0) |
| BMI, mean (range) | 27.7 (18.1–38.0) | 28.4 (21.2–43.3) | 28.1 (21.6–39.9) | 27.9 (20.4–45.2) | 28.5 (18.3–45.0) | 28.1 (18.1–45.2) |
| Creatinine clearance, mean,mL/min (range)a | 134.1 (79–212) | 114.5 (79–227) | 113.9 (86–192) | 126.6 (78–222) | 121.9 (75–231) | 122.2 (75–231) |
| Type of MS, n (%) | ||||||
| Relapsing remitting | 11 (78.6) | 10 (71.4) | 11 (73.3) | 8 (57.1) | 10 (71.4) | 50 (70.4) |
| Secondary progressive | 3 (21.4) | 4 (28.6) | 4 (26.7) | 6 (42.9) | 4 (28.6) | 21 (29.6) |
| EDSS | ||||||
| Mean (SD) | 5.5 (1.5) | 4.3 (1.7) | 4.9 (1.6) | 4.8 (1.8) | 5.2 (1.7) | 4.9 (1.7) |
| Median (range) | 6.0 (1.5–6.5) | 4.8 (2.0–6.5) | 6.0 (2.0–6.5) | 5.8 (2.0–6.5) | 6.0 (1.0–6.5) | 6.0 (1.0–6.5) |
| Relapses in last 12 months | ||||||
| Mean (SD) | 1.6 (1.9) | 1.1 (0.9) | 1.1 (0.8) | 1.6 (1.0) | 1.1 (0.9) | 1.3 (1.2) |
| Median (range)b | 1.0 (0–8) | 1.0 (0–3) | 1.0 (0–3) | 1.0 (0–3) | 1.0 (0–3) | 1.0 (0–8) |
a
Determined by Cockroft formula: males = [(140 − age)×body weight]/[72×serum creatinine (mg/dL)]; females = [(140 − age)×body weight]/[72×serum creatinine (mg/dL)]×0.85.
b
Although 12 subjects had not experienced a relapse in the previous 12 months (4 in the 1000-mg bid group, 3 in each of the 100-mg bid and 500-mg bid groups, and 1 in each of the 1000-mg qd and placebo groups), they all fulfilled the inclusion criteria of having had at least one relapse in the previous 24 months.
bid = twice daily; BMI = body mass index; EDSS = Expanded Disability Status Scale; qd = once daily; SD = standard deviation.