| Single dose phase | Multi dose phase | ||
---|---|---|---|---|
Characteristics | Placebo | MTRX1011A | Placebo | MTRX1011A |
Gender (Female:Male) | 4:2 | 15:9 | 6:1 | 24:5 |
Age, years Mean (range) | 51 (41 to 64) | 56 (27 to 77) | 57 (43 to 57) | 53 (25 to 76) |
Race (White:Black) | 5:1 | 23:1 | 7:0 | 24:5 |
Disease Duration (median years) | 3.8 | 5.7 | 5.0 | 8.1 |
RF positive, % | 66.7 | 58.3 | 42.9 | 34.5 |
CCP positive, % | 100 | 100 | 100 | 100 |
RF and anti-CCP positive, % | 66.7 | 58.3 | 42.9 | 34.5 |
Concomitant | Â | Â | Â | Â |
Meds: | Â | Â | Â | Â |
   % on MTX | 67 | 75 | 57 | 66 |
   % on | 0 | 4 | 14 | 0 |
leflunomide % on steroids | 33 | 50 | 43 | 48 |
CRP, mg/dL Mean (range) | 0.53 (0.50 to 0.93) | 0.65 (0.04 to 2.89) | 1.68 (003 to 3.99) | 1.11 (0.02 to 8.21) |
ESR, mm/hour Mean (range) | 26 (0 to 42) | 25 (4 to 49) | 47 (15 to 120) | 40 (0 to 110) |
SJC Mean (range) | 17 (10 to 33) | 17 (0 to 63) | 7 (0 to 16) | 18 (2 to 59) |
TJC Mean (range) | 25 (6 to 44) | 31 (1 to 68) | 36 (10 to 53) | 43 (58 to 68) |
Baseline DAS-CRP | 4.8 (3.85 to 5.68) | 5.15 (2.66 to 7.17) | 5.43 (4.28 to 6.62) | 5.93 (3.74 to 8) |