Table 1 Demographic details of the patients
| Â | Part A | Part B | Part C | Pooled | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Â | 0.03 mg/kg | 0.06 mg/kg | 0.3 mg/kg | 3 mg/kg | 10 mg/kg | 20 mg/kg | 30 mg/kg | 6 mg/kg | 500 mg | Placebo |
Number of patients randomized | 3 | 1 | 8 | 12 | 12 | 6 | 6 | 37 | 12 | 38a |
Age in Years, Mean (SD) | 45.7 (9.3) | 46.0 | 50.3 (3.3) | 51.1 (8.0) | 52.8 (13.4) | 58.8 (8.3) | 53.2 (5.0) | 53.7 (10.1) | 55.6 (13.2) | 56.2 (11.4) |
Gender, n (%) | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Female: (%) | 3 (100) | 1 (100) | 5 (63) | 9 (75) | 5 (42) | 4 (67) | 4 (7) | 23 (62) | 10 (83) | 35 (92) |
Male: (%) | Â | Â | 3 (37) | 3 (25) | 7 (58) | 2 (33) | 2 (33) | 14 (38) | 2 (17) | 3 (8) |
BMI in kg/mb, Mean (SD) | 28.0 (3.6) | 25.7 | 27.1 (3.9) | 24.8(3.1) | 25.2(2.8) | 28.3 (3.9) | 25.3 (5.8) | 26.4 (3.5) | 27.9(5.1) | 27.5 (4.4) |
Disease Duration in years, Mean (SD) | 8.4 (10.2) | 2.5 | 6.7 (7.0) | 6.0 (6.6) | 3.92 (3.4) | 14.7 (10.4) | 13.4 (13.3) | 8.0 (6.9) | 8.92 (7.8) | 8.0 (7.7) |
Number of Prior DMARDs, Mean (SD) | 3 (0) | 2 | 2.4 (0.5) | 2.7 (0.8) | 2.5 (0.7) | 3.3 (1.5) | 2.7 (1.2) | 2.4 (0.7) | 2.2 (0.6) | 2.4 (0.7) |
Rheumatoid Factor Positive N (%) | 2 (66) | 1 (100) | 8 (100) | 10 (83) | 7 (58) | 6 (100) | 6 (100) | 31 (84) | 12 (100) | 31 (82) |
Anti-CCP antibodies positive N (%) | 22(67) | 1 (100) | 8 (100) | 9 (75) | 10 (83) | 6 (100) | 6 (100) | NA | NA | 12 (75) |
Baseline DAS28ESR, Median | 5.87 | 6.77 | 6.47 | 6.66 | 6.15 | 6.91 | 6.59 | 6.43 | 6.40 | 6.19 |