Table 1 Baseline demographics and disease characteristics
Demographics (Safety Population) | Placebo | ISIS-CRP Rx | ISIS-CRP Rx | ISIS-CRP Rx |
|---|---|---|---|---|
100 mg | 200 mg | 400 mg | ||
Number = 12 | Number = 12 | Number = 13 | Number = 14 | |
Race | ||||
White, number (%) | 12 (100) | 12 (100) | 13 (100) | 14 (100) |
Sex | ||||
Female, number (%) | 12 (100) | 9 (75) | 8 (61.5) | 13 (92.9) |
Age, years, mean (SD) | 64.1 (4.25) | 56.08 (13.14) | 58.69 (9.81) | 62.93 (7.97) |
Weight, kg, mean (SD) | 72.29 (13.39) | 74.05 (19.81) | 73.75 (16.43) | 72.19 (13.39) |
BMI, kg/m2, mean (SD) | 28.36 (4.97) | 27.27 (5.04) | 25.78 (4.93) | 26.84 (3.63) |
Duration of RA since 1st diagnosis, years, mean (SD) | 18.6 (15.8) | 6.3 (8.1) | 8.8 (7.8) | 18.3 (12.4) |
ACR Functional Class, number (%) | ||||
Class I | 1 (8.3) | 1 (8.3) | 0 | 1 (7.1) |
Class II | 6 (50.0) | 8 (66.7) | 7 (53.8) | 7 (50.0) |
Class III | 5 (41.7) | 3 (25.0) | 6 (46.2) | 6 (42.9) |
Morning stiffness, minutes, mean (SD) | 61.7 (29.3) | 98.3 (97.5) | 90.4 (59.0) | 106.4 (75.9) |
Disease Characteristics (Per Protocol Population) | Number = 11 | Number = 10 | Number = 8 | Number = 11 |
Westergren ESR, mm/hour, mean (SD) | 41.0 (27.7) | 47.6 (27.3) | 37.4 (14.0) | 44.5 (31.1) |
hsCRP, mg/L, mean (SD) | 22.4 (18.1) | 29.7 (29.0) | 35.2 (36.4) | 19.3 (13.6) |
Swollen joint count, mean (SD) | 12.5 (5.6) | 9.7 (6.4) | 9.8 (4.5) | 8.3 (2.2) |
Tender joint count, mean (SD) | 17.6 (8.3) | 15.9 (8.0) | 14.8 (7.5) | 14.1 (5.7) |
DAS28-ESR, mean (SD) | 6.66 (0.6) | 6.36 (1.1) | 6.27 (0.7) | 6.23 (0.9) |
HAQ, mean (SD) | 1.67 (0.6) | 1.50 (0.7) | 1.58 (0.6) | 1.73 (0.6) |
Patient’s pain assessment, mean (SD) | 66.82 (16.4) | 54.50 (16.6) | 59.75 (13.2) | 61.55 (18.4) |
Patient’s global assessment of disease activity, mean (SD) | 2.64 (0.7) | 2.30 (0.7) | 2.38 (0.5) | 2.45 (0.5) |
Physician’s global assessment of disease activity, mean (SD) | 2.18 (0.4) | 2.10 (0.7) | 2.50 (0.5) | 2.36 (0.5) |