Baseline demographics and disease characteristics
| Characteristics | BMS945429 80 mg +MTX (n=32) | BMS945429 160 mg +MTX (n=33) | BMS945429 320 mg +MTX (n=29) | Placebo+MTX (n=33) |
|---|---|---|---|---|
| Age, years | 53 (10) | 55 (11) | 50 (12) | 52 (12) |
| Body weight, kg | 74 (17) | 77 (14) | 71 (15) | 74 (19) |
| Time since RA diagnosis, years | 7 (6) | 7 (7) | 6 (5) | 8 (6) |
| Weekly MTX dose, mg | 13 (4) | 13 (3) | 13 (3) | 13 (3) |
| Oral steroid usage, n (%) | 22 (69) | 20 (61) | 16 (55) | 23 (70) |
| Folic acid usage, n (%) | 27 (84) | 26 (79) | 23 (79) | 28 (85) |
| NSAID usage, n (%) | 25 (78) | 27 (82) | 22 (76) | 27 (82) |
| RF status positive, n (%) | 25 (78) | 32 (97) | 26 (90) | 27 (82) |
| RF, IU/ml | 150 (252) | 141 (152) | 123 (104) | 145 (48) |
| CCP status positive, n (%) | 19 (59) | 32 (97) | 25 (86) | 26 (79) |
| Swollen joint count | 20 (9) | 17 (7) | 16 (6) | 15 (7) |
| Tender joint count | 27 (12) | 27 (14) | 29 (13) | 23 (12) |
| HAQ-DI | 1.7 (0.7) | 1.7 (0.5) | 1.7 (0.6) | 1.6 (0.6) |
| Pain (VAS), mm | 70.2 (21.7) | 65.8 (21.0) | 66.2 (20.2) | 63.0 (20.1) |
| Patient global assessment (VAS), mm | 70.2 (19.3) | 66.2 (20.9) | 68.7 (18.4) | 62.2 (20.2) |
| Physician global assessment (VAS), mm | 72.5 (13.8) | 65.9 (12.0) | 67.4 (14.9) | 65.5 (15.2) |
| SF-36 Physical Component Scale score | 30.48 (6.68) | 30.33 (6.30) | 32.02 (6.06) | 31.40 (6.96) |
| SF-36 Mental Component Scale score | 33.27 (12.42) | 36.09 (12.30) | 33.80 (11.00) | 36.74 (12.58) |
| CRP, mg/dl | 3.0 (3.0) | 2.6 (2.3) | 2.9 (2.5) | 3.5 (3.2) |
| DAS28 | 6.3 (0.9) | 6.2 (0.8) | 6.2 (1.0) | 6.1 (0.8) |
Data represent means ±SD unless otherwise indicated.
CCP, cyclic citrullinated peptide; CRP, C-reactive protein; DAS28, Disease Activity Score (28-joint count); HAQ-DI, Health Assessment Questionnaire Disability Index; MTX, methotrexate; NSAID, non-steroidal anti-inflammatory drug; RA, rheumatoid arthritis; RF, rheumatoid factor; VAS, visual analogue scale.