Baseline patient and disease characteristics. Baseline measurements were defined as those closest to the measurement taken before the first intravenous infusion of study agent in the main study. Values are mean (median) or n (%) unless otherwise noted.
| Characteristics | Placebo Plus MTX | Golimumab Only | Golimumab Plus MTX | ||||||
|---|---|---|---|---|---|---|---|---|---|
| 2 mg/kg | 4 mg/kg | Combined | 2 mg/kg | 4 mg/kg | EE/DRA to 2 mg/kg | EE/DRA to 4 mg/kg | Combined | ||
| Pts randomized in main study | 129 | 128 | 129 | 257 | 129 | 128 | — | — | 257 |
| Pts randomized and still participating at LTE-0 | 3 | 59 | 63 | 122 | 82 | 104 | 24 | 173 | 383 |
| Women, n (%) | 2 (66.7) | 54 (91.5) | 52 (82.5) | 106 (86.9) | 61 (74.4) | 86 (82.7) | 18 (75.0) | 138 (79.8) | 303 (79.1) |
| Race, n (%) | |||||||||
| White | 0 (0.0) | 39 (66.1) | 41 (65.1) | 80 (65.6) | 54 (65.9) | 71 (68.3) | 16 (66.7) | 130 (75.1) | 271 (70.8) |
| Black | 0 (0.0) | 0 (0.0) | 1 (1.6) | 1 (0.8) | 0 (0.0) | 2 (1.9) | 0 (0.0) | 4 (2.3) | 6 (1.6) |
| Asian | 2 (66.7) | 7 (11.9) | 9 (14.3) | 16 (13.1) | 7 (8.5) | 8 (7.7) | 1 (4.2) | 11 (6.4) | 27 (7.0) |
| Other | 1 (33.3) | 13 (22.0) | 12 (19.0) | 25 (20.5) | 21 (25.6) | 23 (22.1) | 7 (29.2) | 28 (16.2) | 79 (20.6) |
| Age, yrs | 49.3 (51.0) | 50.7 (51.0) | 45.3 (45.0) | 47.9 (48.0) | 48.9 (50.5) | 49.1 (51.0) | 50.5 (52.5) | 50.3 (51.0) | 49.7 (51.0) |
| RA duration, yrs | 8.4 (5.4) | 7.0 (3.9) | 8.0 (7.1) | 7.5 (6.1) | 7.9 (4.5) | 9.2 (7.2) | 7.2 (6.1) | 7.6 (5.6) | 8.1 (5.8) |
| No. swollen joints (0–66) | 12.7 (13.0) | 15.7 (14.0) | 15.2 (14.0) | 15.4 (14.0) | 15.8 (13.0) | 14.8 (13.0) | 12.5 (13.0) | 15.0 (13.0) | 14.9 (13.0) |
| No. tender joints (0–68) | 42.7 (48.0) | 27.9 (23.0) | 26.5 (23.0) | 27.2 (23.0) | 28.4 (23.5) | 26.8 (23.0) | 24.0 (22.0) | 27.1 (24.0) | 27.1 (23.0) |
| CRP, mg/dl | 3.0 (1.9) | 2.3 (1.4) | 1.5 (0.8) | 1.9 (1.0) | 1.8 (1.1) | 2.0 (1.2) | 1.2 (0.7) | 1.5 (0.8) | 1.7 (0.9) |
| HAQ (0–3) | 2.1 (2.3) | 1.6 (1.6) | 1.5 (1.5) | 1.5 (1.6) | 1.6 (1.8) | 1.5 (1.6) | 1.4 (1.3) | 1.4 (1.5) | 1.5 (1.5) |
CRP: C-reactive protein; DRA: dosage regimen adjustment at Week 24; EE: early escape at Week 16; HAQ: Health Assessment Questionnaire-Disability Index; LTE: longterm extension; MTX: methotrexate; RA: rheumatoid arthritis.