Baseline demographics and clinical characteristics (full analysis set)
| Variable | ABP 501 (n=264) | Adalimumab (n=262) |
| Age, mean (SD), years | 55.4 (11.9) | 56.3 (11.5) |
| Women, n (%) | 214 (81.1) | 212 (80.9) |
| Race, n (%) | ||
| White | 251 (95.1) | 249 (95.0) |
| Black or African American | 9 (3.4) | 12 (4.6) |
| Asian | 3 (1.1) | 0 (0.0) |
| Other | 1 (0.4) | 1 (0.4) |
| Region, n (%) | ||
| Eastern Europe | 169 (64.0) | 168 (64.1) |
| Western Europe | 22 (8.3) | 20 (7.6) |
| North America | 72 (27.3) | 72 (27.5) |
| Latin America | 1 (0.4) | 2 (0.8) |
| Duration of RA, mean (SD), years | 9.41 (8.08) | 9.37 (8.05) |
| Duration of RA category, n (%) | ||
| <5 years | 101 (38.3) | 90 (34.4) |
| ≥5 years | 163 (61.7) | 172 (65.6) |
| Swollen joint count, mean (SD) | 14.7 (9.1) | 14.1 (8.0) |
| Tender joint count, mean (SD) | 24.3 (14.4) | 23.9 (13.5) |
| Subject Global Health Assessment, mean (SD) | 6.5 (1.9) | 6.6 (1.9) |
| Investigator Global Health Assessment, mean (SD) | 6.8 (1.3) | 6.7 (1.6) |
| HAQ-DI, mean (SD)* | 1.482 (0.617) | 1.498 (0.647) |
| Serum CRP, mean (SD), mg/L | 13.881 (20.687) | 14.678 (19.385) |
| Serum CRP, median, mg/L | 6.140 | 7.630 |
| DAS28-CRP, mean (SD)† | 5.66 (0.92) | 5.68 (0.91) |
| RF status, n (%)‡‡ | ||
| Positive | 243 (92.0) | 240 (91.6) |
| Anti-CCP status, n (%)‡ | ||
| Positive | 212 (80.3) | 230 (87.8) |
| Prior biologic use for RA, n (%) | ||
| Yes | 71 (26.9) | 74 (28.2) |
| MTX dose, mean (SD), mg/week | 16.89 (4.81) | 16.56 (4.93) |
*ABP 501, n=263; adalimumab, n=261; total, n=524.
†ABP 501, n=264; adalimumab, n=261; total, n=525.
‡At screening.
CCP, cyclic citrullinated peptide; CRP, C reactive protein; DAS28, Disease Activity Score 28-joint count; HAQ-DI, Health Assessment Questionnaire-Disability Index; MTX, methotrexate; RA, rheumatoid arthritis; RF, rheumatoid factor.