Baseline population characteristics | RCT | RCT+OLE CZP (n=4049) | |
---|---|---|---|
Placebo (n=1137) | CZP (n=2965) | ||
Mean age, years (SD) | 53.1 (11.84) | 53.3 (11.96) | 53.2 (11.96) |
Female, n (%) | 905 (79.6%) | 2372 (80.0%) | 3224 (79.6%) |
Mean disease duration (SD) | 7.95 (7.40) | 7.57 (6.83) | 7.68 (6.94) |
Duration of RA in years, n (%) | |||
≤2 years | 236 (20.8%) | 629 (21.2%) | 848 (20.9%) |
Rheumatoid factor at baseline, n (%) | |||
Negative | 168 (14.8%) | 573 (19.3%) | 707 (17.5%) |
Positive | 798 (70.2%) | 2130 (71.8%) | 2912 (71.9%) |
Unknown | 171 (15.0%) | 262 (8.8%) | 430 (10.6%) |
Geographical region, n (%) | |||
Western Europe | 278 (24.5%) | 595 (20.1%) | 800 (19.8%) |
Central Europe | 231 (20.3%) | 636 (21.5%) | 810 (20.0%) |
Eastern Europe | 102 (9.0%) | 408 (13.8%) | 503 (12.4%) |
North America | 468 (41.2%) | 1115 (37.6%) | 1673 (41.3%) |
Rest of the world | 58 (5.1%) | 211 (7.1%) | 263 (6.5%) |
Baseline steroid use, n (%) | |||
Yes | 629 (55.3%) | 1657 (55.9%) | 2229 (55.1%) |
Baseline methotrexate use, n (%) | |||
Yes | 804 (70.7%) | 2272 (76.6%) | 3082 (76.1%) |
Previous TNF inhibitor/other biological agents, n (%) | 189 (16.6%) | 518 (17.5%) | 744 (18.4%) |
CZP, certolizumab pegol; OLE, open-label extension; RA, rheumatoid arthritis; RCT, randomised controlled trial.