Table 1.
Baseline demographics and disease characteristics and stratification criteria (all-randomized populationa)
| Variable b |
CT-P13 s.c.
(n = 167) |
CT-P13 i.v.
(n = 176) |
|---|---|---|
| Age, years | 50.9 (12.17) | 51.9 (12.42) |
| Sex, n (%) | ||
| Female | 130 (77.8) | 139 (79.0) |
| Race, n (%) | ||
| Asian/Oriental | 1 (0.6) | 2 (1.1) |
| White/Caucasian | 145 (86.8) | 151 (85.8) |
| Other | 21 (12.6) | 23 (13.1) |
| Screening height, cm | 164.73 (9.20) | 164.33 (9.31) |
| Screening weight, kg | 73.01 (15.13) | 72.75 (14.40) |
| Screening BMI, kg/m2 | 26.79 (4.42) | 26.82 (4.13) |
| Time since RA diagnosis, years | 6.82 (7.15) | 6.41 (6.39) |
| DAS28-CRPc | 6.01 (0.75) | 5.86 (0.81) |
| DAS28-ESRc | 6.70 (0.79) | 6.56 (0.78) |
| Tender joint count (DAS28 assessment)c | 16.1 (5.33) | 14.8 (5.55) |
| Swollen joint count (DAS28 assessment)c | 12.4 (4.42) | 11.0 (4.32) |
| HAQ estimate of physical abilityc | 1.58 (0.53) | 1.58 (0.60) |
| CDAIc | 42.53 (10.09) | 39.59 (10.08) |
| SDAIc | 44.36 (10.65) | 41.86 (11.12) |
| Patient’s assessment of pain (VAS)c | 69.09 (17.43) | 68.57 (17.85) |
| Patient’s global assessment of disease activity (VAS)c | 70.36 (15.80) | 69.16 (17.40) |
| Physician’s global assessment of disease activity (VAS)c | 70.22 (13.95) | 68.80 (15.26) |
| ESR, mm/hc | 41.8 (19.26) | 44.5 (23.61) |
| CRP, mg/dlc | 1.84 (2.39) | 2.24 (3.53) |
| MTX dose at first administration (mg/week)d | 17.01 (3.99) | 17.40 (3.98) |
| MTX dose at first administration of maintenance phase (mg/week)d | 16.98 (3.98) | 17.40 (3.98) |
| Stratification factors | ||
| Weight (W6), n (%) | ||
| >100 kg | 7 (4.2) | 10 (5.7) |
| ≤100 kg | 160 (95.8) | 166 (94.3) |
| Serum CRP (W2), n (%) | ||
| >0.6 mg/dl | 34 (20.4) | 47 (26.7) |
| ≤0.6 mg/dl | 133 (79.6) | 129 (73.3) |
a
Analysed according to randomized treatment at W6. bExcept where indicated otherwise, values are mean (s.d.). cEfficacy population; CT-P13 s.c. (n = 165) and CT-P13 i.v. (n = 174). dSafety population; CT-P13 s.c. (n = 168), CT-P13 i.v. (n = 175).
CDAI, Clinical Disease Activity Index; DAS28, disease activity score in 28 joints; SDAI, Simplified Disease Activity Index; VAS, visual analogue scale; W, week.