Baseline demographics and disease characteristics*
| CT-P13 3 mg/kg (N=302) | INX 3 mg/kg (N=304) | Total (N=606) | |
|---|---|---|---|
| Age (years) | |||
| Median (range) | 50 (18–75) | 50 (21–74) | 50 (18–75) |
| Gender, no (%) | |||
| Female | 245 (81.1) | 256 (84.2) | 501 (82.7) |
| Male | 57 (18.9) | 48 (15.8) | 105 (17.3) |
| Ethnicity, no (%) | |||
| Asian | 34 (11.3) | 37 (12.2) | 71 (11.7) |
| Black | 2 (0.7) | 1 (0.3) | 3 (0.5) |
| White | 220 (72.8) | 222 (73.0) | 442 (72.9) |
| Other | 46 (15.2) | 44 (14.5) | 90 (14.9) |
| Height (cm), median (range) | 162.3 (144.0–186.0) | 162.0 (124.0–190.0) | 162.0 (124.0–190.0) |
| Weight (kg), median (range) | 69.0 (36.5–134.0) | 68.0 (36.0–136.0) | 68.6 (36.0–136.0) |
| BMI (kg/m2), median (range) | 26.3 (13.9–49.8) | 25.4 (15.0–53.1) | 25.9 (13.9–53.1) |
| Anti-CCP antibody-positive, no (%) | 205 (67.9) | 213 (70.1) | 418 (69.0) |
| Joint count | |||
| TJC (68 joints) | 25.6 (13.9) | 24.0 (12.9) | 24.8 (13.4) |
| SJC (66 joints) | 16.2 (8.7) | 15.2 (8.3) | 15.7 (8.5) |
| TJC (28 joints) | 15.9 (6.4) | 15.1 (6.1) | 15.5 (6.2) |
| SJC (28 joints) | 12.0 (4.9) | 11.2 (4.7) | 11.6 (4.8) |
| Duration of prior MTX therapy (weeks) | 97.7 (141.2) | 89.4 (96.5) | 93.6 (120.8) |
| MTX dose (mg) | 15.6 (3.1) | 15.6 (3. 2) | 15.6 (3.1) |
| CDAI | 40.9 (11.5) | 39.3 (11.1) | 40.1 (11.3) |
| SDAI | 42.8 (11.9) | 41.2 (11.7) | 42.0 (11.8) |
| CRP (mg/dl) | 1.9 (2.5) | 1.9 (2.2) | 1.9 (2.4) |
| ESR (mm/h) | 46.6 (22.4) | 48.5 (22.6) | 47.5 (22.5) |
| Anti-CCP (IU/ml) | 190.4 (124.1) | 197.9 (122.7) | 194.1 (123.3) |
| IgA RF (IU/ml) | 54.9 (88.9) | 65.8 (99.3) | 60.3 (94.3) |
| IgM RF (IU/ml) | 123.3 (114.6) | 129.5 (113.8) | 126.4 (114.1) |
| IgG RF (IU/ml) | 68.4 (89.4) | 66.2 (85.4) | 67.3 (87.3) |
| DAS28–CRP | 5.9 (0.8) | 5.8 (0.9) | 5.8 (0.9) |
| HAQ | 1.6 (0.6) | 1.6 (0.6) | 1.6 (0.6) |
| Patient's assessment of pain | 65.9 (17.4) | 65.5 (17.2) | 65.7 (17.3) |
| Patient global assessment of disease activity | 65.7 (17.2) | 65.4 (17.0) | 65.5 (17.1) |
| Physician global assessment of disease activity | 64.7 (14.3) | 65.0 (13.5) | 64.8 (13.9) |
*Except where indicated otherwise, values are the mean (SD).
BMI, body mass index; CCP, cyclic citrullinated peptide; CDAI, Clinical Disease Activity Index; CRP, C reactive protein; DAS28, Disease Activity Score in 28 joints; ESR, erythrocyte sedimentation rate; HAQ, health assessment questionnaire; Ig, immunoglobulin; INX, innovator infliximab; MTX, methotrexate; RF, rheumatoid factor; SDAI, Simplified Disease Activity Index; SJC, swollen joint count; TJC, tender joint count.