Table 1 Baseline demographics and Disease characteristics (all enrolled patients)
Characteristic | DRL_RI (N = 70) | RP/RMP (N = 70) | Total (N = 140) |
|---|---|---|---|
Age, years | |||
Mean (SD) | 59.5 (11.7) | 60.1 (11.8) | 59.8 (11.7) |
Min, Max | 34, 85 | 24, 86 | 24, 86 |
Gender, n (%) | |||
Male | 16 (22.9) | 9 (12.9) | 25 (17.9) |
Female | 54 (77.1) | 61 (87.1) | 115 (82.1) |
Race, n (%) | |||
White | 69 (98.6) | 70 (100) | 139 (99.3) |
Black or African American | 1 (1.4) | 0 | 1 (0.7) |
Ethnicity, n (%) | |||
Hispanic or Latino | 7 (10.0) | 5 (7.1) | 12 (8.6) |
Not Hispanic or Latino | 60 (85.7) | 64 (91.4) | 124 (88.6) |
Unknown | 3 (4.3) | 1 (1.4) | 4 (2.9) |
Baseline BMI, kg/m2 | |||
Mean (SD) | 28.3 (5.5) | 27.2 (6.8) | 27.8 (6.2) |
Min, Max | 19.1, 45.7 | 17.5, 52.0 | 17.5, 52.0 |
Source of rituximab drug in prior exposure | |||
RP: Reference Product [US-rituximab] | 23 (32.9) | 22 (31.4) | 45 (32.1) |
RMP: Reference Medicinal Product [EU-rituximab] | 47 (67.1) | 48 (68.6) | 95 (67.9) |
Duration of RA at randomization, Months Mean (SD) | 134.6 (69.5) | 104.4 (52.7) | 120.6 (63.1) |
Time from prior rituximab treatment, Months Mean (SD) | 7.5 (2.7) | 7.6 (2.9) | 7.6 (2.8) |
Patients with prior treatment course(s) with rituximab, n (%) | |||
1 | 21 (30.0) | 26 (37.1) | 47 (33.6) |
> 1 | 49 (70.0) | 44 (62.9) | 93 (66.4) |