Table 1.
Demographics and baseline characteristics of randomized population (N = 755)*
IE | IT | SE | ST | |
---|---|---|---|---|
N, % of total in treatment arm | 244 (32.3) | 132 (17.5) | 255 (33.8) | 124 (16.4) |
Age, years | 50.7±13.4 | 48.8±12.7 | 48.6±13.0 | 49.3±12.0 |
Female | 181 (74.2) | 101 (76.5) | 176 (69.0) | 87 (70.2) |
Race: Caucasian | 188 (77.1) | 107 (81.1) | 200 (78.4) | 106 (85.5) |
African American | 31 (12.7) | 11 (8.3) | 29 (11.4) | 14 (11.3) |
Ethnicity: Hispanic/Latino | 26 (10.7) | 17 (12.9) | 32 (12.6) | 10 (8.1) |
Body Mass Index | 29.3±7.0 | 30.0±8.2 | 30.0±6.7 | 29.2±7.3 |
Disease duration (months) | 3.5±6.4 | 4.1±7.2 | 2.9±5.6 | 4.5±7.6 |
RF + | 216 (88.5) | 121 (91.7) | 232 (91.0) | 108 (87.1) |
RF− and CCP+ | 8 (3.3) | 4(3.0) | 9 (3.5) | 4(3.2) |
CCP−/not tested with 2 erosions | 20 (8.2) | 7(5.3) | 14 (5.5) | 12 (9.7) |
Prior DMARD use | 68 (27.9) | 30 (22.7) | 58 (22.8) | 22 (17.7) |
Etanercept use** | 0 | 0 | 1 (0.4) | 0 |
Infliximab use** | 1 (0.4) | 0 | 0 | 0 |
Anakinra use** | 1 (0.4) | 0 | 1 (0.4) | 0 |
HCQ use | 5 (2.1) | 3 (2.3) | 4(1.6) | 3 (2.4) |
SSZ use | 1(0.4) | 0 | 0 | 1 (0.8) |
MTX use | 60 (24.6) | 27 (20.5) | 52 (20.4) | 18 (14.5) |
MTX use > 40 mg total** | 3 (1.2) | 1 (0.8) | 3(1.2) | 3(2.4) |
Taking low-dose corticosteroids at screening: | 105 (43.0) | 58 (43.9) | 111 (43.5) | 41 (33.1) |
Mean dose, if corticosteroid use at screening (mg prednisone/day) |
3.4±4.3 | 3.4±4.2 | 3.4±4.3 | 2.6±4.1 |
Mean±SD or number of participants (%), no differences across treatment arms, all p>0.05
Protocol Exception/Violation