Summary of baseline demographic and disease characteristics. Values are mean ± SD or n (%) unless otherwise specified.
| Characteristics | Placebo | JNJ-40346527 100 mg Twice Daily | All Patients |
|---|---|---|---|
| Patients randomized, n | 33 | 63 | 96 |
| Age, yrs | 54.7 ± 10.6 | 54.2 ± 11.1 | 54.3 ± 10.8 |
| Female | 29 (87.9) | 55 (87.3) | 84 (87.5) |
| Race | |||
| White | 30 (90.9) | 56 (88.9) | 86 (89.6) |
| Asian | 3 (9.1) | 7 (11.1) | 10 (10.4) |
| Disease duration, yrs | 6.6 ± 4.1 | 7.7 ± 5.5 | 7.3 ± 5.0 |
| TJC, 0–68 | 22.9 ± 21.0 | 24.6 ± 22.0 | 24.0 ± 21.5 |
| SJC, 0–66 | 14.7 ± 12.0 | 14.8 ± 14.0 | 14.8 ± 13.0 |
| DAS28-CRP | 5.9 ± 0.9 | 6.0 ± 0.8 | 5.9 ± 0.8 |
| HAQ-DI, 0–3 | 1.7 ± 1.8 | 1.7 ± 1.8 | 1.7 ± 1.8 |
| CRP, mg/dl | 2.3 ± 1.3 | 2.2 ± 1.6 | 2.2 ± 1.5 |
| Use at baseline | |||
| Methotrexate | 29 (87.9) | 59 (93.7) | 88 (91.7) |
| Dose, mg/wk | 14.5 ± 5.3 | 16.1 ± 4.9 | 15.6 ± 5.1 |
| Hydroxychloroquine | 2 (6.0) | 9 (13.8) | 11 (11.5) |
| Dose, mg/day | 350.0 ± 70.7 | 283.3 ± 93.5 | 295.5 ± 90.7 |
| Sulfasalazine | 6 (18.2) | 9 (13.8) | 15 (15.6) |
| Dose, mg/day | 1916.7 ± 664.6 | 1500.0 ± 559.0 | 1666.7 ± 617.2 |
| Combination DMARD use* | 1 (3.0) | 2 (3.2) | 3 (3.1) |
| Prednisone | 17 (51.5) | 39 (61.9) | 56 (58.3) |
| Dose, mg/day | 6.5 ± 2.6 | 6.2 ± 2.6 | 6.3 ± 2.6 |
↵* Patients received hydroxychloroquine (200–400 mg/day) plus sulfasalazine (1000–1500 mg/day). TJC: tender joint count; SJC: swollen joint count; DAS28: 28-joint Disease Activity Score; CRP: C-reactive protein; HAQ-DI: Health Assessment Questionnaire–Disability Index; DMARD: disease-modifying antirheumatic drug.