Baseline demographic and disease characteristics (intent-to-treat population)
| Placebo + MTX (n=249) | Rituximab (2×500 mg) + MTX (n=249) | Rituximab (2×1000 mg) + MTX (n=250) | |
|---|---|---|---|
| Female | 192 (77%) | 203 (82%) | 212 (85%) |
| Age (years) | 48.1 (12.7) | 47.9 (13.4) | 47.9 (13.3) |
| Disease duration (years) | |||
| Mean (SD) | 0.91 (1.1) | 0.99 (1.1) | 0.92 (1.3) |
| Median (range) | 0.4 (0.01–8.37) | 0.5 (0.00–3.95) | 0.4 (0.01–11.88) |
| Percentage with disease duration <2 years | 86 | 80 | 83 |
| No previous DMARD therapy | 174 (70%) | 178 (72%) | 172 (69%) |
| Receiving concomitant corticosteroids | 119 (48%) | 117 (47%) | 111 (44%) |
| Receiving concomitant NSAIDs and/or COX-2 inhibitors | 173 (69%) | 179 (72%) | 191 (76%) |
| Swollen joint count (0–66 possible joints) | 20.0 (12.0) | 22.4 (12.8) | 21.6 (11.0) |
| Tender joint count (0–68 possible joints) | 32.7 (16.6) | 34.0 (15.7) | 33.2 (15.0) |
| C-reactive protein (mg/dl) | 3.2 (2.8) | 3.4 (3.1) | 3.0 (2.7) |
| Health Assessment Questionnaire (0–3 range) | 1.8 (0.6) | 1.8 (0.7) | 1.7 (0.7) |
| DAS28-ESR | 7.1 (1.0) | 7.1 (1.0) | 7.0 (1.0) |
| Rheumatoid factor positive | 217 (87%) | 216 (87%) | 213 (85%) |
| Baseline mean mTSS | 7.4 (10.9) | 7.7 (11.7) | 6.9 (10.6) |
Data are mean (SD) or number (%) unless otherwise stated.
COX-2, cyclo-oxygenase-2; DAS28, Disease Activity Score in 28 joints; DMARD, disease-modifying antirheumatic drug; ESR, erythrocyte sedimentation rate; mTSS, Genant-modified total Sharp score; MTX, methotrexate; NSAID, non-steroidal anti-inflammatory drug.