Patient demographics and characteristics (safety population) at baseline
| Placebo+MTX (n=63) | Rituximab 500 mg+MTX (n=62) | Rituximab 1000 mg+MTX (n=60) | |
|---|---|---|---|
| Female, n (%) | 48 (76.2) | 45 (72.6) | 50 (83.3) |
| Age, mean (SD), years | 50.3 (11.9) | 48.7 (11.1) | 50.7 (11.7) |
| RA duration, mean (SD), years | 4.4 (3.1) | 4.5 (2.9) | 4.9 (2.9) |
| MTX dose, mean (SD), mg/wk | 16.8 (3.3) | 15.8 (4.0) | 15.2 (3.5) |
| Concomitant CS, n (%) | 35 (55.6) | 33 (53.2) | 35 (58.3) |
| SJC, mean (SD) | 11.4 (6.1) | 12.5 (7.1) | 10.9 (5.9) |
| TJC, mean (SD) | 14.9 (6.7) | 15.2 (7.5) | 14.0 (6.9) |
| DAS28-CRP, mean (SD) | 5.6 (1.1) | 5.6 (1.1) | 5.3 (1.0) |
| DAS28-ESR, mean (SD) | 6.3 (1.1) | 6.3 (1.2) | 6.0 (1.1) |
| HAQ-DI, mean (SD) | 1.5 (0.8) | 1.4 (0.7) | 1.3 (0.7) |
| RAMRIS erosion score, mean (SD) | 14.1 (13.4) | 13.2 (12.0) | 12.7 (12.0) |
| CARLOS, mean (SD) | 5.9 (9.4) | 8.1 (10.4) | 7.8 (10.9) |
| RAMRIS synovitis score, mean (SD) | 7.4 (4.8) | 7.9 (4.0) | 8.1 (4.9) |
| RAMRIS osteitis score, mean (SD) | 6.1 (6.7) | 8.8 (9.0) | 6.8 (8.3) |
| Total Genant-modified Sharp radiographic score, mean (SD) | 20.2 (18.9) | 17.9 (16.6) | 19.8 (18.8) |
| Annualised radiographic progression rate, mean (SD) | 6.3 (6.7) | 6.8 (8.9) | 5.7 (7.4) |
CARLOS, cartilage loss score; CRP, C reactive protein; CS, corticosteroids; DAS28, Disease Activity Score in 28 joints; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire Disability Index; MTX, methotrexate; RA, rheumatoid arthritis; RAMRIS, RA MRI Scoring; SJC, swollen joint count; TJC, tender joint count.