Disposition of patients up to week 48
| Patients, n (%) | Placebo + MTX | Rituximab 2×500 mg + MTX | Rituximab 2×1000 mg + MTX |
|---|---|---|---|
| Randomised* | 172 (100) | 168 (100) | 172 (100) |
| Treated (first course)† | 172 (100) | 167 (99.4) | 170 (98.8) |
| Completed 24 weeks (placebo-controlled period) | 159 (92.4) | 162 (96.4) | 166 (96.5) |
| Retreated (second course) | 154 (89.5) | 152 (90.5) | 154 (89.5) |
| Received rescue treatment post week 24 | 16 (9.3%) | 6 (3.6%) | 4 (2.3%) |
| Leflunomide (n) | 5 | 1 | 1 |
| Hydroxychloroquine (n) | 4 | 2 | – |
| Sulfasalazine (n) | 3 | 1 | 3 |
| Cyclophosphamide (n) | 1 | – | – |
| Ciclosporin (n) | 3 | 2 | – |
| Completed 48 weeks (second course of rituximab) | 154 (89.5) | 157 (93.5) | 157 (91.3) |
| Withdrew before week 24 | 13 (7.6) | 6 (3.6) | 6 (3.5) |
| AE/intercurrent illness | 2 (1.2) | 2 (1.2) | 3 (1.7) |
| RA flare | 7 (4.1) | 1 (0.6) | 0 |
| Failure to return | 1 (0.6) | 1 (0.6) | 3 (1.7) |
| Violation of selection criteria at entry | 0 | 1 (0.6) | 0 |
| Withdrew consent | 3 (1.7) | 0 | 0 |
| Administrative/other | 0 | 1 (0.6) | 0 |
| Withdrew before week 48 | 18 (10.5) | 11 (6.5) | 15 (8.7) |
| AE/intercurrent illness | 3 (1.7) | 3 (1.8) | 7 (4.1) |
| Death | 0 | 2 (1.2) | 0 |
| RA flare | 11 (6.4) | 2 (1.2) | 0 |
| Failure to return | 1 (0.6) | 2 (1.2) | 4 (2.3) |
| Violation of selection criteria at entry | 0 | 1 (0.6) | 0 |
| Refused treatment/did not cooperate | 0 | 0 | 1 (0.6) |
| Withdrew consent | 3 (1.7) | 0 | 1 (0.6) |
| Administrative/other | 0 | 1 (0.6) | 2 (1.2) |