Table 1

Disposition of patients up to week 48

Patients, n (%)Placebo + MTXRituximab 2×500 mg + MTXRituximab 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 2416 (9.3%)6 (3.6%)4 (2.3%)
 Leflunomide (n)511
 Hydroxychloroquine (n)42
 Sulfasalazine (n)313
 Cyclophosphamide (n)1
 Ciclosporin (n)32
Completed 48 weeks (second course of rituximab)154 (89.5)157 (93.5)157 (91.3)
Withdrew before week 2413 (7.6)6 (3.6)6 (3.5)
AE/intercurrent illness2 (1.2)2 (1.2)3 (1.7)
RA flare7 (4.1)1 (0.6)0
Failure to return1 (0.6)1 (0.6)3 (1.7)
Violation of selection criteria at entry01 (0.6)0
Withdrew consent3 (1.7)00
Administrative/other01 (0.6)0
Withdrew before week 4818 (10.5)11 (6.5)15 (8.7)
AE/intercurrent illness3 (1.7)3 (1.8)7 (4.1)
Death02 (1.2)0
RA flare11 (6.4)2 (1.2)0
Failure to return1 (0.6)2 (1.2)4 (2.3)
Violation of selection criteria at entry01 (0.6)0
Refused treatment/did not cooperate001 (0.6)
Withdrew consent3 (1.7)01 (0.6)
Administrative/other01 (0.6)2 (1.2)
  • * Although 512 patients are listed, 1 patient was randomised twice. The actual number of randomised patients is 511.

  • Intention-to-treat and safety populations.

  • AE, adverse event; MTX, methotrexate; RA, rheumatoid arthritis.