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Most patients were also RF or anti-CCP antibody positive (89%–91% and 86%–87%, respectively). (B) Secondary and exploratory endpoints at week 24.
The ITT population comprised 1157 patients, and the safety population comprised 1153 patients. *Five patients (two in the placebo MTX group, two in the 4 mg/kg TCZ MTX group and one in the 8 mg/kg TCZ MTX group) did not receive study treatment and were excluded from analysis populations.
Before baseline, DMARDs were withdrawn for appropriate washout periods (see online supplementary appendix).
Patients could continue treatment with oral non-steroidal anti-inflammatory drugs and/or oral corticosteroids (≤10 mg/day prednisone or equivalent), provided the doses had been stable for at least 2 or 4 weeks before baseline, respectively, and remained stable throughout the study.
The safety population included all patients who received at least one TCZ/placebo infusion and had at least one post-dose safety assessment.
Overall, the study required 1128 patients (282 per arm) to provide 80% power to detect an absolute difference of 10% in DAS28-ESR remission (DAS28-ESR In total, 1162 patients were randomly assigned, and 920 (79%) completed 52 weeks of treatment; 96.1% of patients assigned to 4 mg/kg TCZ MTX, 8 mg/kg TCZ MTX or placebo MTX achieved MTX doses of 15 mg/week or higher (see online supplementary appendix, results and tables S2–S4).