Maxime Verhoeven

92 Chapter 5 Randomization: TCZ+MTX: enrolled = 279, dosed = 277 TCZ+placebo: enrolled = 277, dosed = 276 FUNCTION: Design: Four-arm, double blinded, double-dummy randomized, parallel-group, pivotal PhaseIII, multi-center trial. Inclusion: Men and women, ≥18 years, with moderate-to-severe active early RA (duration ≤2 years at baseline) who had not previously been treated with MTX or biologic agent. Randomization: TCZ+MTX 8mg/kg: enrolled = 291 TCZ+placebo 8mg/kg: enrolled = 292 TCZ+MTX 4mg/kg: enrolled = 292 placebo+MTX: enrolled = 289 U-Act-Early: Design: A 2-year multicenter, three-parallel-arm, randomized, double-blind, double-dummy, treat-to-target strategy study of patients with newly diagnose RA. Inclusion: Men and women, ≥18 years, with early RA (duration ≤1 years at baseline) patients with an active disease (DAS28 >2.6). Randomization: TCZ+MTX 8mg/kg: enrolled = 106 TCZ+placebo 8mg/kg: enrolled = 103 placebo+MTX: enrolled = 108