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FUNCTION was a multicentre, double-blind, double-dummy, parallel-group, phase III trial in which patients were randomly assigned (1:1:1:1) to 4 mg/kg TCZ MTX, 8 mg/kg TCZ MTX, 8 mg/kg TCZ placebo or placebo MTX.
The randomisation sequence was stratified by serological status (presence of rheumatoid factor (RF) and/or anticyclic citrullinated peptide (anti-CCP) antibodies) and by geographical region.
Boolean criteria for ACR/EULAR remission require that the following be satisfied at the same visit: tender joint count (68) ≤1, swollen joint count (66) ≤1, Patient Global Assessment of Disease Activity (cm) ≤1, C-reactive protein ≤1 mg/d L.
The index-based definition of ACR/EULAR remission is an SDAI score ≤3.3.
DAS28-ESR remission and ACR response rates indicated improvement in RA signs and symptoms in the 8 mg/kg TCZ placebo and 4 mg/kg TCZ MTX groups at weeks 24 and 52 (table 2, figure 2B, C).ITT, intent-to-treat; MTX, methotrexate; TCZ, tocilizumab. Baseline demographics and disease characteristics were balanced among treatment groups (table 1).Overall, patients had very early RA (mean duration, 0.4–0.5 years) with little radiographic damage at baseline (mean m TSS score, 5.66–7.72).The trial was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. Adults (≥18 years) with moderate to severe active RA, classified according to revised 1987 American College of Rheumatology (ACR) criteria,17 of ≤2 years’ duration who had not previously received MTX or biological agents were included.Patients with features of poor prognosis were enrolled: inclusion criteria included Disease Activity Score using 28 joints and erythrocyte sedimentation rate (DAS28-ESR) 3.2, swollen joint count ≥4 (66 joint count), tender joint count ≥6 (68 joint count), ESR ≥28 mm/h or C reactive protein ≥1 mg/dl, positive RF or anti-CCP antibodies or one or more erosion of hands, wrists or feet attributable to RA based on a central radiographic reading.