IMPROVEMENT IN PHYSICAL FUNCTION

HAQ-DI responses at Week 24 were not adjusted for multiplicity. Therefore, statistical significance has not been established.

Study design: GO-FURTHER™ was a global, multicenter, randomized, double-blind, placebo-controlled study in 592 adult patients who had moderately to severely active RA despite a stable dose of MTX (15-25 mg/week) for ≥3 months and who had not been previously treated with an anti-TNF agent. Moderately to severely active RA was defined as ≥6 swollen joints (out of 66 total) and ≥6 tender joints (out of 68 total), RF positive and/or anti-CCP antibody positive, and CRP ≥1.0 mg/dL. Patients were randomized to receive SIMPONI ARIA^® 2 mg/kg + MTX (n=395) or placebo + MTX (n=197) as a 30-minute IV infusion at Weeks 0 and 4, and then q8w through Week 100. At Week 16, patients in the placebo + MTX group with <10% improvement from baseline in both swollen joint count and tender joint count began receiving SIMPONI ARIA^® 2 mg/kg beginning with an induction regimen at Weeks 16 and 20, followed by maintenance infusions q8w in a blinded manner. At Week 24, all patients remaining in the placebo + MTX group began receiving SIMPONI ARIA^® 2 mg/kg beginning with an induction regimen at Weeks 24 and 28, followed by maintenance infusions q8w in a blinded manner. All patients continued to receive MTX. The primary endpoint was the percentage of patients achieving an ACR20 response at Week 14.²

ACR20=20% improvement in American College of Rheumatology criteria; CCP=cyclic citrullinated peptide; CRP=C-reactive protein; DMARD=disease-modifying anti-rheumatic drug; HAQ-DI=health assessment questionnaire-disability index; MTX=methotrexate; q8w=every 8 weeks; RA=rheumatoid arthritis; RF=rheumatoid factor; TNF=tumor necrosis factor; vdH‑S=van der Heijde Modified Sharp score.