STUDY DESIGN

GO-FORWARD was a multicenter, randomized, double-blind, placebo-controlled study in 444 adult patients who had moderately to severely active rheumatoid arthritis despite a stable dose of ≥15 mg/week of methotrexate (MTX) and who had been previously treated with a TNF (tumor necrosis factor) blocker. Moderately to severely active rheumatoid arthritis (RA) was defined as ≥4 swollen joints (out of 66 total) and ≥4 tender joints (out of 68 total) and at least 2 of the following: (1) C-reactive-protein (CRP) ≥1.5 mg/dL or erythrocyte sedimentation rate (ESR) by the Westergren method of ≥28 mm/hr, (2) ≥30 minutes of morning stiffness, (3) bone erosion determined by X-ray and/or MRI (magnetic resonance imaging), or (4) anti-cyclic citrullinated peptide (anti-CCP) antibody-positive or rheumatoid factor (RF)-positive. Patients were randomized to receive placebo + MTX (n=133), SIMPONI® 50 mg + MTX (n=89), SIMPONI® 100 mg + MTX (n=89), or SIMPONI® 100-mg monotherapy + placebo + MTX (n=133). At Week 16, patients with <20% improvement from baseline in both tender and swollen joint counts had their study medication adjusted in a double-blind fashion (ie, early escape). Early-escape patients in the placebo + MTX group began receiving SIMPONI® 50 mg every 4 weeks. Early-escape patients in the SIMPONI® 50 mg + MTX group had their SIMPONI® dose increased from 50 mg every 4 weeks to 100 mg every 4 weeks. Both groups continued to receive MTX. At Week 24, all patients remaining in the placebo + MTX group who had been receiving placebo injections began receiving SIMPONI® 50 mg in a blinded fashion. Because the 100-mg dose is not part of the approved dosing regimen for SIMPONI®, only 50-mg results are shown. There was no clear evidence of improved ACR response with the higher SIMPONI® dose group (100 mg).^1,2