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Phase 3 Data Show Intravenous Golimumab Inhibited Radiographic Progression in Patients with Active Rheumatoid Arthritis
Date:11/12/2012

osis and one death, a myocardial infarction secondary to community-acquired pneumonia, were reported in the I.V. golimumab group.  Through week 52, the proportions of infusions and patients with infusion reactions were 0.7 percent and 3.6 percent, respectively, (versus 1.1 percent and 3.5 percent at week 24, respectively).

About GO-FURTHER
The GO-FURTHER trial is a Phase 3, international multicenter, double-blind, placebo-controlled study including 592 adults with RA designed to compare ACR 20 response at week 14 in patients receiving an I.V. golimumab infusion  plus methotrexate compared with patients receiving placebo infusions plus methotrexate. The trial included patients diagnosed with active RA who had at least six tender and six swollen joints and who had been receiving background methotrexate for at least three months. Patients were randomized 2:1 to receive a 30 (+/- 10) minute I.V. infusion of golimumab  2 mg/kg or placebo plus methotrexate at weeks 0, 4, and then every eight weeks.  The primary endpoint of the study was ACR 20 at week 14.  At week 16, patients receiving placebo with less than 10 percent improvement in combined swollen and tender joint counts were entered into early escape to receive I.V. golimumab 2 mg/kg at week 16 and week 20.  All patients receiving placebo crossed over to I.V. golimumab at week 24. Radiographs of the hands and feet were taken at baseline, week 24 (week 16 for early escape participants) and week 52 and were scored using the modified vdHS score.  Week 24 results from the Janssen-sponsored study were presented earlier this year at the 2012 EULAR Annual Congress and also appeared in the Annals of the Rheumatic Diseases.

About Rheumatoid Arthritis 
Rheumatoid Arthr
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SOURCE Janssen Research & Development, LLC
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