New SIMPONI(TM) Data Show Long-Term Efficacy in Treatment of Rheumatoid...(the first placebo-controlled double-blin...)

Date:10/19/2009

the first placebo-controlled, double-blind, Phase 3 registration trial that demonstrates the efficacy and safety of an anti-TNF-alpha agent in patients previously treated with other anti-TNFs. The trial included patients with active RA of 8.65 years mean duration. Discontinuation of previous anti-TNF-alpha therapy was to occur at least eight to 12 weeks prior to enrollment in the study. At baseline, 66 percent of patients were receiving methotrexate; five percent and eight percent of patients were receiving sulfasalazine and hydroxychloroquine, respectively. Patients continued to receive stable doses of methotrexate, sulfasalazine and/or hydroxychloroquine if receiving them at baseline. At week 16, patients with less than a 20 percent improvement in tender and swollen joint counts were entered into a double-blinded early escape. Those who did not achieve ACR 20 response at week 16 while taking placebo were given SIMPONI 50 mg every four weeks. Those who qualified for early escape and had been taking SIMPONI 50 mg were given SIMPONI 100 mg and those who had been receiving SIMPONI 100 mg continued to receive that dosing.

At least one adverse event was reported in 76 percent of patients receiving SIMPONI 50 mg or SIMPONI 100 mg with 13 and eight percent of patients, respectively, experiencing a serious adverse event. Serious infections were reported in four percent of patients receiving SIMPONI 50 mg and three percent of patients taking SIMPONI 100 mg, and injection site reactions were reported in one percent and two percent of patients, respectively.

About the GO-FORWARD Trial

GO-FORWARD, a Phase 3, multi-center clinical trial, includes adult patients with active RA and more than four tender and swollen joints, despite methotrexate therapy. Patients were randomly assigned to receive SIMPONI (50 or 100 mg) plus methotrexate, SIMPONI 100 mg plus placebo or placebo plus methotrexate at weeks 0, 4, 8, 12, 16 and 20.
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SOURCE Centocor Ortho Biotech Inc. Copyright©2009 PR Newswire. All rights reserved

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