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Golimumab Phase 3 Data Show Significant Improvement In Physical Function In Patients with Rheumatoid Arthritis
Date:10/27/2008

serious AEs, compared with 7 percent and 5 percent of patients in the golimumab 50 mg and golimumab 100 mg groups, respectively. Serious infections were reported in 3 percent, 3 percent and 1 percent of patients, and injection site reactions (ISR) through week 16 occurred in 3 percent, 4 percent and 11 percent of patients in the placebo, golimumab 50 mg and golimumab 100 mg groups, respectively. The most commonly reported ISR was erythema, a redness of the skin due to inflammation. No serious or severe ISRs were reported, and none led to the discontinuation of patients in the study. Antibodies to golimumab were detected in 4 percent of golimumab-treated patients (50 mg and 100 mg).

About the GO-FORWARD Trial

GO-FORWARD, a Phase 3, multi-center clinical trial included 444 patients with active RA. Adult patients with more than four tender and swollen joints, despite methotrexate therapy, were randomly assigned to receive golimumab (50 or 100 mg) plus methotrexate, golimumab 100 mg plus placebo or placebo plus methotrexate at weeks 0, 4, 8, 12, 16 and 20. Data were assessed at weeks 14 and 24. The co-primary endpoints were percentage of patients achieving ACR 20 response at week 14 and improvement from baseline in HAQ at week 24.

Through week 24, 68 percent of patients in both the combined golimumab plus methotrexate groups and the placebo plus methotrexate group experienced at least one AE. Nine percent of patients in the combined golimumab plus methotrexate groups experienced a serious AE compared with 4 percent of patients receiving placebo plus methotrexate. Three percent of patients in the combined golimumab plus methotrexate groups and 1 percent in the group receiving placebo plus methotrexate experienced serious infections. Rates of ISRs were 5 percent in the combined golimumab plus methotrexate groups and 3 percent in the group receiving placebo plus methotrexate. Two percent of golimumab-treated patients developed antibodies. Four patients
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SOURCE Centocor
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1. Centocor, Inc. and Schering-Plough Submit Application Requesting Approval of Golimumab in Europe for the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
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