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

Findings Also Showed Patients Experienced Improvements in Quality of Life Measures and Fatigue Despite Treatment with Other Anti-TNFs or Methotrexate

SAN FRANCISCO, Oct. 27 /PRNewswire/ -- Results from two Phase 3 studies showed that patients receiving every four week subcutaneous injections of golimumab (CNTO 148) 50 mg or 100 mg, an investigational therapy, experienced significant improvements in physical function, health-related quality of life (HRQOL) and fatigue. The data from the randomized, double-blind, placebo- controlled studies in patients with active moderate to severe rheumatoid arthritis (RA) were presented at the American College of Rheumatology (ACR) Annual Scientific Meeting. The first trial was in patients who were previously treated with anti-tumor necrosis factor (TNF) agents and the second study was in patients who were active despite ongoing treatment with methotrexate.

"In addition to reducing signs and symptoms, these data show improvement in important measures of functional ability and quality of life," said Jonathan Kay, M.D., Director, Clinical Trials, Rheumatology Unit, Massachusetts General Hospital; Associate Clinical Professor of Medicine, Harvard Medical School, and lead study investigator. "These data support the potential benefit of golimumab in patients previously treated with anti-TNF therapies or methotrexate."

In the study, GOlimumab After Former anti-TNF Therapy Evaluated in RA (GO-AFTER), 50 mg and 100 mg doses of golimumab were studied in patients who had active RA and who were previously treated with anti-TNF treatments, but where anti-TNF treatment had been discontinued due to lack of efficacy (58 percent), intolerance (17 percent) or other reasons (40 percent). Patients continued to receive stable doses of methotrexate, sulfasalazine and/or hydroxychloroquine if they were receiving them at baseline. Golimumab-treated patients who had discontinued previous anti-TNF treatment for any reason experienc
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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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