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New One-Year Data from REMICADE(R) SONIC Trial Show Sustained Efficacy Compared with Azathioprine in Treatment of Crohn's Disease
Date:6/2/2009

NF-alpha therapy approved by the FDA for the treatment of moderately to severely active Crohn's disease for the reduction of the signs and symptoms in patients who have an inadequate response to conventional therapy. During the past decade, REMICADE has also become the first and only anti-TNF-alpha therapy approved by the FDA for the treatment of moderately to severely active ulcerative colitis, in patients with an inadequate response to conventional therapy, a related inflammatory bowel disease. REMICADE is also approved for the treatment of pediatric patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapies.

The SONIC study was supported by Centocor Ortho Biotech, Inc.

About SONIC

SONIC was a multicenter, Phase 3b, randomized, double-blind, controlled clinical trial designed to compare the efficacy and safety of REMICADE monotherapy, azathioprine monotherapy and combination therapy with the 2 drugs in patients with moderately to severely active Crohn's disease who were naive to immunomodulator and biologic therapy. A total of 508 patients from the U.S., Europe and Israel were enrolled in the study and were randomized into three groups; 170 patients received azathioprine less than or equal to 2.5 mg/kg/day and placebo infusions, 169 patients received REMICADE 5 mg/kg infusions at weeks 0, 2, 6 and every 8 weeks thereafter with placebo capsules and 169 patients received REMICADE 5 mg/kg and azathioprine less than or equal to 2.5 mg/kg/day at week 26. The primary endpoint of SONIC was to assess the induction of steroid-free remission at week 26. Patients completing treatment through week 30, and who, in the opinion of the investigator, may benefit from continued treatment, entered into the study extension beginning at week 30 through week 50.

SONIC previously demonstrated the effect of REMICADE therapy on steroid-free remiss
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SOURCE Centocor Ortho Biotech Inc.
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