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ARTICLE | Clinical News

CCX354: Additional Phase II data

June 25, 2012 7:00 AM UTC

Additional data from the double-blind, international Phase II CARAT-2 trial in 160 patients showed that once-daily 200 mg oral CCX354 missed the secondary endpoints of improving ACR50 (30% vs. 20%, p=0.32) and ACR70 response rates (21% vs. 13%, p=0.36) at week 12 vs. placebo. The twice-daily 100 mg dose of CCX354 also missed both endpoints (29% and 11%, respectively, p=0.28 and p=0.82). The most common adverse events were headache, nasopharyngitis and nausea. The trial enrolled patients with moderate to severe RA who were on stable methotrexate therapy for at least 8 weeks, had >=8 swollen and tender joint counts, and CRP levels >=5 mg/mL at baseline. Data were presented at the European League Against Rheumatism meeting in Berlin and published in the Annals of the Rheumatic Diseases. ...