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Bristol-Myers Squibb to Present New Data on ORENCIA(R)? (abatacept) at the European League Against Rheumatism (EULAR) 2012 Congress
Date:5/14/2012

PARIS, May 14, 2012 /PRNewswire/ --


  • Results of head-to-head study comparing two biologic drugs on a background of methotrexate for the treatment of moderate to severe rheumatoid arthritis to be presented

Bristol-Myers Squibb Company (NYSE: BMY) today announced that the company will present 18 abstracts on abatacept at the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology in Berlin, June 6-9. Among the data being presented will be results from the AMPLE study, a head-to-head phase 3 clinical trial comparing subcutaneous (SC) ORENCIA® (abatacept) to HUMIRA® (adalimumab), both in combination with methotrexate. The combination of a biologic medication and methotrexate is the most commonly prescribed treatment approach in moderate to severe RA.

AMPLE (Abatacept Versus Adalimumab Comparison in Biologic-Naive RA Subjects With Background Methotrexate) is a randomized, controlled study powered to compare the efficacy of abatacept SC versus adalimumab on a background of methotrexate in adult, biologic naïve patients with moderate to severe RA. AMPLE is an ongoing 2 year study, with primary analyses at 1 year. In addition to assessing the primary endpoint of non-inferiority between abatacept SC and adalimumab as defined by the proportion of subjects achieving the American College of Rheumatology criteria of 20 percent improvement (ACR 20) after 12 months of treatment, the trial also evaluated the following secondary endpoints: frequency of injection site reactions, radiographic non-progression as assessed using the van der Heijde modified total Sharp score (mTSS) method, safety and retention. The study also evaluated addi
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