MedicalResearch.com Interview with: Sean Connolly, Ph.D. Director of Non-Registrational Data Generation Study Director for ASCORE Bristol-Myers Squibb MedicalResearch.com: What is the background for this study? Response: ASCORE is a two-year, prospective multicenter study to observe retention and response rates of moderate-to-severe rheumatoid arthritis (RA) patients receiving ORENCIA® (abatacept), administered subcutaneously via a pre-filled syringe, in routine clinical practice. Findings shared at the Annual European Congress of Rheumatology (EULAR 2019) are the results from the first 12 months. An important objective of our development program is to understand how well we can replicate findings from our clinical trials among a real-world patient population. In the case of ASCORE, which looked at approximately 3,000 patients, both bio-naïve and patients receiving later-line therapies, these data add to the body of research that may help inform physicians treating patients with RA. Patients participating in ASCORE were divided into two distinct cohorts at the outset of the study: bio-naïve and patients previously administered one or more biologic agents. The primary endpoint is to estimate the rentention rate of patients in each cohort over a 24-month period. Furthermore, ASCORE examines the patient populations across ten countries to understand factors including: how ORENCIA is prescribed, characteristics of patients from each country (socio-demographic data, medical history, co-morbidities, etc.), and population health statistics within each country. This sub-analysis is factored into patient response to treatment across both cohorts, which may help physicians better understand how and why certain populations demonstrate a specific retention rate. (more…)