MedicalResearch.com Interview with: Atul A. Deodhar, MD, MRCP, FACP, FACR Professor of Medicine Medical Director, Rheumatology Clinics Medical Director, Immunology Infusion Center Oregon Health & Science University  MedicalResearch.com: What is the background for this study? Response: The GO-ALIVE study (CNTO148AKS3001) is a multicenter, randomized, double-blind, placebo-controlled study of golimumab, an anti-TNFα monoclonal antibody, administered intravenously (IV), in adult patients with active ankylosing spondylitis (AS). The primary objective is to evaluate the efficacy of golimumab 2 mg/kg in patients with active AS by assessing the reduction in signs and symptoms of AS. The secondary objectives include assessing efficacy related to improving physical function, range of motion, health-related quality of life, and other health outcomes. A total of 208 patients who had a diagnosis of definite  ankylosing spondylitis (per modified New York criteria) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4, total back pain visual analogue scale (VAS) ≥4, and CRP ≥0.3 mg/dL were randomized.  Patients were treated with IV golimumab (n=105) at Weeks 0, 4, and every 8 weeks through Week 52 or placebo (n=103) at Weeks 0, 4, and 12, with crossover to IV golimumab at Week 16 and through Week 52. (more…)