C-EARLY Phase III study of Cimzia (UCB) begins for Rheumatoid Arthritis patients

A Phase III study to evaluate the efficacy and safety of Cimzia (certolizumab pegol), from UCB, in combination with methotrexate (MTX) for adults with early moderate to severe Rheumatoid Arthritis, has begun. The C-EARLY study also aims to assess whether the frequency of Cimzia administration can be reduced after sustained low disease activity has been achieved. C-EARLY will evaluate patients in the early stage of their disease less than one year since diagnosis. It will randomise patients diagnosed with early, moderate to severe RA to Cimzia plus MTX or placebo plus MTX for 52 weeks. Patients who achieve sustained remission with Cimzia at week 52 will be re-randomized to varying reduced doses or withdrawn from Cimzia for a further 52 weeks. The study aims to enroll approximately 800 adult patients in the US, Canada and Europe. Headline results for the study are expected in 2016.