Brussels-based UCB has initiated C-EARLY, a phase III study to evaluate the efficacy and safety of Cimzia (certolizumab pegol) in combination with methotrexate (MTX) for inducing and sustaining clinical response in adults with rheumatoid arthritis (RA) not previously treated with disease-modifying antirheumatic drugs (DMARDs).
The study also aims to assess whether the frequency of certolizumab pegol 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.
"There is growing evidence to support the value of detecting and treating rheumatoid arthritis patients as soon as possible after the onset of disease in order to prevent disease progression. By rapidly achieving the target of sustained remission early in the course of RA, drug-free remission could become an achievable goal," said Professor Paul Emery, professor of rheumatology, University of Leeds, U.K.
C-EARLY is a phase III, multi-center, randomized, double-blind, placebo-controlled study that will randomize patients diagnosed with early, progressive, active, moderate to severe RA to certolizumab pegol plus methotrexate (MTX) or placebo plus MTX for 52 weeks. Patients who achieve sustained remission with certolizumab pegol at week 52 will be re-randomized to varying reduced doses of certolizumab or withdrawn from certolizumab for a further 52 weeks.
The co-primary efficacy variables are the proportion of patients reaching sustained remission at week 52, and the proportion of patients who maintain low disease activity between week 52 and week 104. The study aims to enroll approximately 800 adult patients in the U.S., Canada and Europe who are naive to DMARDs. Headline results for the study are expected in 2016.