UCB has announced the start of C-EARLY™ - a phase III study that will evaluate the efficacy and safety of Cimzia® (certolizumab pegol) in combination with methotrexate (MTX) for inducing and sustaining clinical response in adults with early, progressive, active, moderate to severe rheumatoid arthritis (RA), who have not previously been treated with disease-modifying antirheumatic drugs (DMARDs).
The study also aims to assess whether the frequency of certolizumab pegol administration can be reduced where sustained low disease activity has been achieved.
C-EARLY™ will evaluate patients in the early stage of their disease, that is less than one year since diagnosis.
"We are pleased to announce the start of this study which focuses on investigating treatment for people with early active RA and reflects our continuing commitment to improving the lives of patients at all stages of this severe, progressive disease," said Professor Dr Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President, UCB.
The European League Against Rheumatism (EULAR) recommends that DMARD treatment of RA should aim to achieve remission or low disease activity as soon as possible in every patient and that, once remission has been achieved, tapering of treatment can be considered.
Research has shown that achieving early control of disease activity can improve long term outcomes for patients with RA.
“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, UK.
Professor Emery continued, “With C-EARLY™ we are starting an important study which should inform all stakeholders including patients, rheumatologists and payers how to optimize anti-TNF treatment in patients with early RA who have achieved sustained low disease activity.”
C-EARLY™ is a phase III, multi-centre, randomized, double-blind, placebo-controlled study which will randomize patients diagnosed with early, 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remission with certolizumab pegol at week 52 will be re-randomized to varying reduced doses of certolizumab pegol or withdrawn from certolizumab for a further 52 weeks.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 enrol approximately 800 adult patients in the U.S., Canada and Europe with early, progressive, active, moderate to severe RA who are naïve to DMARDs. Headline results for the study are expected in 2016.