Belgium-based UCB has initiated the C-EARLY Phase III study to assess the efficacy and safety of Cimzia (certolizumab pegol) plus methotrexate (MTX) in adults with early, progressive, active, moderate to severe rheumatoid arthritis (RA) who have not previously been treated with disease-modifying antirheumatic drugs (DMARDs).
Cimzia is a PEGylated anti-TNF (tumour necrosis factor) that plays a crucial role in mediating pathological inflammation.
The Phase III multi-centre randomised double-blind placebo-controlled C-EARLY study will enrol around 800 adult patients diagnosed with early, moderate to severe RA to Certolizumab pegol in combination with MTX or placebo plus MTX for 52 weeks.
The study also evaluates whether the frequency of certolizumab pegol administration can be reduced after sustained low disease activity has been achieved in patients in the early stage of the disease.
Patients who achieve sustained remission with Certolizumab pegol at week 52 will be re-randomised to varying reduced doses of certolizumab pegol or withdrawn from certolizumab for a further 52 weeks.
The trial’s co-primary efficacy variables include 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.
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Paul Emery, Professor of Rheumatology at the University of Leeds, UK, said that by rapidly achieving the target of sustained remission early in the course of RA, drug-free remission could become an achievable goal.
"With C-EARLY we are starting an important study which should inform all stakeholders, including patients, rheumatologists and payers, how to optimise anti-TNF treatment in patients with early RA who have achieved sustained low disease activity," Emery added.
The European League Against Rheumatism (EULAR) recommends that DMARD treatment of RA is intended to achieve remission or low disease activity as soon as possible in every patient.
The findings from the study are likely to be announced in 2016.
UCB is a global biopharmaceutical company engaged in the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or central nervous system.