UCB announces start of the EXXELERATE clinical study in rheumatoid arthritis
UCB announced the start of the EXXELERATE™ study which will evaluate the short- and long-term efficacy of Cimzia® (certolizumab pegol) plus methotrexate (MTX) compared with that of Humira®* (adalimumab) plus MTX in the treatment of moderate to severe rheumatoid arthritis (RA). The start of this study confirms previously announced plans.
"This head-to-head study is an important milestone. We believe that EXXELERATE™ should help to provide additional evidence to support early, informed management decisions for people living with this chronic, progressive disease," said Professor Dr Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President UCB.
The primary objectives of the study are to compare the relative efficacy of the two anti-TNF therapies during short- and long-term treatment (12 and 104 weeks respectively).
"While meta-analyses from placebo controlled trials suggest differences in efficacy among anti-TNFs in RA, results from the EXXELERATE™ study should help to provide additional insights to support the current lack of head-to-head data and to guide treatment decisions.” said Roy Fleischmann, MD, Clinical Professor of Medicine, The University of Texas South Western Medical Centre, Dallas, Texas, US. “As recent guidelines on biological agents recommend rapid treatment to target for RA patients, it is also timely for EXXELERATE™ to explore the comparative long term benefits of anti-TNF therapies, related to early response-driven treatment decisions.”
EXXELERATE™ is a multi-centre, single-blind, randomized, parallel-group study which will randomise patients to either certolizumab pegol plus MTX or adalimumab plus MTX. After 12 weeks, patients who respond will continue their initial treatment whereas non-responders will switch to the alternative treatment arm until study end at 104 weeks. By including a week 12 response-based therapeutic decision, EXXELERATE™ aims to assess the impact of early response-driven treatment on long-term (104 weeks) clinical and patient outcomes. The study aims to enroll approximately 900 adult patients with moderate-to-severe RA in multiple geographies including USA, Canada and Europe, who have inadequately responded to MTX and who have not previously received anti-TNF treatment. The headline results from the study are expected in 2016.
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