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news.Chelsea Therapeutics has started patient recruitment in a multinational, 12-week, double-blind Phase II trial designed to compare the efficacy and tolerability of CH-4051 against Methotrexate (MTX) in 250 patients with rheumatoid arthritis (RA) who are experiencing an inadequate response to MTX treatment
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The primary efficacy analysis will be conducted using the hybrid American College of Rheumatology, or ACR, score (hACR), which allows for a more comprehensive assessment of treatment benefit across all seven symptomatic and functional components of the standard ACR 20/50/70 evaluations historically used in RA trials.
Chelsea plans to conduct an un-blinded interim efficacy analysis after approximately 50% of patients in the two lower CH-4051 dose groups complete treatment and expects to report results from this analysis in the third quarter of 2011.
Chelsea president and CEO Simon said that there is a significant unmet medical need for safe and effective treatment options for RA patients who fail to achieve a good clinical outcome on methotrexate.
“Based on the available data, we believe that oral treatment with CH-4051 has the potential to significantly reduce joint pain and swelling as well as have disease-modifying effects in patients who have not responded well or have difficulty tolerating methotrexate and who might otherwise be moved onto more costly, biological injectable monoclonal therapies,” Pedder said.