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news.Chelsea Therapeutics International has completed patient enrollment in its Phase II trial comparing the efficacy and tolerability of daily oral doses of CH-1504, a metabolically inert antifolate, to a standard weekly dose of methotrexate in rheumatoid arthritis patients.
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A total of 200 patients were enrolled in this 12-week, four-arm, parallel group Phase II clinical trial designed comparing 0.25mg, 0.5mg and 1mg once daily oral doses of CH-1504 versus a 20mg once weekly oral dose of methotrexate (MTX) in an MTX naive rheumatoid arthritis patient population.
The primary efficacy endpoint of this study is to determine the percent of patients with American College of Rheumatology (ACR) 20 response at the end of 12 weeks. An ACR 20 response is a standard efficacy measure that requires at least a 20% improvement in a number of different measures of disease activity.
As the improved safety and tolerability of CH-1504 is expected to be a significant advantage over MTX, the trial will also compare a cluster of gastrointestinal system related adverse events, such as nausea, vomiting and diarrhea, frequently seen with MTX use as well as closely monitor the results of standard liver function tests across dose groups.
Simon Pedder, president and CEO of Chelsea Therapeutics International, said: “Having recently received a favorable recommendation from an independent data safety monitoring board and now having completed full enrollment, we continue to be very pleased with the progress of this trial and look forward to providing top line data in the first quarter of 2009.”