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Phase III Trial of CDP870 in Rheumatoid Arthritis Meets Primary Endpoint
This study met its primary endpoint, as assessed by the number of patients achieving a 20% reduction in the American College of Rheumatology score ("ACR20 response") at 24 weeks. A significant ACR20 response was seen at week 1 in the study, the first time point, and was maintained for the duration of the study. The profile of adverse events in Study 014 was consistent with those seen in previous studies with CDP870.
Celltech intends to submit the detailed results from Study 014 for presentation at a future major scientific meeting.
Following this announcement, Celltech intends to continue advanced discussions with prospective partners for CDP870 with a view to entering a new collaboration agreement during the second quarter of 2004.
Celltech anticipates that the second Phase III trial of CDP870 in rheumatoid arthritis ("Study 011"), designed to assess the safety and efficacy of CDP870 as monotherapy on signs and symptoms of disease over a six month period in patients with moderate to severe disease, will conclude in the third quarter of 2004. Planning is currently in progress to commence the remaining Phase III programme in the second half of 2004.
Celltech continues to progress Phase III trials with CDP870 in Crohn's disease, with regulatory submissions in this indication planned for 2005. Celltech is also formulating plans for development of CDP870 in new disease indications, such as psoriasis, psoriatic arthritis and ankylosing spondylitis.
Dr. Goran Ando, Chief Executive Officer, commented: "The positive results from this Phase III clinical trial with CDP870 in rheumatoid arthritis underpin Celltech's confidence that this drug has a very promising future."
Source: Celltech Group