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UCB Pharma outlines positive preliminary results from second pivotal CDP 870 Phase III trial in rheumatoid arthritis

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Brussels, 21st September 2004 – UCB Pharma today announces positive preliminary results from the second Phase III clinical trial with CDP-870 in rheumatoid arthritis (“Study 011”). CDP-870 was designed and developed by Celltech, which recently became part of UCB. Study 011 assessed the safety and efficacy of CDP-870 as monotherapy on signs and symptoms of disease over a six month period in patients who had active moderate to severe disease despite previous treatment with methotrexate and other disease modifying anti-rheumatic drugs (“DMARDs”).

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. Adverse events in Study 011 were consistent with those seen in previous studies with CDP-870.

Roch Doliveux, Chief Executive Officer of UCB Pharma, commented: “CDP-870 has now clearly demonstrated its safety and efficacy, since we obtained positive results in both monotherapy and combination therapy Phase III clinical trials in rheumatoid arthritis. Our focus going forward is on developing a more patient-friendly formulation and delivery system, as well as further enhancing the competitive profile of this very promising drug.”

Concurrently, UCB Pharma continues to progress rapidly the double-blinded Phase III trials with CDP-870 in Crohn's disease for which enrolment will be completed by the end of the year.

CDP-870 is the first anti-TNF-alpha pegylated antibody fragment (FAb) for the treatment of rheumatoid arthritis and Crohn's disease; this confers the molecule with unique properties in terms of affinity, selectivity and duration of action.

Full results will be released after conclusion of the entire RA Phase III programme.


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