GSK initiates Phase III rheumatoid arthritis programme
21 November 2007 00:00 in Pharmaceutical Company Product News
GlaxoSmithKline (GSK) and Genmab have initiated a Phase III programme investigating the use of ofatumumab in the treatment of rheumatoid arthritis (RA).
The programme will comprise of two studies which will be conducted outside the US with two distinct patient populations.
One study will be in patients who have previously had an inadequate response to methotrexate therapy while the other study will look at patients who have had an ineffective response to TNF-alpha antagonist therapy.
Dr Moncef Slaoui, chairman of research and development at GSK, expressed the company's delight in commencing the studies.
"We are very pleased that our collaboration with Genmab has progressed so that we can now move to the next step of the clinical trial programme," he said.
Each study will assess the efficacy of ofatumumab in reducing the signs and symptoms in RA patients after a single course of the agent which will comprise of a 24-week blinded period and 120-week open-label period.
Further studies in support of the Phase III programme are expected for next year.
Also this week, GSK and the European Foundation for the Study of Diabetes have announced a total of one million euros (0.715 million pounds) for diabetes research in Europe for 2007 and 2008.
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