Genmab, GSK Start Ofatumumab Phase III Program

Danish drugmaker Genmab and GlaxoSmithKline (GSK) have begun the Phase III program with ofatumumab to treat rheumatoid arthritis (RA).

The program will involve two studies outside the U.S. One study will include patients who have had an inadequate response to methotrexate therapy, and the other will involve patients who have had an inadequate response to tumor necrosis factor-alpha antagonist therapy. 

Each study will evaluate the efficacy of the drug in reducing the clinical signs and symptoms of RA after a single course. Both will include a 24-week, double-blind period followed by a 120-week, open-label period, during which retreatment will be studied.

Further studies to support the program are planned for 2008, Genmab said.