Abbott Laboratories announced the expansion of its immunology clinical trials program to include an additional Phase III study evaluating the potential of Humira (adalimumab) in Crohn's disease. Crohn's disease is an autoimmune disorder in which a human protein, tumor necrosis factor-alpha (TNF-a), has been suggested to play a role in the disease development. Data from clinical studies suggest that treatments that inhibit TNF-a may be effective in these disease states. Humira, which is a human monoclonal antibody that resembles antibodies normally found in the body, works by specifically blocking TNF-a.

"Abbott is committed to exploring the full therapeutic potential of Humira," said Jim Lefkowith, divisional vice president, Immunosciences Development, Abbott Laboratories. "Based on the recent approval of Humira for rheumatoid arthritis, we're excited to be expanding programs that will help us understand the effect of Humira in other autoimmune diseases, in addition to our continued programs in rheumatoid arthritis."

A Phase III study has been initiated that will evaluate the safety and efficacy of Humira in the induction and maintenance of clinical remission in subjects with moderately to severely active Crohn's disease. Patients in the trial will be randomized to receive Humira or placebo and response to treatments will be measured according to the Crohn's Disease Activity Index (CDAI) score. The CDAI is a commonly used tool that measures factors such as weight loss and abdominal pain. This study is in addition to the Phase III Crohn's study initiated in 2002.