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Abbott expands Humira clinical trial program in Crohn's disease

ABBOTT PARK, ILL., September 29, 2003 -- 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, M.D., 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.

Crohn's disease is a chronic inflammatory disease of the gastrointestinal (GI) tract, usually beginning in late childhood or early adulthood. Common symptoms include diarrhea, abdominal pain, weight loss, fever, and in some cases rectal bleeding.

"Patients with Crohn's disease experience severe gastrointestinal symptoms because of an inflammatory response in the intestinal tract," said William Sandborn, M.D., professor of medicine, Mayo Medical School. "These patients have limited treatment options today. This trial is designed to assess the long-term effects of Humira on disease activity."

More information about Humira clinical trials can be obtained by calling Abbott Medical Information at 1-800-633-9110.

Important safety information

Cases of tuberculosis (TB), frequently disseminated or extra pulmonary at clinical presentation, have been observed in patients receiving Humira. Serious infections and sepsis, including fatalities, have been reported with the use of TNF-blocking agents, including Humira. Many of these infections occurred in patients on concomitant immunosuppressive therapy that in addition to their underlying disease could predispose them to infections. Other invasive opportunistic fungal inf

Posted: September 2003