ABBOTT PARK, Illinois, March 30, 2011 /PRNewswire/ -- Abbott announced today it enrolled the first patient in the CALM Study, a clinical trial with HUMIRA(R) (adalimumab), to determine if tailoring therapy to more stringent measures of disease activity in patients with early moderate to severe Crohn's disease will improve mucosal healing. The study will assess patients monitored with those stringent criteria over 56 weeks compared to patients monitored with less stringent and more commonly used clinical disease management criteria. This international study is enrolling now in Austria, Belgium, Canada, Czech Republic, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, and the UK with the goal to research the response rates of approximately 240 people diagnosed with Crohn's disease for less than four years who have had no more than one course of corticosteroids and are naive to immunosuppressive and biologic therapy.
"We know Crohn's disease can be difficult to treat and that early intervention may yield improved long-term outcomes," said Professor Jean-Frederic Colombel, head of Gastroenterology, University of Lille, France. "There are a number of objective measures by which we can quantify a therapy's effect. Assessing these important objective measurement tools may provide valuable information for physicians managing this disease."
The CALM study will evaluate tight control of disease activity, defined as using stringent criteria based on the Crohn's disease activity index (CDAI), high sensitivity C-reactive protein levels, the fecal Calprotectin test and the need for continued corticosteroid use, versus disease management based only on CDAI and corticosteroid use.
"The tight-control approach may offer a benchmark for drug therapies relative to symptomatic treatment," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott. "These important measures may provide strides toward understanding and defining objective disease management tools for Crohn's patients."
