The results from a study showing patients with moderate to severely active Crohn's disease treated with Adalimumab ( Humira ) were more likely to maintain clinical remission through one year than patients receiving a placebo, regardless of the frequency of the dosing regimen.
Data from CHARM ( Crohn's trial of the fully Human antibody Adalimumab for Remission Maintenance ) showed that remission rates were maintained through 56 weeks in patients who demonstrated response to Adalimumab during a four-week open-label induction phase.
Clinical remission was measured by a decrease in the Crohn's Disease Activity Index ( CDAI ). CDAI is a weighted composite score of eight clinical factors that evaluate patient wellness, including daily number of liquid or very soft stools, severity of abdominal pain, level of general well-being and other measures.
CHARM is a Phase III double-blind, placebo-controlled, multi-center, 56- week trial.
It was designed to assess the efficacy and safety of Adalimumab taken weekly and every other week, versus placebo, in maintaining clinical remission ( CDAI