The purpose of this study is to determine the safety and efficacy of anti-IL-12 antibody therapy in active Crohn's disease. During this year we screened 11 and enrolled 8 subjects in this protocol. All successfully completed the treatment phase, and are now in follow-up. Two subjects had exacerbations of their disease 12 weeks after the last dose of study drug, and were transferred to standard therapy. This study uses a placebo-controlled, double-blind design, but 80% of enrolled subjects get the active compound. Assuming a majority of subjects received the active compound, we have observed significant improvement in clinical symptoms of disease, improvement of the endoscopic appearance of disease, and evidence of colonic mucosal inflammatory effector cell apoptosis following administration of the study drug. This study has just been completed and is in the analysis phase. The only significant change to the protocol was the eventual exclusion of women of child-bearing potential due to potential effects on fetal reproductive organ development. We enrolled 9 subjects at the NIH. We plan to terminate this protocol prior to the next continuing review.
