This excerpt taken from the ELN 20-F filed Mar 30, 2006.
ENCORE Phase 3 Crohns Disease Trial
In June 2005, Elan and Biogen Idec reported the topline results of the second Phase 3 induction trial, ENCORE, for the treatment of moderately to severely active CD in patients with evidence of active inflammation. ENCORE met the primary endpoint of clinical response as defined by a 70-point decrease in baseline Crohns Disease Activity Index (CDAI) score at both weeks 8 and 12.
In addition, ENCORE met all of its secondary endpoints including clinical remission at both weeks 8 and 12. Clinical remission was defined as achieving a CDAI score of equal to or less than 150 at both weeks 8 and 12.
There were no notable differences in the overall rates of adverse events or serious adverse events between the Tysabri and the placebo treatment groups. The most common adverse events seen in the trial were headache, nausea, abdominal pain and nasopharyngitis. The full ENCORE data set will be presented during the 2006 Digestive Disease Week (DDW) conference in May.
ENCORE was a Phase 3, international, double-blind, placebo-controlled study of 510 patients at 114 sites to evaluate the safety and efficacy of intravenous Tysabri in patients with moderately to severely active CD (based on a confirmed diagnosis of CD and a CDAI score of greater than or equal to 220 and less than or equal to 450) and evidence of active inflammation (as evidenced by elevated C-reactive protein levels of greater than 2.87 mg/l, the upper limit of normal). Patients were randomized 1:1 to treatment with Tysabri (300 mg IV) or placebo infusions at weeks 0, 4, and 8. Efficacy and safety assessments were performed at weeks 4, 8 and 12.
At the time of the voluntary suspension of Tysabri dosing in all ongoing clinical trials (February 2005), all ENCORE study patients had completed dosing based on the study protocol.