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This excerpt taken from the ELN 20-F filed Mar 30, 2006. ENCORE
Phase 3 Crohn’s 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 Crohn’s 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.
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