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This excerpt taken from the ELN 20-F filed Mar 30, 2006. ENACT-2
Phase 3 Crohn’s Disease Maintenance
Trial
ENACT-2 was a Phase 3, double-blind, placebo-controlled,
international maintenance trial of Tysabri in CD enrolled
responders from ENACT-1 (a three-month double-blind,
placebo-controlled study in patients with moderately to severely
active CD). Tysabri responders from ENACT-1
(339 patients) were re-randomized after the three-month
study to one of two double-blind treatment groups: Tysabri
(300 mg IV) or placebo, both administered monthly
for a total of 12 months. The primary endpoint of ENACT-2
was sustained maintenance of response throughout the first six
months of treatment.
We presented six-month data from the ENACT-2 study at the DDW in
May 2004. Twelve-month ENACT-2 data was presented as part of a
regulatory filing announced and subsequently presented at the
12th Annual United European Gastroenterology Week meeting
in September 2004.
The data presented at the DDW showed Tysabri maintained
clinical response and remission rates throughout six months
among patients with Crohn’s disease who had previously
achieved clinical response. At six months, 61 percent of
Tysabri-treated patients exhibited significant clinical
response versus 28 percent of patients re-randomized to
receive placebo, and clinical remission was maintained by
44 percent of patients receiving Tysabri versus
26 percent of placebo-treated patients. Forty-nine percent
of Tysabri-treated patients who were also on chronic
corticosteroid therapy were able to withdraw from
corticosteroids and maintain response, in contrast to
20 percent of patients on placebo. There were no notable
differences in the rate of serious or non-serious adverse events
between treatment groups. The most frequently reported adverse
events were headache, nasopharyngitis, nausea and abdominal pain.
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