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This excerpt taken from the ELN 20-F filed Mar 30, 2006. SENTINEL
Phase 3 Add-on Trial
The SENTINEL trial, also a two-year study, was a randomized,
multi-center, placebo-controlled, double blind study of
1,171 patients in 123 clinical trial sites worldwide. The
trial was designed to determine if adding Tysabri to
ongoing Avonex therapy is more effective than continuing Avonex
treatment alone in slowing the rate of disability in MS at two
years and in reducing the rate of clinical relapses at one and
two years in patients with evidence of relapses despite Avonex
therapy.
Patients in the SENTINEL trial were required to have relapsing
forms of MS, be on Avonex treatment for at least one year, and
have experienced at least one relapse in the previous year. All
patients continued to receive once-weekly Avonex and were
randomized to add either a 300 mg IV infusion of Tysabri
(n= 589) or placebo (n=582) every four weeks.
At one year, the addition of Tysabri to Avonex resulted
in a 54 percent reduction in the rate of clinical relapses
over the effect of Avonex alone. An annualized relapse rate of
0.36 was seen with Tysabri when added to Avonex versus
0.78 with Avonex plus placebo.
All secondary endpoints were also met. In the group treated with
Tysabri plus Avonex, 67 percent of patients
developed no new or newly enlarging T2 hyperintense lesions
compared to 40 percent in the Avonex plus placebo-treated
group. On the one-year MRI scan, 96 percent of Tysabri
plus Avonex-treated patients had no gadolinium-enhancing
lesions compared to 76 percent of Avonex plus
placebo-treated patients. The proportion of patients who
remained relapse-free was 67 percent in the Tysabri
plus Avonex-treated group compared to 46 percent in the
Avonex plus placebo-treated group.
In July 2005, we and Biogen Idec announced that SENTINEL
achieved the two-year primary endpoint of slowing the
progression of disability in patients with relapsing forms of
MS. The addition of Tysabri to Avonex resulted in a
24 percent reduction in the risk of disability progression
compared to the effect provided by Avonex alone. Data from
SENTINEL also demonstrated that the addition of Tysabri
to Avonex led to a 56 percent relative reduction in the
rate of clinical relapses compared to that provided by Avonex
alone. The reduction in relapse rate was statistically
significant and sustained over the entire two-year study period.
Other efficacy data from SENTINEL at two years, including MRI
measures and immunogenicity, were similar to previously reported
one-year results. Data from SENTINEL was published in the New
England Journal of Medicine in March 2006.
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