Comparisons with disability data from placebo cohorts of other published phase III trials. End points measured at 2 years unless otherwise stated
Entry EDSS range | 2 year EDSS difference (unadjusted) | EDSS confirmed progression end points | |||||
---|---|---|---|---|---|---|---|
1.0-pt 3 months | 1.0-pt 6 months | 2.0-pt 6 months | |||||
This study: | |||||||
Total cohort | 0 to 5.0 | +0.38 | 32% | 21% | 9% | ||
Other relapsing-remitting MS studies: | |||||||
INFβ-1b1 | 0 to 5.5 | NA | 28% (3 years) | NA | NA | ||
INFβ-1a3 | 1.0 to 3.5 | +0.74 | NA | 35% | 18% | ||
IVIg4 | 1.0 to 6.0 | +0.12 | NA | 23% (unconfirmed) | |||
Secondary progressive MS study: | |||||||
INFβ-1b31 | 3.0 to 6.5 | +0.60 (3 years) | 50% (3 years) | NA | NA |
The 1.0 point 6 months end point for the IVIg trial wasnot confirmed as this was not an outcome measure used in the study.