RE: Potnak18 Apr 2018 08:54
Excellent summary from a seasoned
ii poster “Reducing the placebo response rate is an art in any clinical trial.... I should point out it's my job to know much more about drug development than any small company.. If IMM are reading this my suggestion would be to present the Week 12 response rates - if they also show a superior effect to placebo then undertake a sustained response/remission analysis. The eligibility criteria of SLEDA>6 for inclusion will only help drive out the delta (difference between active and placebo) for the induction phase of the study at week 12 (see my previous post on induction vs maintenance) but will have little influence on the maintenance phase.. When you go out to Week 52, with your primary time-point, the baseline disease activity has less influence on driving out the delta, as a subjects disease activity 1 year ago is too far in the past, and will naturally change as part of the normal fluctuation of the disease over the longer term.. The analysis I would recommend (assuming week 12 was good) is to look at the proportion of patients in response at both Week 12 AND Week 52 (i.e. combined response rate for a single responder analysis). This will drive down the placebo response more so than the active (if superiority was also seen at week 12).. If positive you will still be able to use the data to support an NDA for a long-term label claim, but naturally will need another study with this as your endpoint (in patients with anti-dsDNA autoantibodies).. it may allow less patients to be needed for the next study though.. Good luck and would like to see some good out of this... all is not lost here... “
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