River...or anyone....
I am having a hard time following what this really means.
In the pdf article you linked there seems to be a contridiction, or am I reading this wrong?
You quoted supportive phase II study
Study MS 231
Quote:
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"The study met its primary endpoint in the number of new Gd-enhancing lesions from baseline to month 6 for both dosage groups in favour of natalizumab (p<0.001). After cessation of treatment, i.e. in the 6-month follow-up period (months 7-12), no further treatment effect was observed. Also, the number of new Gd-enhancing lesions did not exceed that of the placebo group, i.e. no rebound effect was observed concerning the number of lesions."
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But on page 23 I found this:
• Rebound after discontinuation
Data from the phase II study MS 231, where patients received 6 months of active treatment and a follow-up of additional 6 months after treatment discontinuation, suggested that there might be the danger of a subclinical rebound of MRI lesions, exceeding those in the placebo group.
Now I am really confused.
