Quote:
Originally Posted by Riverwild
How about this one?
http://www.emea.europa.eu/humandocs/PDFs/EPAR/tysabri/H-603-en6.pdf
"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."
Elan and Biogen also addressed this in Phase 2. No rebound effect was observed. [/LEFT] |
The difference between that study, and the most recent findings is that:
- the follow-up period was very short; 6 months
- that study focused on gadolinium enhancement (which is said to be a transient phenomenon of MRI disease activity)
- this most recent study focused on the cumulative burden of disease (T2 lesions)
Cherie
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