A 24-week, dose-ranging, multi-center, double-blind, double-dummy, active-controlled study to evaluate canakinumab (ACZ885) for prophylaxis of signs and symptoms of acute flares in chronic gout patien...

Mise à jour : Il y a 5 ans
Référence : EUCTR2008-005876-28

A 24-week, dose-ranging, multi-center, double-blind, double-dummy, active-controlled study to evaluate canakinumab (ACZ885) for prophylaxis of signs and symptoms of acute flares in chronic gout patients initiating allopurinol therapy

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Extrait

The primary objective of this study is: • To determine the target dose of canakinumab that leads to at least comparable efficacy as colchicine with respect to the mean number of gout flares occurring during 16 weeks after randomization. The target dose is defined as the minimum single dose that leads to at least the same efficacy as the comparator colchicine.


Critère d'inclusion

  • Prophylaxis of signs and symptoms of acute flares in chronic gout patients initiating allopurinol therapy