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An adaptive dose-ranging, multi-center, single-blind, double-dummy, active-controlled trial to determine the target dose of canakinumab (ACZ885) in the treatment of acute flares in gout patients who a...

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-004666-61

An adaptive dose-ranging, multi-center, single-blind, double-dummy, active-controlled trial to determine the target dose of canakinumab (ACZ885) in the treatment of acute flares in gout patients who are refractory or contraindicated to NSAIDs and/or colchicine

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Extrait

The primary objective is to determine the target dose of canakinumab for the treatment of acute flares in gout patients who are refractory or contraindicated to NSAIDs and/or colchicine. The target dose is the dose that leads to the same efficacy as the comparator and will be identified by assessing the dose response relationship of various doses of canakinumab with regards to the pain intensity in the target joint at 72 hours (Day 4) post-dose measured on a 0-100 mm Visual Analog Scale (VAS).

Critère d'inclusion

  • Acute gout (patients who are refractory or contraindicated to NSAIDs and/or colchicine)

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